Valeda × Improved ETDRS best-corrected visual-acuity letters in dry AMD — Evidence check sheet

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Efficacy comparison and presentation of stored materialHow does the selected BCVA question differ from the parent verdict?Required	The selected existing question is improved ETDRS best-corrected visual-acuity letters, with original C grade and note but no score, status or axes. Parent C50, Caution and original axes such as S/R1/I0/E+/B2 remain parent context. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Absent subclaim score, status and axes are not filled with parent values, and no new grade is written. Existing content review remains incomplete.	Separating subclaim C grade, note and absent values from parent C50, axes and original verdict	Proposal: Separate sources for the original question and verdict context. No new research, calculation or trial was performed.
2	Partly verified	Full text not readStored summary read	N02 · Efficacy comparison and presentation of stored materialWhat were LIGHTSITE III's actual population and recruitment conditions?Required	The original trial included 100 people with dry age-related macular degeneration at 10 US centers. Results are not extended to wet AMD, other acuity levels or stages, or other devices. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Exact stage, baseline BCVA, age/comorbidities, selection/exclusions and representativeness remain unverified. Existing content review remains incomplete.	Ten US centers, dry AMD, baseline acuity/stage and selection criteria	Proposal: Link BCVA materials by population conditions. No new research, calculation or trial was performed.
3	Partly verified	Full text not readStored summary read	N03 · Efficacy comparison and presentation of stored materialWhat were the historical Valeda and sham study exposures?Required	Valeda study conditions used 590, 660 and 850 nm light, with 9 sessions over 3~5 weeks repeated every 4 months. The sham was an active comparator delivering low-fluence light. These are not converted into device-use, setting or administration instructions. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Actual light dose, arm-specific exposure/adherence, device standardization, stopping/changes and concomitant-treatment details remain unverified. Existing content review remains incomplete.	Distinguishing original wavelengths, sessions/duration, repetition and comparator	Proposal: Distinguish device study conditions from actual exposure. No new research, calculation or trial was performed.
4	Partly verified	Full text not readStored summary read	N04 · Efficacy comparison and presentation of stored materialWhat units and procedures underlie 2:1 randomization and double masking?Required	LIGHTSITE III is described as a double-masked sham-controlled trial randomizing 100 participants and 148 eyes 2:1. Arm-specific people/eye counts and allocation units are not newly calculated. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Person/eye allocation unit, same-arm handling of bilateral eyes, sequence generation/concealment and maintenance of masking remain unverified. Existing content review remains incomplete.	100 participants and 148 eyes, allocation unit, concealment and bilateral-eye/center relationships	Proposal: Document allocation units and arm/center structure. No new research, calculation or trial was performed.
5	Partly verified	Full text not readStored summary read	N05 · Efficacy comparison and presentation of stored materialWhat denominators do 100 participants and 148 eyes represent?Required	100 participants and 148 eyes are the original randomized denominators. People are not converted into eyes, 148 independent participants or the analyzed eyes at every time point. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. People, eyes and observed/analyzed denominators by arm/time point, and handling of bilateral-eye correlation, remain unverified. Existing content review remains incomplete.	Distinguishing people, eyes, bilateral participation, analysis populations and repeated time points	Proposal: Link participant and eye denominators. No new research, calculation or trial was performed.
6	Partly verified	Full text not readStored summary read	N06 · Efficacy comparison and presentation of stored materialWhat observation losses do 20 discontinuations and original 20% attrition represent?Required	20 of 100 participants discontinued, and the original verdict describes 20% attrition. No remaining participant/eye counts, time-specific attrition rates or discontinuation reasons are calculated or filled in. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Discontinuations, eye counts, reasons, missing outcomes and analysis/imputation methods by arm/time point remain unverified. Existing content review remains incomplete.	Discontinued participants, time points/arms/eyes and missingness	Proposal: Link discontinued participants/eyes to analysis data. No new research, calculation or trial was performed.
7	Partly verified	Full text not readStored summary read	N07 · Efficacy comparison and presentation of stored materialHow do prespecified primary time points at months 13 and 21 differ from the month-24 report?Required	The original wording identifies months 13 and 21 as prespecified primary BCVA time points. Month-21 and month-24 BCVA values are preserved, without promoting month 24 to a prespecified primary time point. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Joint hierarchy for months 13/21, prespecified/follow-up status of month 24 and multiple-testing plans remain unverified. Existing content review remains incomplete.	Original prespecified BCVA time points, reporting time points, outcome hierarchy and multiplicity	Proposal: Link prespecified time points to reporting/follow-up time points. No new research, calculation or trial was performed.
8	Partly verified	Full text not readStored summary read	N08 · Efficacy comparison and presentation of stored materialWhat were month-21 PBM and sham changes and intervals?Required	Month 21 PBM +6.2 letters (95% CI 4.2~8.2), sham +2.4 (−.1~4.9), and between-arm P=.0036 are preserved. Arm-specific change CI are not transferred to a between-arm-difference CI. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Analyzed eyes/people by arm, exact between-arm-difference CI, adjustment/missingness and change baseline remain unverified. Existing content review remains incomplete.	Original LS BCVA changes +6.2/+2.4, arm-specific CI and between-arm P	Proposal: Document within-arm changes and between-arm comparison intervals. No new research, calculation or trial was performed.
9	Partly verified	Full text not readStored summary read	N09 · Efficacy comparison and presentation of stored materialIs the approximate 3.8-letter between-arm difference an original manuscript value?Required	The original counterview describes an approximate 3.8-letter between-arm LS mean difference at month 21. This original value is preserved; no new difference is calculated from +6.2/+2.4, and no exact CI or clinical-importance threshold is produced. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. The original difference CI, model/rounding, denominators and prespecified importance threshold remain unverified. Existing content review remains incomplete.	Distinguishing the original approximate 3.8 LS difference from arm changes and importance	Proposal: Link the original difference to interval and importance definitions. No new research, calculation or trial was performed.
10	Partly verified	Full text not readStored summary read	N10 · Efficacy comparison and presentation of stored materialWhich analysis produced month-24 changes and P?Required	Month-24 PBM +5.6 versus sham +1.3 letters, P=.0024, are recorded as in the original materials. They are not pooled with month 21 or used to create a new mean/difference or another trial. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Month-24 arm-specific/between-arm CI, denominators, model/missingness and prespecified hierarchy remain unverified. Existing content review remains incomplete.	+5.6/+1.3, P=.0024 and time-point/denominator/hierarchy	Proposal: Document time-specific estimands and analysis populations. No new research, calculation or trial was performed.
11	Unverified	Full text not readStored summary read	N11 · Efficacy comparison and presentation of stored materialDoes this summary contain results for the month-13 primary time point?Required	The original endpoint is BCVA change at months 13 and 21, but this preserved summary's quantitative reports concern months 21 and 24. Month-13 values, CI or P are not filled with values from other time points. S01	Required information is unverified in the preserved summary. Month-13 BCVA values, denominators, analysis/missingness and reporting hierarchy remain unverified in the preserved summary. Existing content review remains incomplete.	The original month-13 primary time point and gaps in actual values/denominators	Proposal: Link results and omissions at each prespecified time point. No new research, calculation or trial was performed.
12	Partly verified	Full text not readStored summary read	N12 · Efficacy comparison and presentation of stored materialIs a statistically significant letter difference clinically important?Required	Month-21/24 between-arm P values are original significant results. The original statement that no prespecified clinically important minimum BCVA letter difference was identified is preserved. Statistical difference does not automatically establish clinical importance or daily-life benefit. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. A prespecified importance threshold, between-arm CI/exclusion of important effects and patient-related validation remain unverified. Existing content review remains incomplete.	Distinguishing prespecified minimum important BCVA difference, precision and patient function	Proposal: Link statistical significance/precision to importance. No new research, calculation or trial was performed.
13	Partly verified	Full text not readStored summary read	N13 · Efficacy comparison and presentation of stored materialIs loss of more than 5 letters a minimum-important-benefit threshold?Required	The original safety/vision-loss wording records month-24 loss of more than 5 BCVA letters in 7% versus 18%. This is not converted into a prespecified minimum important improvement difference or responder/daily-function percentage. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Loss definition, eye/person denominators, CI/prespecified hierarchy and relationship to an important-improvement threshold remain unverified. Existing content review remains incomplete.	Distinguishing month-24 loss of >5 letters in 7%/18% from a benefit threshold	Proposal: Separate the loss threshold from importance of improvement. No new research, calculation or trial was performed.
14	Partly verified	Full text not readStored summary read	N14 · Efficacy comparison and presentation of stored materialHow were bilateral eyes and repeated BCVA in the same participant analyzed?Required	The original trial's month-13/21/24 data from 100 participants and 148 eyes may involve shared participants/eyes and repeated time points. Eyes/time points are not counted as new independent observations or trials; only original LS mean wording is preserved. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Correlation/clustering, repeated-measures models, covariates, model assumptions and missing-data imputation remain unverified. Existing content review remains incomplete.	Within-person bilateral/repeated observations, centers and LS mean model definitions	Proposal: Document eye/person/time analysis structure. No new research, calculation or trial was performed.
15	Partly verified	Full text not readStored summary read	N15 · Efficacy comparison and presentation of stored materialIs low-fluence sham the same as an unexposed comparator?Required	The original sham was also an active comparator delivering low-fluence light. Results are not repurposed as effects versus no treatment, every other light therapy or an absolute standalone device effect. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Exact sham fluence/exposure, masking, common treatments and comparator physiological effects remain unverified. Existing content review remains incomplete.	Active low-fluence sham and the scope of the additional-effect comparison	Proposal: Document the active-comparator comparison definition. No new research, calculation or trial was performed.
16	Partly verified	Full text not readStored summary read	N16 · Efficacy comparison and presentation of stored materialWere masking, environment and learning effects in BCVA measurement verified?Required	The original outcome is ETDRS best-corrected visual-acuity letters, and the double-masked design is preserved. Measurement conditions, learning and assessor influences in repeated chart testing are not arbitrarily established. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Details of refractive correction, lighting, test distance, assessors/masking and repeated-test standardization remain unverified. Existing content review remains incomplete.	ETDRS best correction, repeated testing and assessor/condition standardization	Proposal: Document measurement definitions and repeated-test conditions. No new research, calculation or trial was performed.
17	Partly verified	Full text not readStored summary read	N17 · Efficacy comparison and presentation of stored materialDoes eye-specific BCVA answer questions about daily visual function and independence?Required	The original manuscript describes chart letters as a surrogate for daily function. It is not extended to reading, driving, independence or blindness prevention; the related subclaim is graded ? and described as not primary and unestablished. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Prespecified daily-function measures, denominators, between-arm values/CI and clinical-event outcomes remain unverified. Existing content review remains incomplete.	Distinguishing the surrogate, patient function, blindness and independence outcomes	Proposal: Provide separate materials for surrogate and direct functional outcomes. No new research, calculation or trial was performed.
18	Partly verified	Full text not readStored summary read	N18 · Efficacy comparison and presentation of stored materialAt what reporting level was exploratory vision-related quality of life examined?Required	The original Korean counterview states that the paper also explored vision-related quality of life, while BCVA was primary. Exploration is not promoted to confirmed functional benefit or a prespecified primary outcome. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Measures, time points/hierarchy, values/CI/P, denominators and multiplicity remain unverified. Existing content review remains incomplete.	BCVA primary time points, exploratory quality of life and original-language scope	Proposal: Link exploratory functional outcomes to BCVA primary time points. No new research, calculation or trial was performed.
19	Partly verified	Full text not readStored summary read	N19 · Efficacy comparison and presentation of stored materialAre month-24 results during repeated treatment persistent effects after treatment ends?Required	Original repeated-treatment conditions and month-24 BCVA reporting are preserved. These are not converted into persistence after treatment, lifetime vision/blindness prevention or efficacy under other repetition schedules. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Actual repeated exposure, follow-up after observation ends/without exposure and outcomes under other schedules remain unverified. Existing content review remains incomplete.	Distinguishing repeated exposure every 4 months, observation period and unexposed follow-up	Proposal: Link persistence during/after exposure to period-specific materials. No new research, calculation or trial was performed.
20	Partly verified	Full text not readStored summary read	N20 · Efficacy comparison and presentation of stored materialAre the same report and related table kept separate from independent replication?Required	LIGHTSITE III's 100 participants and 148 eyes from one existing report/bibliography are shared by the BCVA and daily-function tables. The same eyes/people, time points, outcomes and two tables are not added as new independent trials or participants. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Unique trial, participant and independent-replication totals have not been confirmed and remain unrecorded. Existing content review remains incomplete.	LIGHTSITE III, shared patients/eyes/time points and the two questions	Proposal: Record relationships among shared trials/patients/eyes. No new research, calculation or trial was performed.
21	Partly verified	Full text not readStored summary read	N21 · Efficacy comparison and presentation of stored materialWhat were LumiThera and NEI support and the five authors' relationships?Required	Original support was LumiThera plus NEI1R43EY025508-03. S.E.Tedford, C.L.Croissant, M.R.Munk, R.Rückert and C.E.Tedford were the 5 authors described as employees or consultants. Employment versus consulting is not newly assigned to each person. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Individual relationships, study/analysis/writing roles, contracts/COI and other support details remain unread externally. Existing content review remains incomplete.	Separating funding, employment/consulting, individual roles and COI	Proposal: Document funding and each person's actual role. No new research, calculation or trial was performed.
22	Partly verified	Full text not readStored summary read	N22 · Efficacy comparison and presentation of stored materialWere free device provision, analysis authority and manuscript involvement verified?Required	Original manufacturer support, 5 employee/consultant authors and parent I0/B2 are preserved as history. This wording alone does not establish free devices, all data rights or individual authors' COI. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Free products/devices, data access/analysis/publication authority and individual COI remain unverified. Existing content review remains incomplete.	Separate information on company funding, device provision, author roles and COI	Proposal: Provide separate materials on support types and actual decision rights. No new research, calculation or trial was performed.
23	Partly verified	Full text not readStored summary read	N23 · Efficacy comparison and presentation of stored materialWhat is known about the registration identifier and actual prespecified plans?Required	Original NCT04065490 is preserved, linked to wording on prespecified month-13/21 BCVA time points. The identifier alone does not establish reading of registration/amendment history, protocol or SAP. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Original registration, plans, amendments/multiplicity and prespecification of a minimum important difference remain unread. Existing content review remains incomplete.	NCT04065490 identifier, month-13/21 plans and amendment history	Proposal: Link registration versions to time-point/outcome plans. No new research, calculation or trial was performed.
24	Partly verified	Full text not readStored summary read	N24 · Harm-information gaps supplementing the efficacy tableWhat denominators and periods apply to ocular AE and serious ocular AE?Supplementary	Original ocular AE rates of 25.8% versus 25.5% and serious ocular AE rates of 7.5% versus 5.5% are preserved. Eye, person or event counts, between-arm differences and risk ratios are not newly calculated. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Safety denominators, collection definitions, arms/time points, repeated events and missingness/CI remain unverified. Existing content review remains incomplete.	Events and person/eye units for 25.8/25.5% and 7.5/5.5%	Proposal: Link event and denominator materials for each ocular harm. No new research, calculation or trial was performed.
25	Partly verified	Full text not readStored summary read	N25 · Harm-information gaps supplementing the efficacy tableDoes no reported treatment-related serious-event or phototoxicity signal establish overall safety?Supplementary	The original manuscript states that treatment-related serious adverse events and phototoxicity signals were not reported. This is not converted into zero events, zero risk, long-term/other-device safety or a use recommendation. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Collection/relatedness adjudication, follow-up losses, long-term/vulnerable-population harms and precision remain unverified. Existing content review remains incomplete.	Original absence of a signal, relatedness adjudication, exposure/follow-up and long-term harms	Proposal: Separate reported signals from unverified harms. No new research, calculation or trial was performed.
26	Partly verified	Full text not readStored summary read	N26 · Efficacy comparison and presentation of stored materialCan results be extended to other devices, diseases and acuity conditions?Required	The selected question is BCVA with original Valeda in dry AMD versus sham. It is not extended to other light devices, diseases/stages, daily function, blindness prevention or independence certification. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Direct comparisons/clinical outcomes and independent replication under other conditions remain unverified. Existing content review remains incomplete.	Valeda in dry AMD, the studied conditions and direct materials outside that scope	Proposal: Record condition-specific questions and direct-evidence gaps. No new research, calculation or trial was performed.
27	Partly verified	Full text not readStored summary read	N27 · Efficacy comparison and presentation of stored materialAt what level were the preserved summary and external papers/plans read?Required	The complete preserved summary was read for production and labeled summary read. The original PMID41791029 URL is preserved; external papers, registration/plans and COI remain unread. Historical review statements or URLs do not upgrade current reading status. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. External clinical-material access, paper comparison and external-link/click checks were not performed in the recorded work. Existing content review remains incomplete.	Distinguishing the preserved summary, original URLs and actual reading of registration/protocol/SAP/COI	Proposal: Record acquisition/reading status and versions by material. No new research, calculation or trial was performed.
28	Partly verified	Full text not readStored summary read	N28 · Efficacy comparison and presentation of stored materialHow are Korean/English texts, dates, original axes/empty values and corrections preserved?Required	The complete original summary's Korean/English texts, parent C50/Caution, unrecorded/false precision indicators, empty corrections/deliberation and 2026-08-26 are preserved. Subclaim C grade/note are distinguished from absent score/status/axes; the recorded work did not create a new English verdict translation, correction or reassessment. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. At original authoring, external updating, verdict-manuscript translation, clinical-original review and added corrections were not performed. Existing content review remains incomplete.	Subclaim C and parent C50, Korean/English texts, 2026-08-26 and unrecorded/false/empty values	Proposal: Link original versions/dates to production content. No new research, calculation or trial was performed.
29	Partly verified	Full text not readStored summary read	N29 · Efficacy comparison and presentation of stored materialDoes condition freezing/application and table production establish completed content review?Required	Condition preservation, freezing, application, case production and content review are separate records. Existing content review remains incomplete; counts of rows, reports and materials are not unique clinical-trial or participant totals. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Existing content review remains incomplete. The original authoring record did not perform self-review, tests, screen or link checks. Existing content review remains incomplete.	Separate condition preservation/freezing/application, case production and incomplete content review	Proposal: Record condition/production versions and user-change history. No new research, calculation or trial was performed.

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29 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: LIGHTSITE III: 100 people and 148 eyes with dry AMD at 10 US centers; exact baseline/eligibility conditions unverified
Ingredient, formulation and route: Original Valeda multiwavelength, repeated study exposure; not device-use instructions
Dose: Not recorded
Comparator: Active sham delivering low-fluence light; not repurposed as an untreated comparator
Measured outcome: ETDRS best-corrected visual-acuity letter change; prespecified months 13/21 distinguished from month-24 reporting
Duration: Prespecified BCVA time points at months 13 and 21; original month-21/24 values and observations during/after repeated exposure distinguished
Questions outside this scope: Repurposing BCVA letters, statistical P or the original approximate 3.8-letter difference as direct effects on reading, driving, independent living or blindness prevention; Promoting exploratory quality-of-life wording to a prespecified primary outcome, confirmed function or quantitative values; Changing prespecified month-13/21 BCVA time points to month 24 or daily-function primary time points, or filling absent month-13 values with another time point; Repurposing each arm's month-21 CI as a between-arm-difference CI, a month-24 CI or a daily-function interval; Calculating new differences, rates, effects, CI or hypothetical values from original +6.2/+2.4, +5.6/+1.3, approximate 3.8, CI or P; Filling an unverified prespecified minimum important letter difference with a new threshold, or repurposing >5-letter loss in 7%/18% as important benefit or daily-function response rates; Recalculating 100 people and 148 eyes, or 20 discontinuations/original 20% attrition, into arm/time-specific analysis denominators, daily-function response denominators or unique participants; Adding bilateral eyes, repeated time points/arms, related tables/outcomes or one report as new independent trials or participants; Repurposing comparison with active low-fluence sham as efficacy versus no treatment or other devices; Converting manufacturer/NEI support and five employee-or-consultant authors into free-device provision, individual roles, complete COI or independence certification; Repurposing original ocular AE/serious AE and absence of reported related serious events/phototoxicity as overall safety, zero risk or other-device/long-term safety; Extending original month-24 results during repeated exposure to effects after treatment ends, lifetime effects or clinical efficacy under other conditions/devices; Inheriting parent C50/axes, historical cross-validation or original-material review wording as subclaim ?/score, current content review or external reading; New clinical research, numerical calculations, hypothetical quantitative examples, new effects/CI/grades/independence certification, or treatment/device-setting/administration/daily-rehabilitation/driving/treatment-replacement instructions

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

S01 · LIGHTSITE III month-24 report

PubMed

Material type: Double-masked, sham-controlled multicenter randomized trial
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: Month 21: +6.2 (95% CI 4.2~8.2) versus +2.4 (−0.1~4.9), P=.0036; month 24: +5.6 versus +1.3, P=.0024. Each arm's CI differs from a between-arm-difference interval; the original counterview's approximate 3.8 letters is preserved only as an existing value. Month-24 >5-letter decline in 7%/18% is a separate loss endpoint. No new difference/CI, important difference, daily-life benefit or denominator is calculated.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: S01 LIGHTSITE III month-24 report/Jaffe 2026 PMID41791029 is the same report of a 2:1 randomized, double-masked active-sham comparison at 10 US centers involving 100 people and 148 eyes. Prespecified month-13/21 BCVA, original month-21/24 values and 20 discontinuations are distinguished. This table and its related table, patients/eyes/arms, repeated time points and outcomes are not added as new independent trials or participants. Unique clinical totals are unrecorded; counts of material/report entries are not clinical independence totals.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Stored file	Stored summary	Summary read	Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review.
External paper	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Protocol	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis plan	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

Report counts versus independent study counts

S01 LIGHTSITE III month-24 report/Jaffe 2026 PMID41791029 is the same report of a 2:1 randomized, double-masked active-sham comparison at 10 US centers involving 100 people and 148 eyes. Prespecified month-13/21 BCVA, original month-21/24 values and 20 discontinuations are distinguished. This table and its related table, patients/eyes/arms, repeated time points and outcomes are not added as new independent trials or participants. Unique clinical totals are unrecorded; counts of material/report entries are not clinical independence totals.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · How does the selected BCVA question differ from the parent verdict?

Required materials and conditions: Separating subclaim C grade, note and absent values from parent C50, axes and original verdict
Conditions for verification: Original materials and analysis scope covering Separating subclaim C grade, note and absent values from parent C50, axes and original verdict must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes Separating subclaim C grade, note and absent values from parent C50, axes and original verdict to link the materials needed for the selected question with those currently available.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

N02 · What were LIGHTSITE III's actual population and recruitment conditions?

Required materials and conditions: Ten US centers, dry AMD, baseline acuity/stage and selection criteria
Conditions for verification: Original materials and analysis scope covering Ten US centers, dry AMD, baseline acuity/stage and selection criteria must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes Ten US centers, dry AMD, baseline acuity/stage and selection criteria to link the materials needed for the selected question with those currently available.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design

N03 · What were the historical Valeda and sham study exposures?

Required materials and conditions: Distinguishing original wavelengths, sessions/duration, repetition and comparator
Conditions for verification: Original materials and analysis scope covering Distinguishing original wavelengths, sessions/duration, repetition and comparator must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes Distinguishing original wavelengths, sessions/duration, repetition and comparator to link the materials needed for the selected question with those currently available.
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

N04 · What units and procedures underlie 2:1 randomization and double masking?

Required materials and conditions: 100 participants and 148 eyes, allocation unit, concealment and bilateral-eye/center relationships
Conditions for verification: Original materials and analysis scope covering 100 participants and 148 eyes, allocation unit, concealment and bilateral-eye/center relationships must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes 100 participants and 148 eyes, allocation unit, concealment and bilateral-eye/center relationships to link the materials needed for the selected question with those currently available.
Referenced methods: M08 §8.1–8.2.3; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design

N05 · What denominators do 100 participants and 148 eyes represent?

Required materials and conditions: Distinguishing people, eyes, bilateral participation, analysis populations and repeated time points
Conditions for verification: Original materials and analysis scope covering Distinguishing people, eyes, bilateral participation, analysis populations and repeated time points must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes Distinguishing people, eyes, bilateral participation, analysis populations and repeated time points to link the materials needed for the selected question with those currently available.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

N06 · What observation losses do 20 discontinuations and original 20% attrition represent?

Required materials and conditions: Discontinued participants, time points/arms/eyes and missingness
Conditions for verification: Original materials and analysis scope covering Discontinued participants, time points/arms/eyes and missingness must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes Discontinued participants, time points/arms/eyes and missingness to link the materials needed for the selected question with those currently available.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

N07 · How do prespecified primary time points at months 13 and 21 differ from the month-24 report?

Required materials and conditions: Original prespecified BCVA time points, reporting time points, outcome hierarchy and multiplicity
Conditions for verification: Original materials and analysis scope covering Original prespecified BCVA time points, reporting time points, outcome hierarchy and multiplicity must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes Original prespecified BCVA time points, reporting time points, outcome hierarchy and multiplicity to link the materials needed for the selected question with those currently available.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design; M08 Table 8.2.a, M04 §4.6.3; own application

N08 · What were month-21 PBM and sham changes and intervals?

Required materials and conditions: Original LS BCVA changes +6.2/+2.4, arm-specific CI and between-arm P
Conditions for verification: Original materials and analysis scope covering Original LS BCVA changes +6.2/+2.4, arm-specific CI and between-arm P must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes Original LS BCVA changes +6.2/+2.4, arm-specific CI and between-arm P to link the materials needed for the selected question with those currently available.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application

N09 · Is the approximate 3.8-letter between-arm difference an original manuscript value?

Required materials and conditions: Distinguishing the original approximate 3.8 LS difference from arm changes and importance
Conditions for verification: Original materials and analysis scope covering Distinguishing the original approximate 3.8 LS difference from arm changes and importance must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes Distinguishing the original approximate 3.8 LS difference from arm changes and importance to link the materials needed for the selected question with those currently available.
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application

N10 · Which analysis produced month-24 changes and P?

Required materials and conditions: +5.6/+1.3, P=.0024 and time-point/denominator/hierarchy
Conditions for verification: Original materials and analysis scope covering +5.6/+1.3, P=.0024 and time-point/denominator/hierarchy must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes +5.6/+1.3, P=.0024 and time-point/denominator/hierarchy to link the materials needed for the selected question with those currently available.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design; M15 §15.3.1–15.3.3; own application; M08 Table 8.2.a, M04 §4.6.3; own application

N11 · Does this summary contain results for the month-13 primary time point?

Required materials and conditions: The original month-13 primary time point and gaps in actual values/denominators
Conditions for verification: Original materials and analysis scope covering The original month-13 primary time point and gaps in actual values/denominators must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes The original month-13 primary time point and gaps in actual values/denominators to link the materials needed for the selected question with those currently available.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design; M08 Table 8.2.a, M04 §4.6.3; own application

N12 · Is a statistically significant letter difference clinically important?

Required materials and conditions: Distinguishing prespecified minimum important BCVA difference, precision and patient function
Conditions for verification: Original materials and analysis scope covering Distinguishing prespecified minimum important BCVA difference, precision and patient function must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes Distinguishing prespecified minimum important BCVA difference, precision and patient function to link the materials needed for the selected question with those currently available.
Referenced methods: M15 §15.3.1–15.3.3; Chamgap's own application; M03 §3.2.4; Chamgap's own limits on extension

N13 · Is loss of more than 5 letters a minimum-important-benefit threshold?

Required materials and conditions: Distinguishing month-24 loss of >5 letters in 7%/18% from a benefit threshold
Conditions for verification: Original materials and analysis scope covering Distinguishing month-24 loss of >5 letters in 7%/18% from a benefit threshold must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes Distinguishing month-24 loss of >5 letters in 7%/18% from a benefit threshold to link the materials needed for the selected question with those currently available.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design; M15 §15.3.1–15.3.3; own application; M08 Table 8.2.a, M04 §4.6.3; own application

N14 · How were bilateral eyes and repeated BCVA in the same participant analyzed?

Required materials and conditions: Within-person bilateral/repeated observations, centers and LS mean model definitions
Conditions for verification: Original materials and analysis scope covering Within-person bilateral/repeated observations, centers and LS mean model definitions must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes Within-person bilateral/repeated observations, centers and LS mean model definitions to link the materials needed for the selected question with those currently available.
Referenced methods: M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.

N15 · Is low-fluence sham the same as an unexposed comparator?

Required materials and conditions: Active low-fluence sham and the scope of the additional-effect comparison
Conditions for verification: Original materials and analysis scope covering Active low-fluence sham and the scope of the additional-effect comparison must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes Active low-fluence sham and the scope of the additional-effect comparison to link the materials needed for the selected question with those currently available.
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

N16 · Were masking, environment and learning effects in BCVA measurement verified?

Required materials and conditions: ETDRS best correction, repeated testing and assessor/condition standardization
Conditions for verification: Original materials and analysis scope covering ETDRS best correction, repeated testing and assessor/condition standardization must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes ETDRS best correction, repeated testing and assessor/condition standardization to link the materials needed for the selected question with those currently available.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design

N17 · Does eye-specific BCVA answer questions about daily visual function and independence?

Required materials and conditions: Distinguishing the surrogate, patient function, blindness and independence outcomes
Conditions for verification: Original materials and analysis scope covering Distinguishing the surrogate, patient function, blindness and independence outcomes must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes Distinguishing the surrogate, patient function, blindness and independence outcomes to link the materials needed for the selected question with those currently available.
Referenced methods: M03 §3.2.4; own boundary for extrapolation; question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design

N18 · At what reporting level was exploratory vision-related quality of life examined?

Required materials and conditions: BCVA primary time points, exploratory quality of life and original-language scope
Conditions for verification: Original materials and analysis scope covering BCVA primary time points, exploratory quality of life and original-language scope must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes BCVA primary time points, exploratory quality of life and original-language scope to link the materials needed for the selected question with those currently available.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; own application; M03 §3.2.4; own boundary for extrapolation

N19 · Are month-24 results during repeated treatment persistent effects after treatment ends?

Required materials and conditions: Distinguishing repeated exposure every 4 months, observation period and unexposed follow-up
Conditions for verification: Original materials and analysis scope covering Distinguishing repeated exposure every 4 months, observation period and unexposed follow-up must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes Distinguishing repeated exposure every 4 months, observation period and unexposed follow-up to link the materials needed for the selected question with those currently available.
Referenced methods: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design; M19 §19.1.2–19.2.4; own application

N20 · Are the same report and related table kept separate from independent replication?

Required materials and conditions: LIGHTSITE III, shared patients/eyes/time points and the two questions
Conditions for verification: Original materials and analysis scope covering LIGHTSITE III, shared patients/eyes/time points and the two questions must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes LIGHTSITE III, shared patients/eyes/time points and the two questions to link the materials needed for the selected question with those currently available.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

N21 · What were LumiThera and NEI support and the five authors' relationships?

Required materials and conditions: Separating funding, employment/consulting, individual roles and COI
Conditions for verification: Original materials and analysis scope covering Separating funding, employment/consulting, individual roles and COI must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes Separating funding, employment/consulting, individual roles and COI to link the materials needed for the selected question with those currently available.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

N22 · Were free device provision, analysis authority and manuscript involvement verified?

Required materials and conditions: Separate information on company funding, device provision, author roles and COI
Conditions for verification: Original materials and analysis scope covering Separate information on company funding, device provision, author roles and COI must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes Separate information on company funding, device provision, author roles and COI to link the materials needed for the selected question with those currently available.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

N23 · What is known about the registration identifier and actual prespecified plans?

Required materials and conditions: NCT04065490 identifier, month-13/21 plans and amendment history
Conditions for verification: Original materials and analysis scope covering NCT04065490 identifier, month-13/21 plans and amendment history must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes NCT04065490 identifier, month-13/21 plans and amendment history to link the materials needed for the selected question with those currently available.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application

N24 · What denominators and periods apply to ocular AE and serious ocular AE?

Required materials and conditions: Events and person/eye units for 25.8/25.5% and 7.5/5.5%
Conditions for verification: Original materials and analysis scope covering Events and person/eye units for 25.8/25.5% and 7.5/5.5% must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Supplementary
Application exceptions: This supplements gaps in ocular-harm/vision-loss materials for the selected BCVA/daily-function question. Letters/function or original absence-of-report wording are not used to judge overall safety or generate harm rates, device-use/settings or treatment instructions.
Why this condition is needed: This item distinguishes Events and person/eye units for 25.8/25.5% and 7.5/5.5% to link the materials needed for the selected question with those currently available.
Referenced methods: M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; detailed distinctions are internally designed; M19 §19.1.2–19.2.4; internal application

N25 · Does no reported treatment-related serious-event or phototoxicity signal establish overall safety?

Required materials and conditions: Original absence of a signal, relatedness adjudication, exposure/follow-up and long-term harms
Conditions for verification: Original materials and analysis scope covering Original absence of a signal, relatedness adjudication, exposure/follow-up and long-term harms must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Supplementary
Application exceptions: This supplements gaps in ocular-harm/vision-loss materials for the selected BCVA/daily-function question. Letters/function or original absence-of-report wording are not used to judge overall safety or generate harm rates, device-use/settings or treatment instructions.
Why this condition is needed: This item distinguishes Original absence of a signal, relatedness adjudication, exposure/follow-up and long-term harms to link the materials needed for the selected question with those currently available.
Referenced methods: M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; detailed distinctions are internally designed; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4; internal application; Chamgap's own interpretation boundary. Refers to M19 principles; no formal causality tool was applied.

N26 · Can results be extended to other devices, diseases and acuity conditions?

Required materials and conditions: Valeda in dry AMD, the studied conditions and direct materials outside that scope
Conditions for verification: Original materials and analysis scope covering Valeda in dry AMD, the studied conditions and direct materials outside that scope must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes Valeda in dry AMD, the studied conditions and direct materials outside that scope to link the materials needed for the selected question with those currently available.
Referenced methods: Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design; M03 §3.2.1; detailed population conditions are our own design; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptation are our own design; M04 §4.6.1–4.6.2, M15 §15.3.1; own application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design

N27 · At what level were the preserved summary and external papers/plans read?

Required materials and conditions: Distinguishing the preserved summary, original URLs and actual reading of registration/protocol/SAP/COI
Conditions for verification: Original materials and analysis scope covering Distinguishing the preserved summary, original URLs and actual reading of registration/protocol/SAP/COI must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes Distinguishing the preserved summary, original URLs and actual reading of registration/protocol/SAP/COI to link the materials needed for the selected question with those currently available.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

N28 · How are Korean/English texts, dates, original axes/empty values and corrections preserved?

Required materials and conditions: Subclaim C and parent C50, Korean/English texts, 2026-08-26 and unrecorded/false/empty values
Conditions for verification: Original materials and analysis scope covering Subclaim C and parent C50, Korean/English texts, 2026-08-26 and unrecorded/false/empty values must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes Subclaim C and parent C50, Korean/English texts, 2026-08-26 and unrecorded/false/empty values to link the materials needed for the selected question with those currently available.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

N29 · Does condition freezing/application and table production establish completed content review?

Required materials and conditions: Separate condition preservation/freezing/application, case production and incomplete content review
Conditions for verification: Original materials and analysis scope covering Separate condition preservation/freezing/application, case production and incomplete content review must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This item distinguishes Separate condition preservation/freezing/application, case production and incomplete content review to link the materials needed for the selected question with those currently available.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

What the statuses mean

Met: Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.
Partly verified: Some information in the stored summary is linked into the table. External comparison/content review is not complete.
Unverified: The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.
Review incomplete: Existing content review incomplete.
Not reported: Not reported within the stored material actually read; not extended to the entire primary paper.
Inaccessible: Means an actual access failure. Access not attempted here is not assigned this state.
Not applicable: Not used as a substitute for an evidence gap.
Conflicting data: Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.
Insufficient evidence for the conditions: Marks a gap in additional material required by the selected conditions; not a new efficacy grade.

Change history

2026-10-10 · Public page/material version 1.0

Public pages and materials were created from the existing 29 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · How does the selected BCVA question differ from the parent verdict?

Current findings: The selected existing question is improved ETDRS best-corrected visual-acuity letters, with original C grade and note but no score, status or axes. Parent C50, Caution and original axes such as S/R1/I0/E+/B2 remain parent context.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Absent subclaim score, status and axes are not filled with parent values, and no new grade is written. Existing content review remains incomplete.
Reason for missing information: Absent subclaim score, status and axes are not filled with parent values, and no new grade is written.
Required materials and conditions: Separating subclaim C grade, note and absent values from parent C50, axes and original verdict
Materials to obtain first: Additional selected materials or user comments
Further research: Proposal: Separate sources for the original question and verdict context. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering Separating subclaim C grade, note and absent values from parent C50, axes and original verdict must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes Separating subclaim C grade, note and absent values from parent C50, axes and original verdict to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources S01

N02 · What were LIGHTSITE III's actual population and recruitment conditions?

Current findings: The original trial included 100 people with dry age-related macular degeneration at 10 US centers. Results are not extended to wet AMD, other acuity levels or stages, or other devices.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Exact stage, baseline BCVA, age/comorbidities, selection/exclusions and representativeness remain unverified. Existing content review remains incomplete.
Reason for missing information: Exact stage, baseline BCVA, age/comorbidities, selection/exclusions and representativeness remain unverified.
Required materials and conditions: Ten US centers, dry AMD, baseline acuity/stage and selection criteria
Materials to obtain first: Eligibility/exclusions, baseline tables and recruitment flow
Further research: Proposal: Link BCVA materials by population conditions. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering Ten US centers, dry AMD, baseline acuity/stage and selection criteria must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes Ten US centers, dry AMD, baseline acuity/stage and selection criteria to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design

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N03 · What were the historical Valeda and sham study exposures?

Current findings: Valeda study conditions used 590, 660 and 850 nm light, with 9 sessions over 3~5 weeks repeated every 4 months. The sham was an active comparator delivering low-fluence light. These are not converted into device-use, setting or administration instructions.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Actual light dose, arm-specific exposure/adherence, device standardization, stopping/changes and concomitant-treatment details remain unverified. Existing content review remains incomplete.
Reason for missing information: Actual light dose, arm-specific exposure/adherence, device standardization, stopping/changes and concomitant-treatment details remain unverified.
Required materials and conditions: Distinguishing original wavelengths, sessions/duration, repetition and comparator
Materials to obtain first: Exposure/adherence, comparator/device records and protocol
Further research: Proposal: Distinguish device study conditions from actual exposure. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering Distinguishing original wavelengths, sessions/duration, repetition and comparator must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes Distinguishing original wavelengths, sessions/duration, repetition and comparator to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

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N04 · What units and procedures underlie 2:1 randomization and double masking?

Current findings: LIGHTSITE III is described as a double-masked sham-controlled trial randomizing 100 participants and 148 eyes 2:1. Arm-specific people/eye counts and allocation units are not newly calculated.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Person/eye allocation unit, same-arm handling of bilateral eyes, sequence generation/concealment and maintenance of masking remain unverified. Existing content review remains incomplete.
Reason for missing information: Person/eye allocation unit, same-arm handling of bilateral eyes, sequence generation/concealment and maintenance of masking remain unverified.
Required materials and conditions: 100 participants and 148 eyes, allocation unit, concealment and bilateral-eye/center relationships
Materials to obtain first: Allocation/masking records, arm-specific people/eye tables and protocol
Further research: Proposal: Document allocation units and arm/center structure. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering 100 participants and 148 eyes, allocation unit, concealment and bilateral-eye/center relationships must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes 100 participants and 148 eyes, allocation unit, concealment and bilateral-eye/center relationships to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 §8.1–8.2.3; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design

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N05 · What denominators do 100 participants and 148 eyes represent?

Current findings: 100 participants and 148 eyes are the original randomized denominators. People are not converted into eyes, 148 independent participants or the analyzed eyes at every time point.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. People, eyes and observed/analyzed denominators by arm/time point, and handling of bilateral-eye correlation, remain unverified. Existing content review remains incomplete.
Reason for missing information: People, eyes and observed/analyzed denominators by arm/time point, and handling of bilateral-eye correlation, remain unverified.
Required materials and conditions: Distinguishing people, eyes, bilateral participation, analysis populations and repeated time points
Materials to obtain first: People/eye flow and analysis-population tables by arm/time point
Further research: Proposal: Link participant and eye denominators. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering Distinguishing people, eyes, bilateral participation, analysis populations and repeated time points must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes Distinguishing people, eyes, bilateral participation, analysis populations and repeated time points to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

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N06 · What observation losses do 20 discontinuations and original 20% attrition represent?

Current findings: 20 of 100 participants discontinued, and the original verdict describes 20% attrition. No remaining participant/eye counts, time-specific attrition rates or discontinuation reasons are calculated or filled in.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Discontinuations, eye counts, reasons, missing outcomes and analysis/imputation methods by arm/time point remain unverified. Existing content review remains incomplete.
Reason for missing information: Discontinuations, eye counts, reasons, missing outcomes and analysis/imputation methods by arm/time point remain unverified.
Required materials and conditions: Discontinued participants, time points/arms/eyes and missingness
Materials to obtain first: Participant flow, discontinuations by arm/time point and missing-data handling
Further research: Proposal: Link discontinued participants/eyes to analysis data. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering Discontinued participants, time points/arms/eyes and missingness must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes Discontinued participants, time points/arms/eyes and missingness to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

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N07 · How do prespecified primary time points at months 13 and 21 differ from the month-24 report?

Current findings: The original wording identifies months 13 and 21 as prespecified primary BCVA time points. Month-21 and month-24 BCVA values are preserved, without promoting month 24 to a prespecified primary time point.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Joint hierarchy for months 13/21, prespecified/follow-up status of month 24 and multiple-testing plans remain unverified. Existing content review remains incomplete.
Reason for missing information: Joint hierarchy for months 13/21, prespecified/follow-up status of month 24 and multiple-testing plans remain unverified.
Required materials and conditions: Original prespecified BCVA time points, reporting time points, outcome hierarchy and multiplicity
Materials to obtain first: Registration/protocol/SAP, time-point hierarchy and original result tables
Further research: Proposal: Link prespecified time points to reporting/follow-up time points. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering Original prespecified BCVA time points, reporting time points, outcome hierarchy and multiplicity must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes Original prespecified BCVA time points, reporting time points, outcome hierarchy and multiplicity to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design; M08 Table 8.2.a, M04 §4.6.3; own application

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N08 · What were month-21 PBM and sham changes and intervals?

Current findings: Month 21 PBM +6.2 letters (95% CI 4.2~8.2), sham +2.4 (−.1~4.9), and between-arm P=.0036 are preserved. Arm-specific change CI are not transferred to a between-arm-difference CI.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Analyzed eyes/people by arm, exact between-arm-difference CI, adjustment/missingness and change baseline remain unverified. Existing content review remains incomplete.
Reason for missing information: Analyzed eyes/people by arm, exact between-arm-difference CI, adjustment/missingness and change baseline remain unverified.
Required materials and conditions: Original LS BCVA changes +6.2/+2.4, arm-specific CI and between-arm P
Materials to obtain first: Original LS mean/difference, CI and denominator/model tables
Further research: Proposal: Document within-arm changes and between-arm comparison intervals. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering Original LS BCVA changes +6.2/+2.4, arm-specific CI and between-arm P must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes Original LS BCVA changes +6.2/+2.4, arm-specific CI and between-arm P to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application

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N09 · Is the approximate 3.8-letter between-arm difference an original manuscript value?

Current findings: The original counterview describes an approximate 3.8-letter between-arm LS mean difference at month 21. This original value is preserved; no new difference is calculated from +6.2/+2.4, and no exact CI or clinical-importance threshold is produced.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. The original difference CI, model/rounding, denominators and prespecified importance threshold remain unverified. Existing content review remains incomplete.
Reason for missing information: The original difference CI, model/rounding, denominators and prespecified importance threshold remain unverified.
Required materials and conditions: Distinguishing the original approximate 3.8 LS difference from arm changes and importance
Materials to obtain first: Original between-arm difference table, model and importance definition
Further research: Proposal: Link the original difference to interval and importance definitions. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering Distinguishing the original approximate 3.8 LS difference from arm changes and importance must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes Distinguishing the original approximate 3.8 LS difference from arm changes and importance to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application

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N10 · Which analysis produced month-24 changes and P?

Current findings: Month-24 PBM +5.6 versus sham +1.3 letters, P=.0024, are recorded as in the original materials. They are not pooled with month 21 or used to create a new mean/difference or another trial.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Month-24 arm-specific/between-arm CI, denominators, model/missingness and prespecified hierarchy remain unverified. Existing content review remains incomplete.
Reason for missing information: Month-24 arm-specific/between-arm CI, denominators, model/missingness and prespecified hierarchy remain unverified.
Required materials and conditions: +5.6/+1.3, P=.0024 and time-point/denominator/hierarchy
Materials to obtain first: Original month-24 results/denominators/model and analysis plan
Further research: Proposal: Document time-specific estimands and analysis populations. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering +5.6/+1.3, P=.0024 and time-point/denominator/hierarchy must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes +5.6/+1.3, P=.0024 and time-point/denominator/hierarchy to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design; M15 §15.3.1–15.3.3; own application; M08 Table 8.2.a, M04 §4.6.3; own application

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N11 · Does this summary contain results for the month-13 primary time point?

Current findings: The original endpoint is BCVA change at months 13 and 21, but this preserved summary's quantitative reports concern months 21 and 24. Month-13 values, CI or P are not filled with values from other time points.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Required information is unverified in the preserved summary. Month-13 BCVA values, denominators, analysis/missingness and reporting hierarchy remain unverified in the preserved summary. Existing content review remains incomplete.
Reason for missing information: Month-13 BCVA values, denominators, analysis/missingness and reporting hierarchy remain unverified in the preserved summary.
Required materials and conditions: The original month-13 primary time point and gaps in actual values/denominators
Materials to obtain first: Original month-13 result table and time-specific plans
Further research: Proposal: Link results and omissions at each prespecified time point. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering The original month-13 primary time point and gaps in actual values/denominators must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes The original month-13 primary time point and gaps in actual values/denominators to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design; M08 Table 8.2.a, M04 §4.6.3; own application

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N12 · Is a statistically significant letter difference clinically important?

Current findings: Month-21/24 between-arm P values are original significant results. The original statement that no prespecified clinically important minimum BCVA letter difference was identified is preserved. Statistical difference does not automatically establish clinical importance or daily-life benefit.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. A prespecified importance threshold, between-arm CI/exclusion of important effects and patient-related validation remain unverified. Existing content review remains incomplete.
Reason for missing information: A prespecified importance threshold, between-arm CI/exclusion of important effects and patient-related validation remain unverified.
Required materials and conditions: Distinguishing prespecified minimum important BCVA difference, precision and patient function
Materials to obtain first: Prespecified threshold definition, between-arm intervals and patient-related evidence
Further research: Proposal: Link statistical significance/precision to importance. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering Distinguishing prespecified minimum important BCVA difference, precision and patient function must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes Distinguishing prespecified minimum important BCVA difference, precision and patient function to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M15 §15.3.1–15.3.3; Chamgap's own application; M03 §3.2.4; Chamgap's own limits on extension

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N13 · Is loss of more than 5 letters a minimum-important-benefit threshold?

Current findings: The original safety/vision-loss wording records month-24 loss of more than 5 BCVA letters in 7% versus 18%. This is not converted into a prespecified minimum important improvement difference or responder/daily-function percentage.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Loss definition, eye/person denominators, CI/prespecified hierarchy and relationship to an important-improvement threshold remain unverified. Existing content review remains incomplete.
Reason for missing information: Loss definition, eye/person denominators, CI/prespecified hierarchy and relationship to an important-improvement threshold remain unverified.
Required materials and conditions: Distinguishing month-24 loss of >5 letters in 7%/18% from a benefit threshold
Materials to obtain first: Original loss-endpoint table, denominators, plans and threshold definition
Further research: Proposal: Separate the loss threshold from importance of improvement. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering Distinguishing month-24 loss of >5 letters in 7%/18% from a benefit threshold must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes Distinguishing month-24 loss of >5 letters in 7%/18% from a benefit threshold to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design; M15 §15.3.1–15.3.3; own application; M08 Table 8.2.a, M04 §4.6.3; own application

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N14 · How were bilateral eyes and repeated BCVA in the same participant analyzed?

Current findings: The original trial's month-13/21/24 data from 100 participants and 148 eyes may involve shared participants/eyes and repeated time points. Eyes/time points are not counted as new independent observations or trials; only original LS mean wording is preserved.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Correlation/clustering, repeated-measures models, covariates, model assumptions and missing-data imputation remain unverified. Existing content review remains incomplete.
Reason for missing information: Correlation/clustering, repeated-measures models, covariates, model assumptions and missing-data imputation remain unverified.
Required materials and conditions: Within-person bilateral/repeated observations, centers and LS mean model definitions
Materials to obtain first: SAP, repeated/bilateral-eye models and denominator/covariate tables
Further research: Proposal: Document eye/person/time analysis structure. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering Within-person bilateral/repeated observations, centers and LS mean model definitions must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes Within-person bilateral/repeated observations, centers and LS mean model definitions to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.

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N15 · Is low-fluence sham the same as an unexposed comparator?

Current findings: The original sham was also an active comparator delivering low-fluence light. Results are not repurposed as effects versus no treatment, every other light therapy or an absolute standalone device effect.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Exact sham fluence/exposure, masking, common treatments and comparator physiological effects remain unverified. Existing content review remains incomplete.
Reason for missing information: Exact sham fluence/exposure, masking, common treatments and comparator physiological effects remain unverified.
Required materials and conditions: Active low-fluence sham and the scope of the additional-effect comparison
Materials to obtain first: Both arms' exposure/concomitant treatment, comparator definition and protocol
Further research: Proposal: Document the active-comparator comparison definition. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering Active low-fluence sham and the scope of the additional-effect comparison must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes Active low-fluence sham and the scope of the additional-effect comparison to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

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N16 · Were masking, environment and learning effects in BCVA measurement verified?

Current findings: The original outcome is ETDRS best-corrected visual-acuity letters, and the double-masked design is preserved. Measurement conditions, learning and assessor influences in repeated chart testing are not arbitrarily established.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Details of refractive correction, lighting, test distance, assessors/masking and repeated-test standardization remain unverified. Existing content review remains incomplete.
Reason for missing information: Details of refractive correction, lighting, test distance, assessors/masking and repeated-test standardization remain unverified.
Required materials and conditions: ETDRS best correction, repeated testing and assessor/condition standardization
Materials to obtain first: BCVA measurement instructions, masking and original test data
Further research: Proposal: Document measurement definitions and repeated-test conditions. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering ETDRS best correction, repeated testing and assessor/condition standardization must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes ETDRS best correction, repeated testing and assessor/condition standardization to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design

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N17 · Does eye-specific BCVA answer questions about daily visual function and independence?

Current findings: The original manuscript describes chart letters as a surrogate for daily function. It is not extended to reading, driving, independence or blindness prevention; the related subclaim is graded ? and described as not primary and unestablished.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Prespecified daily-function measures, denominators, between-arm values/CI and clinical-event outcomes remain unverified. Existing content review remains incomplete.
Reason for missing information: Prespecified daily-function measures, denominators, between-arm values/CI and clinical-event outcomes remain unverified.
Required materials and conditions: Distinguishing the surrogate, patient function, blindness and independence outcomes
Materials to obtain first: Patient-function/clinical-event outcomes and prespecified plans
Further research: Proposal: Provide separate materials for surrogate and direct functional outcomes. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering Distinguishing the surrogate, patient function, blindness and independence outcomes must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes Distinguishing the surrogate, patient function, blindness and independence outcomes to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4; own boundary for extrapolation; question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design

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N18 · At what reporting level was exploratory vision-related quality of life examined?

Current findings: The original Korean counterview states that the paper also explored vision-related quality of life, while BCVA was primary. Exploration is not promoted to confirmed functional benefit or a prespecified primary outcome.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Measures, time points/hierarchy, values/CI/P, denominators and multiplicity remain unverified. Existing content review remains incomplete.
Reason for missing information: Measures, time points/hierarchy, values/CI/P, denominators and multiplicity remain unverified.
Required materials and conditions: BCVA primary time points, exploratory quality of life and original-language scope
Materials to obtain first: Original quality-of-life tables, measures and prespecified plans
Further research: Proposal: Link exploratory functional outcomes to BCVA primary time points. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering BCVA primary time points, exploratory quality of life and original-language scope must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes BCVA primary time points, exploratory quality of life and original-language scope to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; own application; M03 §3.2.4; own boundary for extrapolation

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N19 · Are month-24 results during repeated treatment persistent effects after treatment ends?

Current findings: Original repeated-treatment conditions and month-24 BCVA reporting are preserved. These are not converted into persistence after treatment, lifetime vision/blindness prevention or efficacy under other repetition schedules.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Actual repeated exposure, follow-up after observation ends/without exposure and outcomes under other schedules remain unverified. Existing content review remains incomplete.
Reason for missing information: Actual repeated exposure, follow-up after observation ends/without exposure and outcomes under other schedules remain unverified.
Required materials and conditions: Distinguishing repeated exposure every 4 months, observation period and unexposed follow-up
Materials to obtain first: Exposure/follow-up endpoints and long-term/unexposed data
Further research: Proposal: Link persistence during/after exposure to period-specific materials. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering Distinguishing repeated exposure every 4 months, observation period and unexposed follow-up must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes Distinguishing repeated exposure every 4 months, observation period and unexposed follow-up to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design; M19 §19.1.2–19.2.4; own application

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N20 · Are the same report and related table kept separate from independent replication?

Current findings: LIGHTSITE III's 100 participants and 148 eyes from one existing report/bibliography are shared by the BCVA and daily-function tables. The same eyes/people, time points, outcomes and two tables are not added as new independent trials or participants.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Unique trial, participant and independent-replication totals have not been confirmed and remain unrecorded. Existing content review remains incomplete.
Reason for missing information: Unique clinical trial, participant and independent replication totals have not been verified and are not recorded.
Required materials and conditions: LIGHTSITE III, shared patients/eyes/time points and the two questions
Materials to obtain first: When relationships among reports/trials/populations and follow-up materials are supplied
Further research: Proposal: Record relationships among shared trials/patients/eyes. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering LIGHTSITE III, shared patients/eyes/time points and the two questions must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes LIGHTSITE III, shared patients/eyes/time points and the two questions to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

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N21 · What were LumiThera and NEI support and the five authors' relationships?

Current findings: Original support was LumiThera plus NEI1R43EY025508-03. S.E.Tedford, C.L.Croissant, M.R.Munk, R.Rückert and C.E.Tedford were the 5 authors described as employees or consultants. Employment versus consulting is not newly assigned to each person.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Individual relationships, study/analysis/writing roles, contracts/COI and other support details remain unread externally. Existing content review remains incomplete.
Reason for missing information: Individual relationships, study/analysis/writing roles, contracts/COI and other support details remain unread externally.
Required materials and conditions: Separating funding, employment/consulting, individual roles and COI
Materials to obtain first: Funding/contribution/author/COI and employment/consulting contract materials
Further research: Proposal: Document funding and each person's actual role. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering Separating funding, employment/consulting, individual roles and COI must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes Separating funding, employment/consulting, individual roles and COI to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

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N22 · Were free device provision, analysis authority and manuscript involvement verified?

Current findings: Original manufacturer support, 5 employee/consultant authors and parent I0/B2 are preserved as history. This wording alone does not establish free devices, all data rights or individual authors' COI.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Free products/devices, data access/analysis/publication authority and individual COI remain unverified. Existing content review remains incomplete.
Reason for missing information: Free products/devices, data access/analysis/publication authority and individual COI remain unverified.
Required materials and conditions: Separate information on company funding, device provision, author roles and COI
Materials to obtain first: Original device-support, data/analysis/publication contracts and contributions/COI
Further research: Proposal: Provide separate materials on support types and actual decision rights. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering Separate information on company funding, device provision, author roles and COI must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes Separate information on company funding, device provision, author roles and COI to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

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N23 · What is known about the registration identifier and actual prespecified plans?

Current findings: Original NCT04065490 is preserved, linked to wording on prespecified month-13/21 BCVA time points. The identifier alone does not establish reading of registration/amendment history, protocol or SAP.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Original registration, plans, amendments/multiplicity and prespecification of a minimum important difference remain unread. Existing content review remains incomplete.
Reason for missing information: Original registration, plans, amendments/multiplicity and prespecification of a minimum important difference remain unread.
Required materials and conditions: NCT04065490 identifier, month-13/21 plans and amendment history
Materials to obtain first: Registration/protocol/SAP copies or user materials
Further research: Proposal: Link registration versions to time-point/outcome plans. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering NCT04065490 identifier, month-13/21 plans and amendment history must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes NCT04065490 identifier, month-13/21 plans and amendment history to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application

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N24 · What denominators and periods apply to ocular AE and serious ocular AE?

Current findings: Original ocular AE rates of 25.8% versus 25.5% and serious ocular AE rates of 7.5% versus 5.5% are preserved. Eye, person or event counts, between-arm differences and risk ratios are not newly calculated.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Safety denominators, collection definitions, arms/time points, repeated events and missingness/CI remain unverified. Existing content review remains incomplete.
Reason for missing information: Safety denominators, collection definitions, arms/time points, repeated events and missingness/CI remain unverified.
Required materials and conditions: Events and person/eye units for 25.8/25.5% and 7.5/5.5%
Materials to obtain first: Safety tables, event definitions/collection and exposure/follow-up/denominators
Further research: Proposal: Link event and denominator materials for each ocular harm. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering Events and person/eye units for 25.8/25.5% and 7.5/5.5% must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes Events and person/eye units for 25.8/25.5% and 7.5/5.5% to link the materials needed for the selected question with those currently available.
Application exceptions: This supplements gaps in ocular-harm/vision-loss materials for the selected BCVA/daily-function question. Letters/function or original absence-of-report wording are not used to judge overall safety or generate harm rates, device-use/settings or treatment instructions.
Referenced methods: M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; detailed distinctions are internally designed; M19 §19.1.2–19.2.4; internal application

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N25 · Does no reported treatment-related serious-event or phototoxicity signal establish overall safety?

Current findings: The original manuscript states that treatment-related serious adverse events and phototoxicity signals were not reported. This is not converted into zero events, zero risk, long-term/other-device safety or a use recommendation.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Collection/relatedness adjudication, follow-up losses, long-term/vulnerable-population harms and precision remain unverified. Existing content review remains incomplete.
Reason for missing information: Collection/relatedness adjudication, follow-up losses, long-term/vulnerable-population harms and precision remain unverified.
Required materials and conditions: Original absence of a signal, relatedness adjudication, exposure/follow-up and long-term harms
Materials to obtain first: Safety collection/adjudication, original tables and long-term follow-up
Further research: Proposal: Separate reported signals from unverified harms. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering Original absence of a signal, relatedness adjudication, exposure/follow-up and long-term harms must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes Original absence of a signal, relatedness adjudication, exposure/follow-up and long-term harms to link the materials needed for the selected question with those currently available.
Application exceptions: This supplements gaps in ocular-harm/vision-loss materials for the selected BCVA/daily-function question. Letters/function or original absence-of-report wording are not used to judge overall safety or generate harm rates, device-use/settings or treatment instructions.
Referenced methods: M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; detailed distinctions are internally designed; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4; internal application; Chamgap's own interpretation boundary. Refers to M19 principles; no formal causality tool was applied.

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N26 · Can results be extended to other devices, diseases and acuity conditions?

Current findings: The selected question is BCVA with original Valeda in dry AMD versus sham. It is not extended to other light devices, diseases/stages, daily function, blindness prevention or independence certification.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Direct comparisons/clinical outcomes and independent replication under other conditions remain unverified. Existing content review remains incomplete.
Reason for missing information: Direct comparisons/clinical outcomes and independent replication under other conditions remain unverified.
Required materials and conditions: Valeda in dry AMD, the studied conditions and direct materials outside that scope
Materials to obtain first: When direct materials for the relevant separate question are supplied
Further research: Proposal: Record condition-specific questions and direct-evidence gaps. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering Valeda in dry AMD, the studied conditions and direct materials outside that scope must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes Valeda in dry AMD, the studied conditions and direct materials outside that scope to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design; M03 §3.2.1; detailed population conditions are our own design; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptation are our own design; M04 §4.6.1–4.6.2, M15 §15.3.1; own application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design

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N27 · At what level were the preserved summary and external papers/plans read?

Current findings: The complete preserved summary was read for production and labeled summary read. The original PMID41791029 URL is preserved; external papers, registration/plans and COI remain unread. Historical review statements or URLs do not upgrade current reading status.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. External clinical-material access, paper comparison and external-link/click checks were not performed in the recorded work. Existing content review remains incomplete.
Reason for missing information: External clinical-material access, paper comparison and external-link/click checks were not performed in the recorded work.
Required materials and conditions: Distinguishing the preserved summary, original URLs and actual reading of registration/protocol/SAP/COI
Materials to obtain first: User-supplied original materials and actual reading records
Further research: Proposal: Record acquisition/reading status and versions by material. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering Distinguishing the preserved summary, original URLs and actual reading of registration/protocol/SAP/COI must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes Distinguishing the preserved summary, original URLs and actual reading of registration/protocol/SAP/COI to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

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N28 · How are Korean/English texts, dates, original axes/empty values and corrections preserved?

Current findings: The complete original summary's Korean/English texts, parent C50/Caution, unrecorded/false precision indicators, empty corrections/deliberation and 2026-08-26 are preserved. Subclaim C grade/note are distinguished from absent score/status/axes; the recorded work did not create a new English verdict translation, correction or reassessment.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. At original authoring, external updating, verdict-manuscript translation, clinical-original review and added corrections were not performed. Existing content review remains incomplete.
Reason for missing information: At original authoring, external updating, verdict-manuscript translation, clinical-original review and added corrections were not performed.
Required materials and conditions: Subclaim C and parent C50, Korean/English texts, 2026-08-26 and unrecorded/false/empty values
Materials to obtain first: Original correction materials or user comments
Further research: Proposal: Link original versions/dates to production content. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering Subclaim C and parent C50, Korean/English texts, 2026-08-26 and unrecorded/false/empty values must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes Subclaim C and parent C50, Korean/English texts, 2026-08-26 and unrecorded/false/empty values to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

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N29 · Does condition freezing/application and table production establish completed content review?

Current findings: Condition preservation, freezing, application, case production and content review are separate records. Existing content review remains incomplete; counts of rows, reports and materials are not unique clinical-trial or participant totals.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Existing content review remains incomplete. The original authoring record did not perform self-review, tests, screen or link checks. Existing content review remains incomplete.
Reason for missing information: Existing content review remains incomplete. The original authoring record did not perform self-review, tests, screen or link checks.
Required materials and conditions: Separate condition preservation/freezing/application, case production and incomplete content review
Materials to obtain first: User review comments and additional materials
Further research: Proposal: Record condition/production versions and user-change history. No new research, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original materials and analysis scope covering Separate condition preservation/freezing/application, case production and incomplete content review must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.
Why this condition is needed: This item distinguishes Separate condition preservation/freezing/application, case production and incomplete content review to link the materials needed for the selected question with those currently available.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

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