Valeda × Improved daily visual function and independence 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 materialWhat are the existing values for the daily visual-function and independence question?Required	The selected existing question is improved daily visual function and independence, with original grade ? and a note that it was not the primary endpoint and remains unestablished. It is separate from the parent's BCVA C50 and original axes; subclaim score, status and axes are absent. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. No new grade, score or effect is assigned to daily function. Existing content review remains incomplete.	Distinguishing subclaim ? grade/note and absent score/status/axes from parent C50	Proposal: Record separate sources for the daily-function question and parent surrogate verdict. No new research, calculation or trial was performed.
2	Unverified	Full text not readStored summary read	N02 · Efficacy comparison and presentation of stored materialWhat direct outcomes are needed for daily visual function and independent living?Required	The original counterview states that improvement of a few chart letters is not the same as improved reading, driving or independent living. Eye-specific BCVA results are not transferred to patients' daily-life outcomes. S01	Required information is unverified in the preserved summary. Definitions, measures, periods, events/denominators and between-arm values for each function/independence outcome remain unverified. Existing content review remains incomplete.	Clear patient-level measurement of reading, driving, daily function and independence	Proposal: Provide separate endpoint materials for direct daily function and independence. No new research, calculation or trial was performed.
3	Partly verified	Full text not readStored summary read	N03 · Efficacy comparison and presentation of stored materialDo statistically different BCVA results establish daily function?Required	Month 21 +6.2 versus +2.4 letters, P=.0036, and month 24 +5.6 versus +1.3, P=.0024, are original BCVA results. They are not converted into daily-function/independence values, risks or differences; original subclaim ? is preserved. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Patient-level surrogate linkage, between-arm function values/CI and clinical importance remain unverified. Existing content review remains incomplete.	Distinguishing surrogates, direct function and between-arm estimands	Proposal: Separate surrogate and direct-outcome materials. No new research, calculation or trial was performed.
4	Unverified	Full text not readStored summary read	N04 · Efficacy comparison and presentation of stored materialAt what reporting level was vision-related quality of life explored?Required	The original Korean counterview states that vision-related quality of life was also explored while BCVA was primary. Exploratory wording is not promoted to prespecified functional confirmation or quality-of-life benefit. S01	Required information is unverified in the preserved summary. Measures/items, time points, denominators, values/CI/P, multiplicity and prespecification remain unverified. Existing content review remains incomplete.	Distinguishing the original Korean exploratory wording, primary time points and functional endpoints/hierarchy	Proposal: Link exploratory quality of life to prespecified primary time points. No new research, calculation or trial was performed.
5	Unverified	Full text not readStored summary read	N05 · Efficacy comparison and presentation of stored materialAre prespecified month-13/21 BCVA and month-24 reporting daily-function time points?Required	The prespecified primary time points at months 13 and 21 concern BCVA change, and month-24 reporting also contains original BCVA values. They are not automatically transferred to daily-function/independence measurements over the same period or to primary functional endpoints. S01	Required information is unverified in the preserved summary. Functional-outcome time points/follow-up, prespecified analysis hierarchy and long-term periods remain unverified. Existing content review remains incomplete.	Time-specific endpoints and actual functional-outcome periods/hierarchy	Proposal: Document periods and hierarchy for each endpoint. No new research, calculation or trial was performed.
6	Unverified	Full text not readStored summary read	N06 · Efficacy comparison and presentation of stored materialWere actual daily-life improvement values for reading and driving provided?Required	The manuscript mentions reading and driving as examples of daily-life outcomes different from BCVA. They are not written as verified activity measurements or improvement percentages. S01	Required information is unverified in the preserved summary. Activity conditions, functional measurement, denominators, follow-up and between-arm results/CI remain unverified. Existing content review remains incomplete.	Distinguishing illustrative activities from measured activity results/denominators	Proposal: Separate activity examples from measured direct results. No new research, calculation or trial was performed.
7	Unverified	Full text not readStored summary read	N07 · Efficacy comparison and presentation of stored materialAre independent living and blindness prevention direct results in these materials?Required	The original advertising interpretation states that chart scores should not be extended to blindness prevention or improved independent living. No new statement is made that independent-living status or blindness events were collected. S01	Required information is unverified in the preserved summary. Direct event definitions, person/time denominators, follow-up/censoring and original between-arm intervals remain unverified. Existing content review remains incomplete.	Distinguishing independence/clinical events from the scope of BCVA	Proposal: Link direct clinical-event and surrogate materials. No new research, calculation or trial was performed.
8	Unverified	Full text not readStored summary read	N08 · Efficacy comparison and presentation of stored materialWhich of 100 participants and 148 eyes is the daily-function denominator?Required	The original randomized denominators of 100 people and 148 eyes refer to people/eyes in the BCVA trial. The 148 eyes are not repurposed as independent-living participants, and each eye/time point is not counted as a new person. S01	Required information is unverified in the preserved summary. Daily-function questionnaire respondents/analyzed people, bilateral-eye/time-point correspondence and arm-specific denominators remain unverified. Existing content review remains incomplete.	Distinguishing person-level function, eye-specific BCVA, bilateral eyes and analysis populations	Proposal: Document eye and patient-function denominators. No new research, calculation or trial was performed.
9	Partly verified	Full text not readStored summary read	N09 · Efficacy comparison and presentation of stored materialHow do 20 discontinuations relate to losses in daily-function data?Required	20 discontinuations among 100 participants and original 20% attrition are trial context. These are not assumed to mean 20 missing daily-function responses or a remaining response count; no new completion proportion is calculated. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Missing functional responses, discontinuation arms/time points/reasons and imputation/follow-up remain unverified. Existing content review remains incomplete.	Discontinued people, eyes/function responses, arms/time points and missingness	Proposal: Link trial discontinuation to losses in functional data. No new research, calculation or trial was performed.
10	Partly verified	Full text not readStored summary read	N10 · Efficacy comparison and presentation of stored materialWhat were the actual population and baseline daily-function status?Required	The original population was 100 people with dry AMD at 10 US centers. Baseline reading, driving, independence, disease stage and acuity conditions are not arbitrarily filled in. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Baseline functional limitations, exact stage/age, inclusion/exclusion and representativeness for other populations remain unverified. Existing content review remains incomplete.	Dry AMD, 10 US centers, baseline vision/function and eligibility	Proposal: Link eligibility conditions to patient function. No new research, calculation or trial was performed.
11	Partly verified	Full text not readStored summary read	N11 · Efficacy comparison and presentation of stored materialWhat are the study-device, repeated-exposure and daily-function comparison terms?Required	Original Valeda multiwavelength, repeated study exposure and active low-fluence sham are preserved. These conditions are not converted into administration instructions for daily-life rehabilitation or independence treatment. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Actual exposure/adherence during function measurement, comparator conditions and concomitant treatment/aids/rehabilitation remain unverified. Existing content review remains incomplete.	Original Valeda, historical repeated treatment, active sham and actual exposure	Proposal: Document device comparison and concomitant exposures. No new research, calculation or trial was performed.
12	Partly verified	Full text not readStored summary read	N12 · Efficacy comparison and presentation of stored materialWere randomization and masking verified for functional-outcome measurement?Required	The original trial was a 2:1 randomized, double-masked sham comparison. This is not inherited as verified functional-scale assessors/response methods, allocation awareness or maintenance of masking. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Allocation unit/concealment, functional-assessment masking/awareness and assessment environment remain unverified. Existing content review remains incomplete.	2:1 allocation, double masking, patient responses, assessors and conditions	Proposal: Link design to functional measurement. No new research, calculation or trial was performed.
13	Unverified	Full text not readStored summary read	N13 · Efficacy comparison and presentation of stored materialWhich estimands and models were used for daily-function analysis?Required	The original approximate 3.8-letter between-arm LS difference concerns month-21 BCVA. It is not repurposed as a quality-of-life/independence scale score, probability or daily-improvement CI. S01	Required information is unverified in the preserved summary. Original functional analysis/adjustment, models/repetition, prespecified contrasts, CI/P and denominators remain unverified. Existing content review remains incomplete.	Patient scales/events, eye/repeated-observation structure, within/between arms and CI	Proposal: Link endpoint-specific estimands and models. No new research, calculation or trial was performed.
14	Unverified	Full text not readStored summary read	N14 · Efficacy comparison and presentation of stored materialDoes an unverified minimum important BCVA difference provide a functional threshold?Required	An original prespecified minimum important BCVA letter difference was not identified. Statistical BCVA differences, a few letters or an unverified prespecified threshold are not used to create daily-function important differences or responder criteria. S01	Required information is unverified in the preserved summary. Prespecified minimum important differences, intervals, response criteria and validation for functional measures remain unverified. Existing content review remains incomplete.	Distinguishing surrogate importance, direct-function importance and statistical differences	Proposal: Provide materials for surrogate and functional importance separately. No new research, calculation or trial was performed.
15	Partly verified	Full text not readStored summary read	N15 · Efficacy comparison and presentation of stored materialDoes month-24 >5-letter loss in 7%/18% mean improved independent living?Required	Original month-24 BCVA loss of more than 5 letters in 7%/18% is a vision-loss result. It is not converted into an independent-living maintenance rate, blindness/activity-improvement percentage or minimum important functional difference. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Original loss denominators/CI, prespecified hierarchy and individual linkage to daily-life status remain unverified. Existing content review remains incomplete.	Distinguishing the original vision-loss threshold from direct daily-function events	Proposal: Separate vision-loss and direct-function materials. No new research, calculation or trial was performed.
16	Unverified	Full text not readStored summary read	N16 · Efficacy comparison and presentation of stored materialDo month-24 observations during repeated treatment differ from daily-function persistence after treatment?Required	Original treatment repeated every 4 months and month-24 BCVA reporting are preserved. These are not extended to daily-life benefit after treatment, lifelong independence or effects under other schedules/devices. S01	Required information is unverified in the preserved summary. Functional/independence follow-up after exposure ends and long-term clinical events remain unverified. Existing content review remains incomplete.	During/after exposure, beyond observation and long-term daily-life clinical outcomes	Proposal: Document functional gaps by period and exposure phase. No new research, calculation or trial was performed.
17	Partly verified	Full text not readStored summary read	N17 · Efficacy comparison and presentation of stored materialAre one report, eyes/time points and two tables new independent replications?Required	This table and the BCVA table share the same preserved summary, LIGHTSITE III month-24 report and patients/eyes. 1 bibliography entry, repeated time points/eyes and two endpoints 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 clinical trial, participant and independent-replication totals are not certified and remain unrecorded. Existing content review remains incomplete.	The same LIGHTSITE III, 100 people and 148 eyes shared by two questions	Proposal: Record links among shared populations and repeated materials. No new research, calculation or trial was performed.
18	Partly verified	Full text not readStored summary read	N18 · Efficacy comparison and presentation of stored materialWhat is the scope of manufacturer support, NEI funding and five author relationships?Required	Original LumiThera+NEI1R43EY025508-03 and 5 employee-or-consultant authors are preserved. Individual relationships/roles are not newly assigned, and public support alone does not establish independence. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Contracts/individual-author COI, analysis/writing roles, free devices and publication authority remain unverified. Existing content review remains incomplete.	Original company/public support, employees/consultants, roles and COI	Proposal: Provide separate materials on support types and actual roles. No new research, calculation or trial was performed.
19	Partly verified	Full text not readStored summary read	N19 · Efficacy comparison and presentation of stored materialWere daily-function registration and plans actually read?Required	Original NCT04065490 is preserved and distinguished from prespecified month-13/21 BCVA wording. The registration number is not used as prespecified confirmation of daily function or reading of protocol/SAP. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Functional prespecification/time points, multiplicity, amendment history and SAP remain unread. Existing content review remains incomplete.	NCT04065490 identifier, functional hierarchy/multiplicity and versions	Proposal: Link registration versions to functional-endpoint plans. No new research, calculation or trial was performed.
20	Partly verified	Full text not readStored summary read	N20 · Harm-information gaps supplementing the efficacy tableAre ocular AE/serious AE results measures of daily-life independence safety?Supplementary	Original ocular AE 25.8%/25.5% and serious ocular AE 7.5%/5.5% are separate safety results. They are not converted into daily-function/independence improvement or certification of safe device use. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Event counts/denominators, eyes/people, collection/periods/omissions and CI remain unverified. Existing content review remains incomplete.	25.8/25.5%, 7.5/5.5% and denominators/definitions/periods	Proposal: Separate safety events from direct daily-life outcomes. No new research, calculation or trial was performed.
21	Partly verified	Full text not readStored summary read	N21 · Harm-information gaps supplementing the efficacy tableDoes no report of treatment-related serious events/phototoxicity mean no harms?Supplementary	The original wording that treatment-related serious adverse events and phototoxicity signals were not reported is preserved. It is not extended to zero risk, overall safety, long-term independence or other-device safety. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Relatedness adjudication, long-term/vulnerable populations, omissions and precision remain unverified. Existing content review remains incomplete.	Unreported signals, causality/collection/follow-up, long term and vulnerable populations	Proposal: Document reported signals and unverified harms. No new research, calculation or trial was performed.
22	Partly verified	Full text not readStored summary read	N22 · Efficacy comparison and presentation of stored materialCan results be generalized to other devices, diseases and daily-life support?Required	The selected daily-function question concerns gaps in the original Valeda dry-AMD trial. No instructions are written for other light devices/diseases, driving permission, independent-living rehabilitation, administration or treatment replacement. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Direct daily-life/clinical results and separate independent materials under other conditions remain unverified. Existing content review remains incomplete.	Valeda in dry AMD, the relevant comparator/exposure and materials outside that scope	Proposal: Document condition/device-specific functional gaps. No new research, calculation or trial was performed.
23	Partly verified	Full text not readStored summary read	N23 · Efficacy comparison and presentation of stored materialAt what level were the summary, external materials and hyperlinks actually 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; the historical work did not test external-link operation, papers or tables. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. External clinical-material access, abstract/full-text/plan reading and paper comparison were not performed in the recorded work. Existing content review remains incomplete.	Preserved summary, original paper URL/registration and unread/not-accessed status	Proposal: Record acquisition/reading status and versions by material. No new research, calculation or trial was performed.
24	Partly verified	Full text not readStored summary read	N24 · Efficacy comparison and presentation of stored materialHow are original subclaim ?, parent C50, Korean/English texts and corrections/empty values preserved?Required	The complete preserved summary's parent C50/Caution, Korean/English texts, original axes, unrecorded/false values, empty corrections/deliberation and 2026-08-26 are preserved. Subclaim ? grade/note and absent score/status/axes are not filled with parent C50 or D. S01	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. At original authoring, grade changes, verdict-manuscript translation, clinical-original review, corrections and external updating were not performed. Existing content review remains incomplete.	Separate selected values, absent score, 2026-08-26 and unrecorded/false precision indicators	Proposal: Link original versions/dates to the subclaim functional question. No new research, calculation or trial was performed.
25	Partly verified	Full text not readStored summary read	N25 · Efficacy comparison and presentation of stored materialHow are condition/table production and user review separate events?Required	Condition preservation, freezing, separate application, case production and content review are separate records. Existing content review remains incomplete; production-entry counts do not establish completed clinical review or unique clinical trial/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. At original authoring, self/peer review, tests and screen/link checks were not performed. Existing content review remains incomplete.	Condition preservation, freezing, separate application, case production and incomplete review	Proposal: Record condition/production versions and user-change history. No new research, calculation or trial was performed.

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25 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: The same LIGHTSITE III patients/eyes with dry AMD; analyzed people/denominators for daily function remain unverified
Ingredient, formulation and route: Original historical Valeda/sham study conditions; not individual daily-life/device-use instructions
Dose: Not recorded
Comparator: A direct function/independence question separate from original BCVA materials in the sham comparison
Measured outcome: Daily visual function and independent living distinguished from exploratory quality of life and the BCVA surrogate
Duration: Actual periods for direct function/independence remain unverified; BCVA time points are not transferred
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 ? grade/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: The original Korean counterview states that vision-related quality of life was also explored, but BCVA was primary. The subclaim note states that daily visual function/independence was not the primary endpoint and remains unestablished. Statistical month-21/24 BCVA differences and >5-letter loss in 7%/18% are not direct daily-life/independence values. Functional measures, values/CI/P, prespecified hierarchy and denominators/periods remain unverified; no new effect or verdict is created.
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 · What are the existing values for the daily visual-function and independence question?

Required materials and conditions: Distinguishing subclaim ? grade/note and absent score/status/axes from parent C50
Conditions for verification: Original materials and analysis scope covering Distinguishing subclaim ? grade/note and absent score/status/axes from parent C50 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 subclaim ? grade/note and absent score/status/axes from parent C50 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

N02 · What direct outcomes are needed for daily visual function and independent living?

Required materials and conditions: Clear patient-level measurement of reading, driving, daily function and independence
Conditions for verification: Original materials and analysis scope covering Clear patient-level measurement of reading, driving, daily function and independence 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 Clear patient-level measurement of reading, driving, daily function and independence 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 Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension

N03 · Do statistically different BCVA results establish daily function?

Required materials and conditions: Distinguishing surrogates, direct function and between-arm estimands
Conditions for verification: Original materials and analysis scope covering Distinguishing surrogates, direct function and between-arm estimands 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 surrogates, direct function and between-arm estimands to link the materials needed for the selected question with those currently available.
Referenced methods: M03 §3.2.4; own boundary for extrapolation; M15 §15.3.1–15.3.3; own application

N04 · At what reporting level was vision-related quality of life explored?

Required materials and conditions: Distinguishing the original Korean exploratory wording, primary time points and functional endpoints/hierarchy
Conditions for verification: Original materials and analysis scope covering Distinguishing the original Korean exploratory wording, primary time points and functional endpoints/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 Distinguishing the original Korean exploratory wording, primary time points and functional endpoints/hierarchy 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, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design

N05 · Are prespecified month-13/21 BCVA and month-24 reporting daily-function time points?

Required materials and conditions: Time-specific endpoints and actual functional-outcome periods/hierarchy
Conditions for verification: Original materials and analysis scope covering Time-specific endpoints and actual functional-outcome periods/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 Time-specific endpoints and actual functional-outcome periods/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 outcome adaptations are our own design; M08 Table 8.2.a, M04 §4.6.3; our own application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design

N06 · Were actual daily-life improvement values for reading and driving provided?

Required materials and conditions: Distinguishing illustrative activities from measured activity results/denominators
Conditions for verification: Original materials and analysis scope covering Distinguishing illustrative activities from measured activity results/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 Distinguishing illustrative activities from measured activity results/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 outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension

N07 · Are independent living and blindness prevention direct results in these materials?

Required materials and conditions: Distinguishing independence/clinical events from the scope of BCVA
Conditions for verification: Original materials and analysis scope covering Distinguishing independence/clinical events from the scope of BCVA 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 independence/clinical events from the scope of BCVA to link the materials needed for the selected question with those currently available.
Referenced methods: M03 §3.2.4; own boundary for extrapolation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design

N08 · Which of 100 participants and 148 eyes is the daily-function denominator?

Required materials and conditions: Distinguishing person-level function, eye-specific BCVA, bilateral eyes and analysis populations
Conditions for verification: Original materials and analysis scope covering Distinguishing person-level function, eye-specific BCVA, bilateral eyes and analysis populations 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 person-level function, eye-specific BCVA, bilateral eyes and analysis populations 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

N09 · How do 20 discontinuations relate to losses in daily-function data?

Required materials and conditions: Discontinued people, eyes/function responses, arms/time points and missingness
Conditions for verification: Original materials and analysis scope covering Discontinued people, eyes/function responses, arms/time points 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 people, eyes/function responses, arms/time points 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, M19 §19.1.2–19.2.4; design-specific adaptation is our own design; M08 §8.2.2, M15 §15.3.1; own application; M19 §19.1.2–19.2.4, M04 §4.6.3; own application

N10 · What were the actual population and baseline daily-function status?

Required materials and conditions: Dry AMD, 10 US centers, baseline vision/function and eligibility
Conditions for verification: Original materials and analysis scope covering Dry AMD, 10 US centers, baseline vision/function and eligibility 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 Dry AMD, 10 US centers, baseline vision/function and eligibility 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

N11 · What are the study-device, repeated-exposure and daily-function comparison terms?

Required materials and conditions: Original Valeda, historical repeated treatment, active sham and actual exposure
Conditions for verification: Original materials and analysis scope covering Original Valeda, historical repeated treatment, active sham and actual exposure 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 Valeda, historical repeated treatment, active sham and actual exposure 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

N12 · Were randomization and masking verified for functional-outcome measurement?

Required materials and conditions: 2:1 allocation, double masking, patient responses, assessors and conditions
Conditions for verification: Original materials and analysis scope covering 2:1 allocation, double masking, patient responses, assessors and conditions 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 2:1 allocation, double masking, patient responses, assessors and conditions to link the materials needed for the selected question with those currently available.
Referenced methods: M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application

N13 · Which estimands and models were used for daily-function analysis?

Required materials and conditions: Patient scales/events, eye/repeated-observation structure, within/between arms and CI
Conditions for verification: Original materials and analysis scope covering Patient scales/events, eye/repeated-observation structure, within/between arms and CI 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 Patient scales/events, eye/repeated-observation structure, within/between arms and CI 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

N14 · Does an unverified minimum important BCVA difference provide a functional threshold?

Required materials and conditions: Distinguishing surrogate importance, direct-function importance and statistical differences
Conditions for verification: Original materials and analysis scope covering Distinguishing surrogate importance, direct-function importance and statistical differences 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 surrogate importance, direct-function importance and statistical differences 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

N15 · Does month-24 >5-letter loss in 7%/18% mean improved independent living?

Required materials and conditions: Distinguishing the original vision-loss threshold from direct daily-function events
Conditions for verification: Original materials and analysis scope covering Distinguishing the original vision-loss threshold from direct daily-function events 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 vision-loss threshold from direct daily-function events 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 Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension

N16 · Do month-24 observations during repeated treatment differ from daily-function persistence after treatment?

Required materials and conditions: During/after exposure, beyond observation and long-term daily-life clinical outcomes
Conditions for verification: Original materials and analysis scope covering During/after exposure, beyond observation and long-term daily-life clinical 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 During/after exposure, beyond observation and long-term daily-life clinical outcomes 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

N17 · Are one report, eyes/time points and two tables new independent replications?

Required materials and conditions: The same LIGHTSITE III, 100 people and 148 eyes shared by two questions
Conditions for verification: Original materials and analysis scope covering The same LIGHTSITE III, 100 people and 148 eyes shared by 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 The same LIGHTSITE III, 100 people and 148 eyes shared by 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

N18 · What is the scope of manufacturer support, NEI funding and five author relationships?

Required materials and conditions: Original company/public support, employees/consultants, roles and COI
Conditions for verification: Original materials and analysis scope covering Original company/public support, employees/consultants, 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 Original company/public support, employees/consultants, 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.

N19 · Were daily-function registration and plans actually read?

Required materials and conditions: NCT04065490 identifier, functional hierarchy/multiplicity and versions
Conditions for verification: Original materials and analysis scope covering NCT04065490 identifier, functional hierarchy/multiplicity and versions 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, functional hierarchy/multiplicity and versions 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

N20 · Are ocular AE/serious AE results measures of daily-life independence safety?

Required materials and conditions: 25.8/25.5%, 7.5/5.5% and denominators/definitions/periods
Conditions for verification: Original materials and analysis scope covering 25.8/25.5%, 7.5/5.5% and denominators/definitions/periods 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 25.8/25.5%, 7.5/5.5% and denominators/definitions/periods 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

N21 · Does no report of treatment-related serious events/phototoxicity mean no harms?

Required materials and conditions: Unreported signals, causality/collection/follow-up, long term and vulnerable populations
Conditions for verification: Original materials and analysis scope covering Unreported signals, causality/collection/follow-up, long term and vulnerable populations 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 Unreported signals, causality/collection/follow-up, long term and vulnerable populations to link the materials needed for the selected question with those currently available.
Referenced methods: M19 §19.1.2–19.2.4; own application; M19 §19.1.2–19.2.4, M04 §4.6.3; own application; M19 §19.1.2–19.2.4; own application; Chamgap's own interpretation boundary. M19 principles inform this; no official causality tool was run

N22 · Can results be generalized to other devices, diseases and daily-life support?

Required materials and conditions: Valeda in dry AMD, the relevant comparator/exposure and materials outside that scope
Conditions for verification: Original materials and analysis scope covering Valeda in dry AMD, the relevant comparator/exposure and 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 relevant comparator/exposure and 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

N23 · At what level were the summary, external materials and hyperlinks actually read?

Required materials and conditions: Preserved summary, original paper URL/registration and unread/not-accessed status
Conditions for verification: Original materials and analysis scope covering Preserved summary, original paper URL/registration and unread/not-accessed status 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 Preserved summary, original paper URL/registration and unread/not-accessed status 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

N24 · How are original subclaim ?, parent C50, Korean/English texts and corrections/empty values preserved?

Required materials and conditions: Separate selected values, absent score, 2026-08-26 and unrecorded/false precision indicators
Conditions for verification: Original materials and analysis scope covering Separate selected values, absent score, 2026-08-26 and unrecorded/false precision indicators 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 selected values, absent score, 2026-08-26 and unrecorded/false precision indicators 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

N25 · How are condition/table production and user review separate events?

Required materials and conditions: Condition preservation, freezing, separate application, case production and incomplete review
Conditions for verification: Original materials and analysis scope covering Condition preservation, freezing, separate application, case production and incomplete 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 Condition preservation, freezing, separate application, case production and incomplete 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

The public page and data were prepared from the existing 25 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 · What are the existing values for the daily visual-function and independence question?

Current findings: The selected existing question is improved daily visual function and independence, with original grade ? and a note that it was not the primary endpoint and remains unestablished. It is separate from the parent's BCVA C50 and original axes; subclaim score, status and axes are absent.
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. No new grade, score or effect is assigned to daily function. Existing content review remains incomplete.
Reason for missing information: No new grade, score or effect is assigned to daily function.
Required materials and conditions: Distinguishing subclaim ? grade/note and absent score/status/axes from parent C50
Materials to obtain first: Relevant direct materials or user comments
Further research: Proposal: Record separate sources for the daily-function question and parent surrogate verdict. 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 subclaim ? grade/note and absent score/status/axes from parent C50 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 subclaim ? grade/note and absent score/status/axes from parent C50 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

Related sources S01

N02 · What direct outcomes are needed for daily visual function and independent living?

Current findings: The original counterview states that improvement of a few chart letters is not the same as improved reading, driving or independent living. Eye-specific BCVA results are not transferred to patients' daily-life outcomes.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Required information is unverified in the preserved summary. Definitions, measures, periods, events/denominators and between-arm values for each function/independence outcome remain unverified. Existing content review remains incomplete.
Reason for missing information: Definitions, measures, periods, events/denominators and between-arm values for each function/independence outcome remain unverified.
Required materials and conditions: Clear patient-level measurement of reading, driving, daily function and independence
Materials to obtain first: Direct function/independence outcomes, measures and prespecified plans
Further research: Proposal: Provide separate endpoint materials for direct daily function and independence. 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 Clear patient-level measurement of reading, driving, daily function and independence 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 Clear patient-level measurement of reading, driving, daily function and independence 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 Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension

Related sources S01

N03 · Do statistically different BCVA results establish daily function?

Current findings: Month 21 +6.2 versus +2.4 letters, P=.0036, and month 24 +5.6 versus +1.3, P=.0024, are original BCVA results. They are not converted into daily-function/independence values, risks or differences; original subclaim ? 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. Patient-level surrogate linkage, between-arm function values/CI and clinical importance remain unverified. Existing content review remains incomplete.
Reason for missing information: Patient-level surrogate linkage, between-arm function values/CI and clinical importance remain unverified.
Required materials and conditions: Distinguishing surrogates, direct function and between-arm estimands
Materials to obtain first: Direct function results and BCVA/function linkage materials
Further research: Proposal: Separate surrogate and direct-outcome 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 surrogates, direct function and between-arm estimands 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 surrogates, direct function and between-arm estimands 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; M15 §15.3.1–15.3.3; own application

Related sources S01

N04 · At what reporting level was vision-related quality of life explored?

Current findings: The original Korean counterview states that vision-related quality of life was also explored while BCVA was primary. Exploratory wording is not promoted to prespecified functional confirmation or quality-of-life benefit.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Required information is unverified in the preserved summary. Measures/items, time points, denominators, values/CI/P, multiplicity and prespecification remain unverified. Existing content review remains incomplete.
Reason for missing information: Measures/items, time points, denominators, values/CI/P, multiplicity and prespecification remain unverified.
Required materials and conditions: Distinguishing the original Korean exploratory wording, primary time points and functional endpoints/hierarchy
Materials to obtain first: Original quality-of-life tables, measures/items and prespecified plans
Further research: Proposal: Link exploratory quality of life to prespecified 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 Distinguishing the original Korean exploratory wording, primary time points and functional endpoints/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 Distinguishing the original Korean exploratory wording, primary time points and functional endpoints/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: M08 Table 8.2.a, M04 §4.6.3; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design

Related sources S01

N05 · Are prespecified month-13/21 BCVA and month-24 reporting daily-function time points?

Current findings: The prespecified primary time points at months 13 and 21 concern BCVA change, and month-24 reporting also contains original BCVA values. They are not automatically transferred to daily-function/independence measurements over the same period or to primary functional endpoints.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Required information is unverified in the preserved summary. Functional-outcome time points/follow-up, prespecified analysis hierarchy and long-term periods remain unverified. Existing content review remains incomplete.
Reason for missing information: Functional-outcome time points/follow-up, prespecified analysis hierarchy and long-term periods remain unverified.
Required materials and conditions: Time-specific endpoints and actual functional-outcome periods/hierarchy
Materials to obtain first: Functional time points/follow-up and original registration/protocol/SAP
Further research: Proposal: Document periods and hierarchy for each endpoint. 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 Time-specific endpoints and actual functional-outcome periods/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 Time-specific endpoints and actual functional-outcome periods/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 outcome adaptations are our own design; M08 Table 8.2.a, M04 §4.6.3; our own application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design

Related sources S01

N06 · Were actual daily-life improvement values for reading and driving provided?

Current findings: The manuscript mentions reading and driving as examples of daily-life outcomes different from BCVA. They are not written as verified activity measurements or improvement percentages.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Required information is unverified in the preserved summary. Activity conditions, functional measurement, denominators, follow-up and between-arm results/CI remain unverified. Existing content review remains incomplete.
Reason for missing information: Activity conditions, functional measurement, denominators, follow-up and between-arm results/CI remain unverified.
Required materials and conditions: Distinguishing illustrative activities from measured activity results/denominators
Materials to obtain first: Activity-specific direct outcomes and original measures/plans
Further research: Proposal: Separate activity examples from measured direct results. 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 illustrative activities from measured activity results/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 Distinguishing illustrative activities from measured activity results/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 outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension

Related sources S01

N07 · Are independent living and blindness prevention direct results in these materials?

Current findings: The original advertising interpretation states that chart scores should not be extended to blindness prevention or improved independent living. No new statement is made that independent-living status or blindness events were collected.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Required information is unverified in the preserved summary. Direct event definitions, person/time denominators, follow-up/censoring and original between-arm intervals remain unverified. Existing content review remains incomplete.
Reason for missing information: Direct event definitions, person/time denominators, follow-up/censoring and original between-arm intervals remain unverified.
Required materials and conditions: Distinguishing independence/clinical events from the scope of BCVA
Materials to obtain first: When direct independent-living/clinical-event outcomes are supplied
Further research: Proposal: Link direct clinical-event and surrogate 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 independence/clinical events from the scope of BCVA 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 independence/clinical events from the scope of BCVA 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; 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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N08 · Which of 100 participants and 148 eyes is the daily-function denominator?

Current findings: The original randomized denominators of 100 people and 148 eyes refer to people/eyes in the BCVA trial. The 148 eyes are not repurposed as independent-living participants, and each eye/time point is not counted as a new person.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Required information is unverified in the preserved summary. Daily-function questionnaire respondents/analyzed people, bilateral-eye/time-point correspondence and arm-specific denominators remain unverified. Existing content review remains incomplete.
Reason for missing information: Daily-function questionnaire respondents/analyzed people, bilateral-eye/time-point correspondence and arm-specific denominators remain unverified.
Required materials and conditions: Distinguishing person-level function, eye-specific BCVA, bilateral eyes and analysis populations
Materials to obtain first: Functional responses/analysis populations and eye/person linkage tables
Further research: Proposal: Document eye and patient-function 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 person-level function, eye-specific BCVA, bilateral eyes and analysis populations 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 person-level function, eye-specific BCVA, bilateral eyes and analysis populations 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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N09 · How do 20 discontinuations relate to losses in daily-function data?

Current findings: 20 discontinuations among 100 participants and original 20% attrition are trial context. These are not assumed to mean 20 missing daily-function responses or a remaining response count; no new completion proportion is 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. Missing functional responses, discontinuation arms/time points/reasons and imputation/follow-up remain unverified. Existing content review remains incomplete.
Reason for missing information: Missing functional responses, discontinuation arms/time points/reasons and imputation/follow-up remain unverified.
Required materials and conditions: Discontinued people, eyes/function responses, arms/time points and missingness
Materials to obtain first: Functional response/discontinuation flow and missingness/analysis plans
Further research: Proposal: Link trial discontinuation to losses in functional 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 people, eyes/function responses, arms/time points 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 people, eyes/function responses, arms/time points 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, M19 §19.1.2–19.2.4; design-specific adaptation is our own design; M08 §8.2.2, M15 §15.3.1; own application; M19 §19.1.2–19.2.4, M04 §4.6.3; own application

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N10 · What were the actual population and baseline daily-function status?

Current findings: The original population was 100 people with dry AMD at 10 US centers. Baseline reading, driving, independence, disease stage and acuity conditions are not arbitrarily 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. Baseline functional limitations, exact stage/age, inclusion/exclusion and representativeness for other populations remain unverified. Existing content review remains incomplete.
Reason for missing information: Baseline functional limitations, exact stage/age, inclusion/exclusion and representativeness for other populations remain unverified.
Required materials and conditions: Dry AMD, 10 US centers, baseline vision/function and eligibility
Materials to obtain first: Baseline function/disease tables, eligibility/exclusions and recruitment materials
Further research: Proposal: Link eligibility conditions to patient function. 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 Dry AMD, 10 US centers, baseline vision/function and eligibility 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 Dry AMD, 10 US centers, baseline vision/function and eligibility 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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N11 · What are the study-device, repeated-exposure and daily-function comparison terms?

Current findings: Original Valeda multiwavelength, repeated study exposure and active low-fluence sham are preserved. These conditions are not converted into administration instructions for daily-life rehabilitation or independence treatment.
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 exposure/adherence during function measurement, comparator conditions and concomitant treatment/aids/rehabilitation remain unverified. Existing content review remains incomplete.
Reason for missing information: Actual exposure/adherence during function measurement, comparator conditions and concomitant treatment/aids/rehabilitation remain unverified.
Required materials and conditions: Original Valeda, historical repeated treatment, active sham and actual exposure
Materials to obtain first: Actual exposure, shared/arm-specific concomitant support and plans
Further research: Proposal: Document device comparison and concomitant exposures. 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 Valeda, historical repeated treatment, active sham and actual exposure 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 Valeda, historical repeated treatment, active sham and actual exposure 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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N12 · Were randomization and masking verified for functional-outcome measurement?

Current findings: The original trial was a 2:1 randomized, double-masked sham comparison. This is not inherited as verified functional-scale assessors/response methods, allocation awareness or maintenance of masking.
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. Allocation unit/concealment, functional-assessment masking/awareness and assessment environment remain unverified. Existing content review remains incomplete.
Reason for missing information: Allocation unit/concealment, functional-assessment masking/awareness and assessment environment remain unverified.
Required materials and conditions: 2:1 allocation, double masking, patient responses, assessors and conditions
Materials to obtain first: Allocation/masking and functional-assessment instructions/data
Further research: Proposal: Link design to functional measurement. 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 2:1 allocation, double masking, patient responses, assessors and conditions 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 2:1 allocation, double masking, patient responses, assessors and conditions 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; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application

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N13 · Which estimands and models were used for daily-function analysis?

Current findings: The original approximate 3.8-letter between-arm LS difference concerns month-21 BCVA. It is not repurposed as a quality-of-life/independence scale score, probability or daily-improvement CI.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Required information is unverified in the preserved summary. Original functional analysis/adjustment, models/repetition, prespecified contrasts, CI/P and denominators remain unverified. Existing content review remains incomplete.
Reason for missing information: Original functional analysis/adjustment, models/repetition, prespecified contrasts, CI/P and denominators remain unverified.
Required materials and conditions: Patient scales/events, eye/repeated-observation structure, within/between arms and CI
Materials to obtain first: Original function tables, measures/models and SAP
Further research: Proposal: Link endpoint-specific estimands and models. 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 Patient scales/events, eye/repeated-observation structure, within/between arms and CI 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 Patient scales/events, eye/repeated-observation structure, within/between arms and CI 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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N14 · Does an unverified minimum important BCVA difference provide a functional threshold?

Current findings: An original prespecified minimum important BCVA letter difference was not identified. Statistical BCVA differences, a few letters or an unverified prespecified threshold are not used to create daily-function important differences or responder criteria.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Required information is unverified in the preserved summary. Prespecified minimum important differences, intervals, response criteria and validation for functional measures remain unverified. Existing content review remains incomplete.
Reason for missing information: Prespecified minimum important differences, intervals, response criteria and validation for functional measures remain unverified.
Required materials and conditions: Distinguishing surrogate importance, direct-function importance and statistical differences
Materials to obtain first: Functional-importance definitions, prespecified plans and original intervals
Further research: Proposal: Provide materials for surrogate and functional importance separately. 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 surrogate importance, direct-function importance and statistical differences 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 surrogate importance, direct-function importance and statistical differences 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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N15 · Does month-24 >5-letter loss in 7%/18% mean improved independent living?

Current findings: Original month-24 BCVA loss of more than 5 letters in 7%/18% is a vision-loss result. It is not converted into an independent-living maintenance rate, blindness/activity-improvement percentage or minimum important functional difference.
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 loss denominators/CI, prespecified hierarchy and individual linkage to daily-life status remain unverified. Existing content review remains incomplete.
Reason for missing information: Original loss denominators/CI, prespecified hierarchy and individual linkage to daily-life status remain unverified.
Required materials and conditions: Distinguishing the original vision-loss threshold from direct daily-function events
Materials to obtain first: Original loss tables/denominators, functional results and prespecified plans
Further research: Proposal: Separate vision-loss and direct-function 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 the original vision-loss threshold from direct daily-function events 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 vision-loss threshold from direct daily-function events 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 Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension

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N16 · Do month-24 observations during repeated treatment differ from daily-function persistence after treatment?

Current findings: Original treatment repeated every 4 months and month-24 BCVA reporting are preserved. These are not extended to daily-life benefit after treatment, lifelong independence or effects under other schedules/devices.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Required information is unverified in the preserved summary. Functional/independence follow-up after exposure ends and long-term clinical events remain unverified. Existing content review remains incomplete.
Reason for missing information: Functional/independence follow-up after exposure ends and long-term clinical events remain unverified.
Required materials and conditions: During/after exposure, beyond observation and long-term daily-life clinical outcomes
Materials to obtain first: Exposure/follow-up endpoints and long-term functional materials
Further research: Proposal: Document functional gaps by period and exposure phase. 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 During/after exposure, beyond observation and long-term daily-life clinical 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 During/after exposure, beyond observation and long-term daily-life clinical 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 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design

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N17 · Are one report, eyes/time points and two tables new independent replications?

Current findings: This table and the BCVA table share the same preserved summary, LIGHTSITE III month-24 report and patients/eyes. 1 bibliography entry, repeated time points/eyes and two endpoints 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 clinical trial, participant and independent-replication totals are not certified and remain unrecorded. Existing content review remains incomplete.
Reason for missing information: Unique clinical trial, participant and independent-replication totals are not certified and remain unrecorded.
Required materials and conditions: The same LIGHTSITE III, 100 people and 148 eyes shared by two questions
Materials to obtain first: When report/trial/patient/eye/follow-up relationships are supplied
Further research: Proposal: Record links among shared populations and repeated 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 The same LIGHTSITE III, 100 people and 148 eyes shared by 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 The same LIGHTSITE III, 100 people and 148 eyes shared by 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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N18 · What is the scope of manufacturer support, NEI funding and five author relationships?

Current findings: Original LumiThera+NEI1R43EY025508-03 and 5 employee-or-consultant authors are preserved. Individual relationships/roles are not newly assigned, and public support alone does not establish independence.
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. Contracts/individual-author COI, analysis/writing roles, free devices and publication authority remain unverified. Existing content review remains incomplete.
Reason for missing information: Contracts/individual-author COI, analysis/writing roles, free devices and publication authority remain unverified.
Required materials and conditions: Original company/public support, employees/consultants, roles and COI
Materials to obtain first: Original support/contribution/COI and product/data-rights contracts
Further research: Proposal: Provide separate materials on support types and actual roles. 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 company/public support, employees/consultants, 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 Original company/public support, employees/consultants, 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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N19 · Were daily-function registration and plans actually read?

Current findings: Original NCT04065490 is preserved and distinguished from prespecified month-13/21 BCVA wording. The registration number is not used as prespecified confirmation of daily function or reading of protocol/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. Functional prespecification/time points, multiplicity, amendment history and SAP remain unread. Existing content review remains incomplete.
Reason for missing information: Functional prespecification/time points, multiplicity, amendment history and SAP remain unread.
Required materials and conditions: NCT04065490 identifier, functional hierarchy/multiplicity and versions
Materials to obtain first: Registration/protocol/SAP copies or user materials
Further research: Proposal: Link registration versions to functional-endpoint 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, functional hierarchy/multiplicity and versions 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, functional hierarchy/multiplicity and versions 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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N20 · Are ocular AE/serious AE results measures of daily-life independence safety?

Current findings: Original ocular AE 25.8%/25.5% and serious ocular AE 7.5%/5.5% are separate safety results. They are not converted into daily-function/independence improvement or certification of safe device use.
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. Event counts/denominators, eyes/people, collection/periods/omissions and CI remain unverified. Existing content review remains incomplete.
Reason for missing information: Event counts/denominators, eyes/people, collection/periods/omissions and CI remain unverified.
Required materials and conditions: 25.8/25.5%, 7.5/5.5% and denominators/definitions/periods
Materials to obtain first: Safety tables, collection/exposure/follow-up and denominators
Further research: Proposal: Separate safety events from direct daily-life 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 25.8/25.5%, 7.5/5.5% and denominators/definitions/periods 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 25.8/25.5%, 7.5/5.5% and denominators/definitions/periods 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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N21 · Does no report of treatment-related serious events/phototoxicity mean no harms?

Current findings: The original wording that treatment-related serious adverse events and phototoxicity signals were not reported is preserved. It is not extended to zero risk, overall safety, long-term independence or other-device safety.
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. Relatedness adjudication, long-term/vulnerable populations, omissions and precision remain unverified. Existing content review remains incomplete.
Reason for missing information: Relatedness adjudication, long-term/vulnerable populations, omissions and precision remain unverified.
Required materials and conditions: Unreported signals, causality/collection/follow-up, long term and vulnerable populations
Materials to obtain first: Safety collection/adjudication and long-term materials
Further research: Proposal: Document reported signals and 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 Unreported signals, causality/collection/follow-up, long term and vulnerable populations 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 Unreported signals, causality/collection/follow-up, long term and vulnerable populations 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; own application; M19 §19.1.2–19.2.4, M04 §4.6.3; own application; M19 §19.1.2–19.2.4; own application; Chamgap's own interpretation boundary. M19 principles inform this; no official causality tool was run

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N22 · Can results be generalized to other devices, diseases and daily-life support?

Current findings: The selected daily-function question concerns gaps in the original Valeda dry-AMD trial. No instructions are written for other light devices/diseases, driving permission, independent-living rehabilitation, administration or treatment replacement.
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 daily-life/clinical results and separate independent materials under other conditions remain unverified. Existing content review remains incomplete.
Reason for missing information: Direct daily-life/clinical results and separate independent materials under other conditions remain unverified.
Required materials and conditions: Valeda in dry AMD, the relevant comparator/exposure and materials outside that scope
Materials to obtain first: When condition-specific direct materials are supplied
Further research: Proposal: Document condition/device-specific functional 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 relevant comparator/exposure and 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 relevant comparator/exposure and 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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N23 · At what level were the summary, external materials and hyperlinks actually 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; the historical work did not test external-link operation, papers or tables.
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, abstract/full-text/plan reading and paper comparison were not performed in the recorded work. Existing content review remains incomplete.
Reason for missing information: External clinical-material access, abstract/full-text/plan reading and paper comparison were not performed in the recorded work.
Required materials and conditions: Preserved summary, original paper URL/registration and unread/not-accessed status
Materials to obtain first: User-supplied 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 Preserved summary, original paper URL/registration and unread/not-accessed status 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 Preserved summary, original paper URL/registration and unread/not-accessed status 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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N24 · How are original subclaim ?, parent C50, Korean/English texts and corrections/empty values preserved?

Current findings: The complete preserved summary's parent C50/Caution, Korean/English texts, original axes, unrecorded/false values, empty corrections/deliberation and 2026-08-26 are preserved. Subclaim ? grade/note and absent score/status/axes are not filled with parent C50 or D.
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, grade changes, verdict-manuscript translation, clinical-original review, corrections and external updating were not performed. Existing content review remains incomplete.
Reason for missing information: At original authoring, grade changes, verdict-manuscript translation, clinical-original review, corrections and external updating were not performed.
Required materials and conditions: Separate selected values, absent score, 2026-08-26 and unrecorded/false precision indicators
Materials to obtain first: Original correction materials or user comments
Further research: Proposal: Link original versions/dates to the subclaim functional question. 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 selected values, absent score, 2026-08-26 and unrecorded/false precision indicators 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 selected values, absent score, 2026-08-26 and unrecorded/false precision indicators 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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N25 · How are condition/table production and user review separate events?

Current findings: Condition preservation, freezing, separate application, case production and content review are separate records. Existing content review remains incomplete; production-entry counts do not establish completed clinical review or unique clinical trial/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. At original authoring, self/peer review, tests and screen/link checks were not performed. Existing content review remains incomplete.
Reason for missing information: Existing content review remains incomplete. At original authoring, self/peer review, tests and screen/link checks were not performed.
Required materials and conditions: Condition preservation, freezing, separate application, case production and incomplete review
Materials to obtain first: User review feedback and additional preserved 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 Condition preservation, freezing, separate application, case production and incomplete 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 Condition preservation, freezing, separate application, case production and incomplete 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

Related sources S01