# Valeda × Improved daily visual function and independence in dry AMD — Evidence check sheet Verdict 2935 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-08-26 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-10 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - 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 ## Checklist items ### N01 · What are the existing values for the daily visual-function and independence question? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Unverified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Unverified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Unverified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Unverified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Unverified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N08 · Which of 100 participants and 148 eyes is the daily-function denominator? Verification status: Unverified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N09 · How do 20 discontinuations relate to losses in daily-function data? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N10 · What were the actual population and baseline daily-function status? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design - Related sources: S01 ### N11 · What are the study-device, repeated-exposure and daily-function comparison terms? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N12 · Were randomization and masking verified for functional-outcome measurement? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application - Related sources: S01 ### N13 · Which estimands and models were used for daily-function analysis? Verification status: Unverified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application - Related sources: S01 ### N14 · Does an unverified minimum important BCVA difference provide a functional threshold? Verification status: Unverified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M15 §15.3.1–15.3.3; Chamgap's own application; M03 §3.2.4; Chamgap's own limits on extension - Related sources: S01 ### N15 · Does month-24 >5-letter loss in 7%/18% mean improved independent living? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 ### N16 · Do month-24 observations during repeated treatment differ from daily-function persistence after treatment? Verification status: Unverified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design - Related sources: S01 ### N17 · Are one report, eyes/time points and two tables new independent replications? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N18 · What is the scope of manufacturer support, NEI funding and five author relationships? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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. - Related sources: S01 ### N19 · Were daily-function registration and plans actually read? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N20 · Are ocular AE/serious AE results measures of daily-life independence safety? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N21 · Does no report of treatment-related serious events/phototoxicity mean no harms? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N22 · Can results be generalized to other devices, diseases and daily-life support? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N23 · At what level were the summary, external materials and hyperlinks actually read? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 ### N24 · How are original subclaim ?, parent C50, Korean/English texts and corrections/empty values preserved? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design - Related sources: S01 ### N25 · How are condition/table production and user review separate events? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 ## Evidence and sources ### S01 LIGHTSITE III month-24 report [PubMed](https://pubmed.ncbi.nlm.nih.gov/41791029/) Materials actually read: Summary read; external material unread Findings recorded in the 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 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. | 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. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Preserved method HTML copies; no current method-content re-review or official tool execution - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Preserved method HTML copies; no current method-content re-review or official tool execution - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Preserved method HTML copies; no current method-content re-review or official tool execution - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · 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/materials 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.