1. Data extraction form.
Review author | ||||||
Trial registration ID | ||||||
Dates when study was conducted | If not available, comment "dates not available" | |||||
Funding source(s) | ||||||
Declarations of interest by researchers | ||||||
Methods | Study design (RCT) Interventions; mean dose prescribed and mean dose received |
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Participants | Total number, number in each group (sample size) Comparability Setting |
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Risk of bias | Assessed using risk of bias tool (see Handbook) | |||||
Outcomes (as defined in study) Please specify which |
Primary outcome Change in distance BCVA in the amblyopic eye following 16(±2) weeks of intervention, as measured in logMAR units on an age‐appropriate acuity test. Secondary outcomes
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Interventions compared | Intervention 1 = standard care (occlusion or pharmacological blurring) Intervention 2 = binocular treatment |
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PRIMARY OUTCOME Change in distance BCVA in the amblyopic eye following 16 (± 2) weeks of intervention, as measured in logMAR units on an age‐appropriate acuity test |
Intervention 1 | Intervention 2 | ||||
Time point | Total number of participants | Mean | Standard deviation* | Total number of participants | Mean | Standard deviation* |
Baseline (note method used to measure BCVA) | ||||||
BCVA at 16 (± 2) | ||||||
Or: improvement of BCVA from baseline | ||||||
SECONDARY OUTCOME Main secondary outcome: change in BCVA in the amblyopic eye from baseline to 8 (± 2) weeks, as measured in logMAR units on an age‐appropriate acuity test |
Intervention 1 | Intervention 2 | ||||
Time point | Total number of participants | Mean | Standard deviation* | Total number of participants | Mean | Standard deviation* |
Baseline (note method used to measure BCVA) | ||||||
BCVA at 8 (± 2) | ||||||
Or: improvement of BCVA from baseline | ||||||
SECONDARY OUTCOME Change in stereoacuity after 16 (± 2) weeks of intervention, measured in octaves |
Intervention 1 | Intervention 2 | ||||
Time point | Total number of participants | Mean | Standard deviation* | Total number of participants | Mean | Standard deviation* |
Baseline stereopsis | ||||||
Change in stereopsis after 16 (± 2) | ||||||
Change in stereoacuity after 8 (± 2) weeks of intervention, measured in octaves | ||||||
Time point | ||||||
Baseline stereopsis | ||||||
Change in stereopsis after 8 (± 2) | ||||||
SECONDARY OUTCOME Adherence to intervention determined by a ratio of usage/prescribed treatment dosage |
Intervention 1 | Intervention 2 | ||||
Time point | Total number of participants | Mean | Standard deviation* | Total number of participants | Mean | Standard deviation* |
End of intervention (specify time from start of treatment) | ||||||
SECONDARY OUTCOME Change in contrast sensitivity interocular difference from baseline to 16 (± 2) weeks measured using any validated test |
Intervention 1 | Intervention 2 | ||||
Time point | Total number of participants | Mean | Standard deviation* | Total number of participants | Mean | Standard deviation* |
End of intervention (specify test) | ||||||
SECONDARY OUTCOME Adverse events (Proportion of participants experiencing an adverse event of permanent diplopia (double vision) at any time point during intervention.) |
Intervention 1 | Intervention 2 | ||||
Time point | Total number of participants | Number of affected participants | Total number of participants | Number of affected participants | ||
Permanent diplopia | ||||||
Time point | ||||||
Other (specify) | ||||||
SECONDARY OUTCOME Change in distance BCVA in the amblyopic eye 12 months after cessation of treatment |
Intervention 1 | Intervention 2 | ||||
Time point | Total number of participants | Mean | Standard deviation* | Total number of participants | Mean | Standard deviation* |
Baseline (note method used to measure BCVA) | ||||||
12 months after cessation of treatment | ||||||
Or: improvement of BCVA from baseline to 12 months post‐treatment |
ATI: Amblyopia Treatment Index BCVA: best‐corrected visual acuity CAT‐QoL: Child Amblyopia Treatment Questionnaire QoL: quality of life RCT: randomised controlled trial