Table 2.

Data extraction form

Review author
Study 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
Participants	Total number, number in each group (sample size) Comparability Setting
Risk of bias	Assessed using risk of bias tool (see Handbook)
Outcomes (as defined in study) Please specify which	Primary outcome Mean distance (3, 4 or 6 m) BCVA in the amblyopic eye at 12 months after the cessation of the interventions in logMAR units on an age‐appropriate acuity test. Secondary outcomes main secondary outcome: mean distance (3, 4 or 6 m) BCVA in the amblyopic eye at any timepoint during or after cessation of treatment in logMAR units on an age‐appropriate acuity test proportion of change in BCVA defined as “(BCVA of amblyopic eye at start – BCVA of amblyopic eye at end of treatment)/(BCVA of amblyopic eye at start – BCVA of fellow eye at end of treatment)” (Stewart 2003) stereopsis 12 months after cessation of treatment in seconds of arc stereopsis at any timepoint during or after cessation of treatment in seconds of arc proportion of participants achieving normal stereoacuity score of 60 seconds of arc or better 12 months after cessation of treatment proportion of participants achieving normal stereoacuity score of 60 seconds of arc or better at any timepoint during or after cessation of treatment proportion of participants with improvement in stereoacuity of 2 log levels or more (with 2 levels being the test‐retest variability for stereoacuity tests) at 12 months after cessation of treatment (Adams 2009; Wallace 2011) proportion of participants with improvement in stereoacuity of 2 log levels or more at any timepoint during or after cessation of treatment mean change in stereoacuity in log seconds of arc defined as "stereoacuity at start ‐ stereoacuity at end of treatment" compliance or adherence to interventions as daily dose in hours/day, determined by occlusion dose monitors, electronic compliance measures of binocular treatments, or parental treatment diaries (ratio of received dose/prescribed daily dose) compliance or adherence to interventions as total dose, determined by occlusion dose monitors, electronic compliance measures of binocular treatments, or parental treatment diaries (ratio of received dose/prescribed total dose) impact of treatment on quality of life measured by a validated tool such as CAT‐QoL (Carlton 2013) or ATI (Felius 2010) proportion of participants experiencing adverse events such as diplopia (double vision) or loss of BCVA > 1 line in either eye proportion of participants experiencing regression of BCVA in the amblyopic eye to baseline level (Malik 1975) or recurrence defined as a 2 or more logMAR lines (0.2 logMAR) deterioration in amblyopic eye BCVA (Holmes 2004) 12 months after cessation of treatment where available, we will include analysis of cost‐effectiveness or cost‐utility of treatments
Interventions compared	Intervention 1 = Standard care (occlusion or pharmacological blurring) Intervention 2 = Binocular treatment
PRIMARY OUTCOME: Mean distance (3, 4 or 6 m) BCVA in the amblyopic eye at 12 months after the cessation of the interventions in logMAR units on an age‐appropriate acuity test.	Intervention 1			Intervention 2
Timepoint	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 intervention
Or: improvement of BCVA from baseline
SECONDARY OUTCOMES: mean distance (3, 4 or 6 m) BCVA in the amblyopic eye at any timepoint during or after cessation of treatment in logMAR units on an age‐appropriate acuity test	Intervention 1			Intervention 2
Timepoint	Total number of participants	Mean	Standard deviation*	Total number of participants	Mean	Standard deviation*
Baseline (note method used to measure BCVA)
Second timepoint (please specify)
Or: improvement of BCVA from baseline
SECONDARY OUTCOMES: proportion of change in BCVA defined by the equation “(BCVA of amblyopic eye at start ‐ BCVA of amblyopic eye at end of treatment)/(BCVA of amblyopic eye at start ‐ BCVA of fellow eye at end of treatment)”	Intervention 1			Intervention 2
Timepoint	Total number of participants	Mean	Standard deviation*	Total number of participants	Mean	Standard deviation*
End of treatment
SECONDARY OUTCOMES: Stereoacuity 12 months after cessation of intervention in seconds of arc	Intervention 1			Intervention 2
Timepoint	Total number of participants	Mean	Standard deviation*	Total number of participants	Mean	Standard deviation*
Baseline (note method used to measure stereoacuity)
12 months after cessation of intervention
SECONDARY OUTCOMES: Stereoacuity at any timepoint during or after cessation of intervention	Intervention 2			Intervention 2
Timepoint	Total number of participants	Mean	Standard deviation*	Total number of participants	Mean	Standard deviation*
Baseline
Second timepoint (please specify)
SECONDARY OUTCOMES: Proportion of participants achieving normal stereoacuity of 60 seconds of arc 12 months after cessation of treatment	Intervention 1	Intervention 2
Timepoint	Total number of participants	Mean	Standard deviation*	Total number of participants	Mean	Standard deviation*
12 months after cessation of treatment (note method used to measure stereoacuity)
SECONDARY OUTCOMES: Proportion of participants achieving normal stereoacuity of 60 seconds of arc at any timpoint during or after cessation of treatment	Intervention 1	Intervention 2
Timepoint	Total number of participants	Mean	Standard deviation*	Total number of participants	Mean	Standard deviation*
Second timepoint (please specify)
SECONDARY OUTCOMES: Proportion of participants with improvement in stereoacuity of 2 levels or more 12 months after cessation of treatment	Intervention 1	Intervention 2
Timepoint	Total number of participants	Mean	Standard deviation*	Total number of participants	Mean	Standard deviation*
12 months after cessation of treatment (note method used to measure stereoacuity)
SECONDARY OUTCOMES: Proportion of participants with improvement in stereoacuity of 2 levels or more at any timepoint during or after cessation of treatment	Intervention 1	Intervention 2
Timepoint	Total number of participants	Mean	Standard deviation*	Total number of participants	Mean	Standard deviation*
Second timepoint (please specify)
SECONDARY OUTCOMES: Mean change in stereoacuity in logarcsec defined as "stereoacuity at start ‐ stereoacuity at end of treatment"
Timepoint	Total number of participants	Mean	Standard deviation*	Total number of participants	Mean	Standard deviation*
End of treatment (note method used to measure stereoacuity and time from start of treatment)
SECONDARY OUTCOMES: Compliance or adherence to interventions as daily dose in hours/day (ratio of received/prescribed)	Intervention 1	Intervention 2
Timepoint	Total number of participants	Mean	Standard deviation*	Total number of participants	Mean	Standard deviation*
End of intervention (specify time from start of treatment)
SECONDARY OUTCOMES: Compliance or adherence to interventions as total dose (ratio of received/prescribed)	Intervention 1	Intervention 2
Timepoint	Total number of participants	Mean	Standard deviation*	Total number of participants	Mean	Standard deviation*
End of intervention (specify time from start of treatment)
SECONDARY OUTCOMES: Impact on QoL	Intervention 1			Intervention 2
Timepoint	Total number of participants	Mean	Standard deviation*	Total number of participants	Mean	Standard deviation*
Last measurement in trial (specify time from start of treatment)
SECONDARY OUTCOMES: Adverse events (diplopia, loss of BCVA in amblyopic eye > 0.10 logMAR, loss of BCVA in fellow eye > 0.10 logMAR, regression, recurrence, other)	Intervention 1			Intervention 2
Timepoint	Total number of participants	Number of affected participants		Total number of participants	Number of affected participants
Diplopia at 12 months after start of intervention
Loss of BCVA in amblyopic eye > 0.10 logMAR at 12 months after start of intervention
Loss of BCVA in fellow eye > 0.10 logMAR at 12 months after start of intervention
Regression of BCVA in amblyopic eye to baseline level at 12 months after start of intervention
Recurrence: deterioration of BCVA in amblyopic eye of 0.20 logMAR or more at 12 months after start of intervention
Other (specify)
SECONDARY OUTCOMES: Cost‐effectiveness or cost‐utility	Intervention 1			Intervention 2

ATI: Amblyopia Treatment Index BCVA: best‐corrected visual acuity CAT‐QoL: Child Amblyopia Treatment Questionnaire QoL: quality of life RCT: randomised controlled trial