Skip to main content
. 2022 Feb 7;2022(2):CD011347. doi: 10.1002/14651858.CD011347.pub3

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
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
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
  • 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

  • Change in stereoacuity after 16 (± 2) and 8 (± 2) weeks of intervention, measured in octaves (Adams 2009)

  • Adherence to intervention determined by a ratio of usage/prescribed treatment dosage

  • Change in contrast sensitivity interocular difference from baseline to 16 (± 2) weeks, measured using any validated test

  • Proportion of participants experiencing an adverse event of permanent diplopia (double vision) at any time point during intervention

Interventions compared Intervention 1 = standard care (occlusion or pharmacological blurring)
Intervention 2 = binocular treatment
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