An interventional study of eye-patching in Amblyopia, sponsored by Yarmouk University. Completed at 2 sites in Jordan. Open to participants aged 4 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Yarmouk University · Not applicable, Interventional, and Treatment
To determine whether the time of day at which daily occlusion therapy is administered-morning, with 2 hours of patching completed within 07:00-10:00, versus evening, with 2 hours completed within 17:00-20:00-affects visual-acuity improvement in the amblyopic eye in children with unilateral amblyopia.
Rationale:
While occlusion therapy remains the mainstay for treatment of childhood amblyopia, existing trials have focused on patching duration, not on the timing of occlusion. Diurnal or chronobiological factors - such as fluctuations in neuroplasticity, attention, compliance, or visual demand during the day - may influence the efficacy of patching. Understanding whether timing matters could help optimize occlusion therapy, improve outcomes, and reduce treatment burden.
Study Type: Prospective, randomized, parallel-group clinical trial.
Participants: Children aged 4-8 years with unilateral amblyopia; amblyopic-eye BCVA between 0.17-0.67 decimal (≈ 6/36-6/9); fellow-eye BCVA ≥ 0.80 decimal; refractive-dominant or strabismic/mixed amblyopia. Parental/guardian consent required.
Randomization \& Stratification: Participants randomized 1:1 to "Morning patching" vs "Evening patching" arms. Stratified by age (4-\<6 vs >=6-8), baseline visual acuity or amblyopia severity (moderate 6/36-\<6/12 vs mild 6/12-6/9), and amblyopia type (refractive-dominant vs strabismic/mixed) - to ensure balance across key prognostic variables.
Intervention: Participants received daily occlusion of the fellow eye for 2 hours within the assigned treatment window: 07:00-10:00 for the morning group and 17:00-20:00 for the evening group. Near-vision activities, such as reading, puzzles, or coloring, were encouraged during patching but were not formally quantified. Caregivers recorded the start time, end time, and duration of each patching session in a daily diary. Missed weekday patching could be made up on weekends according to the study protocol. Spectacle correction, when prescribed, was maintained throughout the study.
Follow-up / Assessments:
Baseline exam (BCVA both eyes, refraction, ocular alignment/strabismus assessment, anterior and posterior segment exam, stereoacuity, instructions on patching/adherence, randomization).
Midpoint follow-up at 3 months (BCVA, adherence, adverse events. Telehealth acceptable if in-person not possible.).
Final follow-up at 6 months (BCVA (primary endpoint), stereoacuity, ocular alignment/strabismus assessment, anterior segment exam, adherence data review, adverse events, patching compliance summary.).
Primary Outcome: Change in best-corrected visual acuity (BCVA) of the amblyopic eye from baseline to month 6.
Secondary Outcomes: Stereoacuity, caregiver-reported patching adherence within the assigned treatment window, and the proportion of participants achieving at least a 0.20 logMAR improvement from baseline to Month 6.
Statistical Approach: Analysis of covariance (ANCOVA) comparing mean change in BCVA between arms, adjusting for baseline VA and stratification factors. Subgroup analyses by amblyopia type, baseline severity, age group.
Sample Size and Power: Assuming a clinically meaningful between-group difference of 0.12 logMAR, a common standard deviation of 0.18 logMAR, a two-sided alpha of 0.05, and 80% power, 37 evaluable participants per group were required. The target enrollment was increased to 42 participants per group, for a total of 84, to allow for attrition or unavailable Month-6 outcomes.
Duration \& Timeline:
Each participant will be followed for 6 months of daily patching. The total study duration (from first enrollment to last follow-up) will depend on recruitment rate; estimated duration \~ 7-9 months including recruitment, follow-up, data cleaning, and analysis.
Significance \& Expected Impact:
If timing of occlusion influences visual outcome, this could refine occlusion therapy recommendations - potentially improving efficacy, adherence, and convenience for patients and families. The trial may identify a more effective or practical patching schedule, thereby contributing to evidence-based amblyopia management.
189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.
This study's enrollment of 84 is above the median of 60 across 137 interventional studies indexed under Amblyopia.
Browse Amblyopia studies →Yarmouk University is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Participants patched the fellow eye for 2 hours daily within the morning window of 07:00 to 10:00 for 6 months. During patching: child is encouraged to perform near-vision activities (e.g. reading, puzzles, coloring). Duration: 6 months (unless withdrawal criteria met).
Behavioral: eye-patching
Participants patched the fellow eye for 2 hours daily within the evening window of 17:00 to 20:00 for 6 months. During patching: same near-vision tasks as Arm 1. Duration: 6 months (unless withdrawal criteria met).
Behavioral: eye-patching
is a non-invasive treatment for Amblyopia ("lazy eye") in children. It involves covering (patching) the stronger, "good" eye so that the weaker (amblyopic) eye is forced to work. This encourages the brain to rely on the amblyopic eye, helping to strengthen its visual pathways.
Also known as: occlusion therapy
Change in best-corrected visual acuity (BCVA) of the amblyopic eye
Change in best-corrected visual acuity (BCVA) of the amblyopic eye from baseline to month 6, measured using a standardized logMAR (crowded) chart under full refractive correction, by a masked examiner.
Time frame: Baseline to Month 6
Adherence percentage reported by caregiver
For each participant, adherence was calculated as the cumulative patching time recorded within the assigned morning or evening treatment window divided by the cumulative prescribed patching time over the 6-month treatment period, expressed as a percentage. Higher percentages indicate greater adherence.
Time frame: Baseline through 6 months
Change From Baseline in Stereoacuity at Month 6
Stereoacuity was assesed using the titmus fly test and recorded in seconds of arc
Time frame: Baseline through month 6
At least 2-line improvement
Participants with a reduction of at least 0.20 logMAR from baseline to Month 6 were classified as achieving at least a 2-line improvement.
Time frame: Baseline and Month 6
Plan to share: Undecided
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Yarmouk University