NCT07294599

Morning Versus Evening Patching in Childhood Amblyopia

Morning Versus Evening Patching in Childhood Amblyopia-A Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Yarmouk University · Academic / Other
• Sex: All
• Age: 4 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

To determine whether the time of day at which daily occlusion (patching) is administered - morning (08:00-10:00) versus evening (17:00-19:00) - affects the amount of 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.

Detailed description

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: Daily occlusion of the non-amblyopic eye for 2 continuous hours, at assigned time window (Morning: 08:00-10:00; Evening: 17:00-19:00). During patching, child engages in near-vision tasks (reading, puzzles, coloring) for 20-30 min or more. Adherence monitored via parent diary/photos. Spectacle correction (if prescribed) maintained throughout. 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 improvement, adherence rate (% of days/patching sessions completed). 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 / Power (Summary): Target total enrollment \~100 children (≈ 50 per arm), to provide sufficient power to detect a clinically meaningful difference (≈ 1 line difference in BCVA) between morning and evening patching, while allowing for variability, drop-outs, and stratified analyses. 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.

Conditions

• Amblyopia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-14
• Primary completion: 2026-06-14
• Completion: 2026-06-14
• First posted: 2025-12-19
• Last updated: 2025-12-26