Morning Versus Evening Patching in Childhood Amblyopia

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Amblyopia
• Intervention / Treatment: Behavioral: eye-patching

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: 4-8 years.
• Unilateral amblyopia.
• Amblyopic-eye BCVA decimal 0.17-0.67 (≈ 6/36-6/9).
• Fellow-eye BCVA ≥ 0.80 decimal (≈ 6/7.5 or better).
• Amblyopia type: refractive-dominant or strabismic/mixed.
• Parent/guardian consent obtained.

Exclusion Criteria:

• Bilateral amblyopia.
• Sensory-deprivation amblyopia (e.g., due to congenital cataract, ptosis, corneal opacity).
• Ocular surgery within the past 6 months, or planned surgery during study.
• Likely poor adherence (e.g., due to social, logistic, or family constraints).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Morning patching; Daily occlusion: 2 hours/day between 08:00-10:00. During patching: child performs near-vision activities (e.g. reading, puzzles, coloring). 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.; Other Names: occlusion therapy
Experimental: Evening patching; Daily occlusion: 2 hours/day between 17:00-19:00. 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.; Other Names: occlusion therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stereoacuity	Change in stereoacuity (arc-seconds unit) from baseline to Month 6 in amblyopic eye in the trial measured using the Titmus Fly Test	6 month

Collaborators and Investigators

• Sponsor: Yarmouk University

Study record dates

Study Major Dates

• Study Start (Estimated): December 14, 2025
• Primary Completion (Estimated): June 14, 2026
• Study Completion (Estimated): June 14, 2026

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Estimated): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Clinical trial; Strabismus; Amblyopia; Morning patching; Evening patching; Anisometriopia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Vision Disorders; Sensation Disorders; Cranial Nerve Diseases; Ocular Motility Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Amblyopia; Strabismus
• Other Study ID Numbers: IRB/2025/318

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No