Morning Versus Evening Patching in Childhood Amblyopia

NCT07294599 | Not Yet Recruiting

• 1 other identifier: IRB/2025/318
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Amblyopia

Keywords

Morning patching; Evening patching; Amblyopia; Clinical trial; Anisometriopia; Strabismus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• stereoacuity

  6 month

Study Arms (2)

Morning patching

EXPERIMENTAL

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

Evening patching

EXPERIMENTAL

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

Interventions

eye-patching BEHAVIORAL

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

Evening patching; Morning patching

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yarmouk University: lead

MeSH Terms

Conditions

Amblyopia; Strabismus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ocular Motility Disorders; Cranial Nerve Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments (visual acuity, stereoacuity, ocular alignment) will be performed by trained examiners (e.g., optometrists/orthoptists) who are not involved in randomization, patching-instructions, or adherence monitoring, and who will remain masked to the child's assignment (morning vs evening patching). Allocation will be concealed via a central computer-generated randomization list; the enrolling investigator will not communicate assignment to the assessor. Standard operating procedures (chart, lighting, refractive correction, instructions) will be used uniformly. Data entered in the database will use non-descriptive group codes ("Group A" / "Group B"), and the statistician will remain blinded until the database is locked and primary analysis is complete.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Intervention model: Parallel-group, randomized assignment. Children with unilateral amblyopia will be randomized 1:1 to one of two arms: (1) morning patching (08:00-10:00 daily) or (2) evening patching (17:00-19:00 daily). Participants remain in their assigned arm for the full 6-month study and receive 2 hours/day occlusion with near-vision tasks. Outcomes (visual acuity ± stereoacuity) are assessed at baseline, 3 months (midpoint), and 6 months (final). Stratified randomization (by age group 4-\<6 vs 6-8 years, baseline VA severity, and amblyopia type) ensures balanced prognostic variables across arms. The purpose is efficacy comparison - to determine whether timing of daily occlusion (morning vs evening) affects improvement in the amblyopic eye after 6 months.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: December 14, 2025
• Primary Completion (Estimated): June 14, 2026
• Study Completion (Estimated): June 14, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12