Morning Versus Evening Patching in Childhood Amblyopia

NCT07294599 | Completed

• 1 other identifier: IRB/2025/318
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Amblyopia

Keywords

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

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.

  Baseline to Month 6

Secondary Outcomes (3)

• Adherence percentage reported by caregiver

  Baseline through 6 months

• Change From Baseline in Stereoacuity at Month 6

  Baseline through month 6

• At least 2-line improvement

  Baseline and Month 6

Study Arms (2)

Morning patching

EXPERIMENTAL

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

Evening patching

EXPERIMENTAL

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

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

Study Sites (2)

Irbid Medical Consultation Center

Irbid, Irbid Governorate, 21163, Jordan

Location

Princess Basma teaching hospital

Irbid, Irbid Governorate, 21163, Jordan

Location

MeSH Terms

Conditions

Amblyopia; Strabismus; Anisometropia

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; Refractive Errors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Best-corrected visual-acuity assessments were performed by trained examiners who were not involved in patching instruction or adherence assessment and remained masked to treatment assignment throughout follow-up. Allocation was concealed using sequentially numbered, sealed envelopes opened only after eligibility confirmation and completion of the baseline assessment..
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Intervention model: Parallel-group randomized trial. Children with unilateral amblyopia were randomized 1:1 to morning patching, consisting of 2 hours daily within 07:00-10:00, or evening patching, consisting of 2 hours daily within 17:00-20:00. Participants remained in their assigned group for 6 months. Near-vision activities were encouraged during patching. Outcomes were assessed at baseline, Month 3, and Month 6. Randomization was stratified by age group, baseline amblyopic-eye BCVA category, and amblyopia type.⁷

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: December 14, 2025
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-08

Locations

JO (2)