Morning Versus Evening Patching in Childhood Amblyopia-A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Change in best-corrected visual acuity (BCVA) of the amblyopic eye
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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..
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Evening 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).
干预措施: eye-patching (Behavioral)
Morning patching
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).
干预措施: eye-patching (Behavioral)
结局指标
主要结局
Change in best-corrected visual acuity (BCVA) of the amblyopic eye
时间窗: Baseline to Month 6
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.
Change in best-corrected visual acuity (BCVA) of the amblyopic eye
时间窗: 6 month
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.
次要结局
- stereoacuity(6 month)
- 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)
- stereoacuity(6 month)
研究者
Rami Alomari
Associate professor
Yarmouk University