Randomized Controlled Trial Evaluating AmblyoFix for the Treatment of Unilateral Amblyopia in Children, Teenagers and Young Adults Aged 8-19
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in BCVA in the amblyopic eye from baseline to Week 24
研究概览
简要总结
This is a prospective, randomized, parallel-group, assessor-masked, non-inferiority clinical trial designed to compare the efficacy, safety, and adherence of AmblyoFix binocular digital therapy with standard occlusion (patching) for the treatment of unilateral amblyopia in children and young adults aged 8 to 19 years. In the event that adequate recruitment within this age range is not feasible, the age range may be modified, subject to appropriate ethical approval and protocol amendment procedures.
A total of 40 participants were enrolled. Eligible participants will be randomized in a 1:1 ratio to receive either AmblyoFix or patching, stratified by age group and amblyopia severity. Randomization will be implemented using the sealed opaque envelope method, with allocation concealment maintained through sequentially numbered, tamper-proof envelopes.
The primary outcome is the change in amblyopic-eye best-corrected visual acuity (BCVA, logMAR) from baseline to 24 weeks, assessed under standardized Snellen or ETDRS protocol. Secondary outcomes include adherence, safety, and patient-reported outcomes. No interim analysis was conducted, as the trial concluded prior to reaching the 12-week time point.
Participants and caregivers cannot be blinded due to the nature of the interventions; however, outcome assessors and statisticians will remain blinded to treatment allocation to minimize bias. Follow-up assessments were conducted at baseline and 4 weeks, representing the time points with complete and reliable data across enrolled participants.
This trial aimed to rigorously determine whether AmblyoFix is a safe, effective, and non-inferior alternative to standard patching, with the potential to improve adherence and acceptability in amblyopia therapy.
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)
入排标准
- 年龄范围
- 8 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 8-19 years.
- •Unilateral amblyopia secondary to anisometropia, strabismus, or mixed.
- •BCVA in amblyopic eye between 20/40-20/400 (0.3-1.3 logMAR); fellow eye ≥20/32 (≤0.2 logMAR).
- •Interocular difference ≥2 lines (≥0.2 logMAR).
- •Stable refractive correction for ≥16 weeks or <0.1 logMAR change across two visits ≥8 weeks apart.
- •Cycloplegic refraction within 7 months meeting anisometropia criteria (e.g., hyperopia ≥+2.50 D).
- •Access to a suitable home environment (laptop and internet) for AmblyoFix arm.
- •Parent/guardian consent and child assent (8+ year olds).
排除标准
- •Atropine use within 2 weeks before starting treatment
- •Prior amblyopia treatment beyond refractive adaptation.
- •Myopia >-6.00 D SE, previous ocular surgery, or other ocular pathology.
- •Severe cognitive/developmental delay impeding compliance.
- •History of light-induced seizures.
- •Inability/unwillingness to comply with digital monitoring.
- •Any condition compromising safety or trial integrity.
研究组 & 干预措施
AmblyoFix
Participants assigned to this arm will undergo binocular vision therapy using the AmblyoFix software on a laptop, in combination with red-blue anaglyph glasses. Prior to therapy initiation, a calibration process will be completed and validated by the study team to ensure device screen specifications meet protocol requirements. Treatment consists of interactive, gamified visual tasks designed to stimulate the amblyopic eye under binocular viewing conditions. Participants will complete 90 minutes of therapy per day, six days per week, for 24 weeks. The software includes adaptive difficulty adjustments, automated usage logging for compliance monitoring, and a daily lockout feature to prevent overuse. Parents/guardians will receive training materials to support session supervision and problem reporting.
干预措施: AmblyoFix binocular digital therapy (Behavioral)
Patching (standard occlusion)
Participants assigned to this arm will receive standard occlusion therapy consisting of patching the non-amblyopic eye for 2 hours per day, six days per week, over a 24-week period, while continuing to wear spectacles full time. Caregivers will be trained to correctly apply and monitor patching, maintain daily patching logs documenting hours patched and any issues, and identify signs of intolerance. Patching logs will be reviewed by investigators during scheduled follow-up visits.
干预措施: Occlusion therapy (Patching) (Behavioral)
结局指标
主要结局
Change in BCVA in the amblyopic eye from baseline to Week 24
时间窗: From enrollment to 4 Weeks
The primary outcome of this trial is the change in best-corrected visual acuity (BCVA) in the amblyopic eye from baseline to week 24, measured in logMAR units using the Snellen or ETDRS protocol. This approach was selected for its clinical validity, reproducibility, and alignment with international standards in amblyopia trials, particularly for the study's target population of individuals aged 8-19 years. Visual acuity will be assessed monocularly under best optical correction, with the fellow eye occluded during testing. Certified, masked outcome assessors will conduct all measurements in standardized conditions to minimize bias, with testing procedures (including lighting, calibration, and display specifications) harmonized. Assessments were conducted at baseline and at 4 weeks, representing the time points with complete and reliable data across enrolled participants.
Change in BCVA in the amblyopic eye from baseline to Week 24
时间窗: From enrollment to the end of treatment at 24 Weeks
The primary outcome of this trial is the change in best-corrected visual acuity (BCVA) in the amblyopic eye from baseline to week 24, measured in logMAR units using the Snellen or ETDRS protocol. This approach was selected for its clinical validity, reproducibility, and alignment with international standards in amblyopia trials, particularly for the study's target population of individuals aged 8-35 years. Visual acuity will be assessed monocularly under best optical correction, with the fellow eye occluded during testing. Certified, masked outcome assessors will conduct all measurements in standardized conditions to minimize bias, with testing procedures (including lighting, calibration, and display specifications) harmonized. Assessments will occur at baseline and at follow-up visits scheduled every 4 weeks during the 24-week intervention period, to monitor durability of treatment effects.
次要结局
- Adherence to AmblyoFix(From enrollment to 4 Weeks)
- Adherence to occlusion therapy(From enrollment to 4 Weeks)
- Safety of Amblyofix(From enrollment to 4 Weeks)
- Adherence to AmblyoFix(From enrollment to the end of treatment at 24 Weeks)
- Adherence to occlusion therapy(From enrollment to Week 24)
- Safety of Amblyofix(From enrollment to the end of treatment at 24 Weeks)
- Patient Satisfaction(From enrollment to the end of treatment at 24 Weeks)