Novel Amblyopia Treatment With Dichoptic, Disparity-guided, Hand-Eye Coordination Enhanced, Serious, Virtual Reality Games
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Difference in Mean Change in Amblyopic Eye Visual Acuity
研究概览
简要总结
The goal of this study is to compare the change in amblyopic eye acuity between treatment periods in children with amblyopia, aged 5-17 years. The main question it aims to answer is:
Is a 16-week course of amblyopia treatment using Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for approx. 25 min/day, 6 days/week more effective for improvement in amblyopic-eye VA, binocularity (stereoacuity, suppression, alignment), contrast sensitivity, attention, oculomotor function, visual-motor integration, and quality of life than 16 weeks of continued glasses alone?
Participants will each serve as their own control and complete:
Treatment period 1: Continued optical correction (glasses) alone for 16 weeks; Treatment period 2: Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for 16 weeks (approx. 25min/day, 6 days/week) plus continued optical correction
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor will be masked to past performance and adherence.
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ages 5 to 17 years of age
- •Moderate to severe unilateral amblyopia (logMAR best corrected visual acuity 0.3 to 1.3) associated with anisometropia and/or strabismus of ≤5pd
- •Age normal VA in the nonamblyopic eye
- •Spectacle correction (if required) worn for at least 16 weeks, or until stability of VA is demonstrated (<0.1 logMAR change by the same testing method measured on 2 exams at least 8 weeks apart)
- •Interocular difference of ≥ 3 lines
- •No amblyopia treatment in the past 2 weeks
- •An interpupillary distance of 52-72 mm (inclusive)
排除标准
- •Myopia greater than -6.00 diopters (D) spherical equivalent in either eye.
- •Previous intraocular or refractive surgery.
- •Previous dichoptic treatment > 2 weeks in duration
- •Ocular co-morbidity that may reduce visual acuity determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met).
- •Diplopia more than once per week over the last week prior to enrollment by parental report.
- •Down syndrome or cerebral palsy.
- •Light-induced seizures
- •Known simulator sickness
- •Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities are not excluded.
结局指标
主要结局
Difference in Mean Change in Amblyopic Eye Visual Acuity
时间窗: Baseline to 16 weeks versus 16 weeks to 32 weeks
Optical correction worn for testing using Amblyopia Treatment Study (ATS) protocol; HOTV for ages 5-6 years; E-ETDRS for ages 7 years and older
次要结局
- Difference in Mean Change in Amblyopic-Eye Contrast Sensitivity(Baseline to 16 weeks versus 16 weeks to 32 weeks)
- Difference in Change in Stereoacuity/Binocularity(Baseline to 16 weeks versus 16 weeks to 32 weeks)
- Difference in Mean Change in reading eye movements(Baseline to 16 weeks versus 16 weeks to 32 weeks)
- Difference in Mean Change in Attention(Baseline to 16 weeks versus 16 weeks to 32 weeks)
- Difference in Mean Change in Pediatric Eye Questionnaire (PedEyeQ)(Baseline to 16 weeks versus 16 weeks to 32 weeks)
- Difference in Mean Change in visual-motor integration(Baseline to 16 weeks versus 16 weeks to 32 weeks)
研究者
Marjean Kulp
Professor
Ohio State University