Video Treatment for Amblyopia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in amblyopic eye visual acuity using a logMAR chart
研究概览
简要总结
The purpose of this study is to determine whether viewing asynchronous movies leads to better visual outcomes in young children with amblyopia than standard-of-care occlusion therapy with an adhesive patch and whether this is associated with better adherence to treatment.
详细描述
This is a single-site randomized clinical trial to compare treatment of amblyopia by viewing asynchronous movies to standard-of-care occlusion therapy with an adhesive patch. Participants will be referred from local pediatric ophthalmologists. Following informed consent, children will complete baseline testing to confirm eligibility and provide pre-treatment measurements of visual acuity, suppression, stereoacuity, motor skills, self-perception, and quality of life. Eligible children will then be randomly allocated to either patch-free occlusion therapy or standard-of-care occlusion therapy with an adhesive patch.
Children will participate in their assigned occlusion therapy at home for 6 weeks (primary outcome). Adherence will be objectively monitored. Vision will be re-assessed at 2 and 4 weeks and all tests will be repeated at 6 weeks. The asynchronous movie group will have an option to continue for and additional 2 or 4 weeks (10 weeks total). The standard-of-care occlusion group will be offered the opportunity to use the movie treatment at the 6 week visit through 10 weeks. Children who choose to remain in the study beyond the 6 week primary outcome visit will have vision reassessed at 8 and 10 weeks.
The primary analysis will be a comparison of improvement in amblyopic eye visual acuity (baseline-6 weeks) between the movie group and the standard-of-care patching group. Secondary analyses will include comparisons of adherence to each treatment, comparison of the proportion of children in each group with visual acuity ≤0.1 logMAR (recovered) at 6 weeks and 95% CIs, comparisons of changes in extent of suppression, depth of suppression, stereoacuity, motor skills standard scores, self-perception scores, and PedEyeQ domain scores. Associations among hours of treatment, changes in visual acuity, suppression, and stereoacuity, will be explored and modeled for dose-response relationships. In exploratory analyses, we will examine whether there are additional improvements in visual acuity, suppression, or stereoacuity between 6 and 10 weeks for the movie group (8 and 10 weeks means and 95% CIs).
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
- None
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 3-7 years
- •male and female
- •strabismic, anisometropic, or combined mechanism amblyopia (visual acuity 0.3-0.8 logMAR)
- •interocular visual acuity difference ≥0.3 logMAR
- •wearing glasses (if needed) for a minimum of 8 weeks with no change in visual acuity at 2 visits ≥4 weeks apart
- •child's ophthalmologist and family willing to forgo standard patching treatment during the study
排除标准
- •prematurity ≥8 wk
- •coexisting ocular or systemic disease
- •developmental delay
- •strabismus >5 pd
- •myopia > -3.00D
研究组 & 干预措施
Asynchronous movies
Asynchronous 3D movies
干预措施: Asynchronous 3D movies (Device)
Standard-of-care patching with an adhesive patch
Standard-of-care patching with an adhesive patch
干预措施: Patching (Device)
结局指标
主要结局
Change in amblyopic eye visual acuity using a logMAR chart
时间窗: 6 weeks
change in amblyopic eye logMAR visual acuity relative to baseline
次要结局
- Change in amblyopic eye visual acuity using a logMAR chart(2, 4, 8, and 10 weeks)
- Change in self perception assessed with the Pictorial Scale of Perceived Competence and Social Acceptance for Young Children(6 weeks)
- Change in quality of life assessed with the Pediatric Eye Questionnaire(6 weeks)
- Proportion of children who have recovered(2, 4, 6, 8, and 10 weeks)
- Adherence to patching measured with a sensor and adherence to viewing videos measured with the streaming log data(2,4, and 6 weeks)
- Change in extent suppression assessed with the W4 test(6 weeks)
- Change in motor skills assessed with the Movement Assessment Battery for Children -2(6 weeks)
- Change in depth of suppression assessed with the contrast balance index(6 weeks)
- Change in stereoacuity assessed with the Randot Preschool Stereoacuity Test(6 weeks)
研究者
Eileen Birch
Senior Research Scientist
Retina Foundation of the Southwest