Binocular Amblyopia Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in visual acuity of the amblyopic eye
研究概览
简要总结
To evaluate the effectiveness of enhanced binocular amblyopia treatments in achieving a more complete and stable recovery.
详细描述
To date, all studies of contrast-rebalanced binocular amblyopia treatment games used the same 10% per day contrast-increment that was designed for short-term intervention studies lasting 1-4 weeks; i.e., after 18 days of successful game play, both eyes viewed 100% contrast (no contrast-rebalancing).This study will investigate two alternative protocols designed to extend the game treatment period beyond 4 weeks to allow for more complete recovery of visual acuity. The new protocols will be compared with the original 10% contrast-increment game protocol in an 8-week 3-arm RCT to determine whether one or both of the new protocols is more effective than the current 10% increment.
Based on pilot data, we expect about 40% of amblyopic children to achieve normal visual acuity in 8 weeks. In an effort to also promote recovery of binocular vision, children who attain ≤0.4 logMAR at 8 weeks will be enrolled in stereoacuity training at the 8-week visit for the next 4 weeks. Children with residual amblyopia (BCVA >0.4 logMAR) at the 8-week visit will be provided with dichoptic movies for additional amblyopia treatment for another 4 weeks.
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
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 4-10 y
- •male and female
- •strabismic, anisometropic, or combined mechanism amblyopia
- •amblyopic eye best-corrected visual acuity 0.3-0.8 logMAR
- •fellow eye best-corrected visual acuity ≤0.1 logMAR
- •interocular visual acuity difference ≥0.3 logMAR
- •wearing glasses (if needed) for 8 weeks or no change visual acuity with glasses at 2 visits
- •4 weeks apart.
- •child's ophthalmologist and family must be willing to forgo patching treatment during the 12-week study period
- •parent's informed consent
- •child must demonstrate understanding and ability to play binocular games
排除标准
- •prematurity ≥8 weeks
- •coexisting ocular or systemic disease
- •developmental delay
- •strabismus >5pd
- •any binocular amblyopia treatment in the past 3 months
研究组 & 干预措施
Standard Contrast Increment
干预措施: Binocular games for treatment of amblyopia (Other)
Reduced Contrast Increment
干预措施: Binocular games for treatment of amblyopia (Other)
No Contrast Increment
干预措施: Binocular games for treatment of amblyopia (Other)
结局指标
主要结局
Change in visual acuity of the amblyopic eye
时间窗: baseline vs 8 weeks
ATS-HOTV for age 4-6.9 years or E-ETDRS for age 7-10.9 years
次要结局
- Change in visual acuity of the amblyopic eye(baseline vs 2, 4, 6, and 12 weeks)
- Change in stereoacuity(baseline vs 2, 4, 6, 8, 12 weeks)
- Change in suppression(baseline vs 2, 4, 6, 8, 12 weeks)
研究者
Eileen Birch
Senior Research Scientist
Retina Foundation of the Southwest