Divergence Excess/Simulated Divergence Excess Exotropia (DESDEE)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 9
- 主要终点
- Percent of participants reclassified as divergence excess exotropia
研究概览
简要总结
This study intends to determine the number and percent of subjects initially diagnosed with divergence excess exotropia which would be reclassified as simulated divergence excess exotropia if tested after 24 hours of monocular occlusion (patching) or after prism adaptation for the distance angle.
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
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with divergence excess exotropia according to standard criteria (see Study Procedures for specifics)
- •No prior strabismus surgery
- •Able to cooperate with testing (by examiner determination)
- •Neurologically normal except for strabismus (ADHD and autism spectrum are not
排除标准
- •as long as the subject can cooperate for necessary testing)
- •Not amblyopic at the time of enrollment (best-corrected visual acuity in both eyes of 20/40 or better)
- •Under 18 years of age. There is no lower age limit as long as the subject can cooperate for the required testing.
- •No diagnosis of dissociated vertical deviation
- •Exclusion Criteria:
- •No diagnosis of divergence excess exotropia according to standard criteria (see Study Procedures for specifics)
- •Prior strabismus surgery
- •Unable to cooperate with testing (by examiner determination)
- •Diagnosed with a neurological disorder (ADHD and autism spectrum are not exclusion criteria as long as the subject can cooperate for necessary testing)
- •Best-corrected visual acuity in either eye worse than 20/40
- •18 years of age or older
- •Diagnosed with dissociated vertical deviation
研究组 & 干预措施
Patching
干预措施: Patching (Procedure)
Prism Adaptation
干预措施: Prism Adaptation (Procedure)
结局指标
主要结局
Percent of participants reclassified as divergence excess exotropia
时间窗: 2 weeks
Percentage of patients with distance and near exotropia measurements within 2.5 prism diopters on alternate prism and cover testing after 24 hours of patching or 7-14 days of fresnel prism use.
Percent of participants reclassified as simulated divergence excess exotropia
时间窗: 2 weeks
Percentage of patients with distance and near exotropia measurements differing by more than 2.5 prism diopters on alternate prism and cover testing after 24 hours of patching or 7-14 days of fresnel prism use.
次要结局
未报告次要终点
研究者
Matthew Gearinger
Professor
University of Rochester