Clinical Trial of OCT-based Scleral Lens Fitting With Wide-Field OCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Conjunctival Compression
研究概览
简要总结
The purpose of this study is to see if OCT technology can optimize scleral contact lens fittings. Subjects with keratoconus, post-penetrating keratoplasty (PK), post-LASIK ectasia, post-radial keratotomy (RK), or a variety of anterior surface disorders requiring scleral lens fittings will be considered for enrollment. For each study eye, a clinically-selected scleral lens fit will be compared against an OCT-selected lens fit. The quality of each lens fit will be determined by flourescein exam at the slit lamp. Apical clearance, limbal clearance, conjunctival compression, and lens edge lift will be assessed. A lens that satisfies all four criteria will be considered satisfactory.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eyes requiring fit for scleral lenses for KCN, post-PK, post-RK, post-LASIK ectasia, or various anterior surface disorders
排除标准
- •Inability to maintain stable fixation for OCT imaging
- •Inability to commit to required visits to complete the study
- •Eyes with concurrent retinal diseases, glaucoma, or other eye conditions that may limit visual outcome
结局指标
主要结局
Conjunctival Compression
时间窗: 5 years
Conjunctival compression of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable" or "excessive."
Lens Edge Lift
时间窗: 5 years
Lens edge lift for each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable" or "excessive."
Apical Clearance
时间窗: 5 years
Apical clearance of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable," "too high," or "too low."
Limbal Clearance
时间窗: 5 years
Limbal clearance of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable," "too much," or "too little."
次要结局
未报告次要终点
研究者
David Huang
Peterson Professor of Ophthalmology & Professor of Biomedical Engineering
Oregon Health and Science University