Rates and Risk Factors of Contact Between the OTX-TIC Intracameral Ocular Implant and Corneal Endothelium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary Outcome 1
研究概览
简要总结
To determine what proportion of patients have inferior angle recess dimensions that could accommodate the OTX-TIC, and what are risk factors for implant contact with the corneal endothelium.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age over 40 years
- •No history of ocular surgery other than cataract surgery
排除标准
- •- Media opacities that preclude OCT imaging of the anterior segment
结局指标
主要结局
Primary Outcome 1
时间窗: 4-6 Months
Predict contact between simulated OTX-TIC implant and corneal endothelium imaged using the ANTERION AS-OCT system.
Primary Outcome 2
时间窗: 4-6 Months
Characterize the variability in distance (mean and standard deviation) between the angle recess and Schwalbe's line
Primary Outcome 3
时间窗: 4-6 Months
Calculate the proportion of eyes with predicted contact between the simulated implant and corneal endothelium.
Primary Outcome 4
时间窗: 4-6 Months
Develop logistic regression models to identify demographic, clinical, and biometric risk factors for predicted contact.
次要结局
未报告次要终点
研究者
Benjamin Xu
Assistant Professor
University of Southern California