NCT07816692招募中不适用
Real-World Evidence Observational Study to Evaluate the Safety of iDose® TR (Travoprost Intracameral Implant) 75 µg in an Office-Based Surgery Setting
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Successful administration of iDose TR in an office-based surgical setting.
研究概览
简要总结
Clinical in-use observational trial to evaluate the administration of iDose TR (travoprost intracameral implant) in an office-based surgery setting.
详细描述
This study is a multicenter, single arm, open-label trial in adult subjects with open-angle glaucoma or ocular hypertension. The objective of the study is to assess the safety profile of iDose TR administration in an office-based surgery setting.
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
- •Diagnosis of Open angle glaucoma (OAG) or ocular hypertension (OHT)
排除标准
- •Prior administration of iDose TR or administration of an investigational intracameral implant in the study eye Active ocular infection or inflammation History of hypersensitivity to travoprost or implant components Recent ocular surgery Uncontrolled systemic disease Any condition preventing safe implantation
研究组 & 干预措施
iDose TR
Travoprost Intracameral Implant
干预措施: iDose TR (travoprost intracameral implant) 75 µg (Combination Product)
结局指标
主要结局
Successful administration of iDose TR in an office-based surgical setting.
时间窗: 3 months
Number of subjects that received iDose TR in an office-based surgical setting by the Investigator.
次要结局
未报告次要终点
研究者
研究点 (1)
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