NCT05044793已完成不适用
A Multicenter Clinical Study To Assess The Long-Term Safety And Effectiveness Of The OMNI® Surgical System In Combination With Cataract Surgery In Eyes With Open Angle Glaucoma (GEMINI 2.0)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and effectiveness of the OMNI® Surgical System in subjects who were treated under protocol #06213
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participated in, received treatment, and completed Protocol #06213
排除标准
- •Systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent completion of required study visits
- •Ocular pathology which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate washout, place the subject at risk of significant vision loss during the study period (e.g., wet age macular degeneration (AMD), corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits)
结局指标
主要结局
Primary Safety Endpoint
时间窗: 12 months
Rate of occurrence of sight-threatening adverse events
次要结局
未报告次要终点
研究者
研究点 (4)
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