ReSure Sealant Post-Approval Study: A Registry Evaluation of ReSure Sealant for Specified Adverse Ocular Events After Sealing Corneal Incisions in Patients Undergoing Clear Corneal Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 626
- 主要终点
- Anterior chamber cells greater than level 1+ persisting at Visit 2 (≥ Day 20)
研究概览
简要总结
This is a prospective multicenter observational post-approval registry study that will collect post-approval data relative to the incidence of pre-specified Adverse Ocular Events for cataract surgery patients treated with the FDA-approved ReSure Sealant when used by a broad group of physicians under commercial use conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a cataract and is expected to undergo clear corneal cataract surgery with intraocular lens placement
排除标准
- •ReSure Sealant is not applied to the operative eye
结局指标
主要结局
Anterior chamber cells greater than level 1+ persisting at Visit 2 (≥ Day 20)
时间窗: Post operative days 20 to 40
Hypotony (≤ 5 mmHg)
时间窗: Post operative days 20 to 40
Ocular discomfort
时间窗: Post operative days 20 to 40
Ocular Comfort Index score greater than 51.7 or a within-person increase from baseline of greater than 37.8
Surgical reintervention
时间窗: Post operative days 20 to 40
Surgical reintervention for management of a wound leak - Yes or No
次要结局
未报告次要终点