临床试验/NCT01498224

NCT01498224已完成3 期

ReSure Sealant Pivotal Study

Ocular Therapeutix, Inc.2 个研究点分布在 1 个国家目标入组 488 人开始时间: 2011年12月最近更新: 2016年12月12日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Ocular Therapeutix, Inc.
入组人数: 488
试验地点: 2
主要终点: Proportion of eyes with any clear corneal incision/suture leakage as determined by positive Seidel test indicating fluid egress within first 7 days after surgery.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a randomized multicenter study to evaluate the safety and effectiveness of ReSure Sealant compared to sutures for preventing incision leakage within the first 7 days of cataract surgery.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Single (Participant)

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 cornea cataract surgery with phacoemulsification and implantation of posterior chamber intraocular lens
•Subject must be 22 years of age or older

排除标准

•Any intraocular inflammation in study eye or presence of ocular pain in operative eye at preoperative assessment
•Previous corneal or retinal surgery or planned multiple procedures during cataract surgery.

结局指标

主要结局

Proportion of eyes with any clear corneal incision/suture leakage as determined by positive Seidel test indicating fluid egress within first 7 days after surgery.

时间窗: Days 1-28

次要结局

Foreign Body Sensation(Days 1-28)
Best corrected visual acuity(Day 28)

研究者

发起方

Ocular Therapeutix, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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