UNITY VCS Vitreoretinal Surgery: Randomized Comparative Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 260
- 试验地点
- 8
- 主要终点
- Percentage of vitreoretinal surgeries performed using 27-gauge consumables
研究概览
简要总结
This purpose of this study is to compare the safety and effectiveness of two eye surgery systems-UNITY VCS and CONSTELLATION-in treating adults with vitreoretinal diseases or disorders.
详细描述
Subjects will attend a total of 6 scheduled visits for an individual of participation of approximately 3 months. One eye (study eye) will be treated with either UNITY VCS or CONSTELLATION, as randomized.
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
- None
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
- •Requires surgery for a clinically documented posterior vitreoretinal medical condition.
- •Clear ocular media except for vitreous hemorrhage and floaters undergoing surgery.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Presence of clinically significant ocular or systemic diseases that may interfere with study outcomes or safety.
- •Diagnosis of glaucoma or suspected ocular hypertension.
- •Recent intraocular eye surgery, other than cataract surgery, resulting in retained lens materials in the posterior segment (within the past 3-months).
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
UNITY Vitreoretinal Cataract System (VCS)
Vitreoretinal ophthalmic surgery in one eye using UNITY Vitreoretinal Cataract System (VCS)
干预措施: UNITY Vitreoretinal Cataract System (VCS) (Device)
UNITY Vitreoretinal Cataract System (VCS)
Vitreoretinal ophthalmic surgery in one eye using UNITY Vitreoretinal Cataract System (VCS)
干预措施: Vitreoretinal ophthalmic surgery (Procedure)
CONSTELLATION Vision System
Vitreoretinal ophthalmic surgery in one eye using CONSTELLATION Vision System
干预措施: CONSTELLATION Vision System (Device)
CONSTELLATION Vision System
Vitreoretinal ophthalmic surgery in one eye using CONSTELLATION Vision System
干预措施: Vitreoretinal ophthalmic surgery (Procedure)
结局指标
主要结局
Percentage of vitreoretinal surgeries performed using 27-gauge consumables
时间窗: Day 0 operative
The surgeon will select the gauge size of the surgical consumables used for vitreoretinal surgery
次要结局
未报告次要终点