NCT07054281撤回不适用
UNITY VCS Vitreoretinal Surgery: Randomized Comparative Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 260
- 试验地点
- 16
- 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.
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
研究者
研究点 (16)
Loading locations...
相似试验
撤回
不适用
A Cataract Surgery Clinical TrialCataractNCT07044674Alcon Research125
招募中
不适用
Minimal Vitrectomy Surgery for Epiretinal MembraneEpiretinal MembraneNCT07019896Peking Union Medical College Hospital140
Unknown
不适用
Economic aspect comparison between vitrectomy and scleral buckleEye DiseasesRetinal detachmentPACTR201703002136186Walid Ibrahim50
招募中
不适用
Comparison of vitrectomy outcomes for eyes with proliferative vitreoretinopathy with various silicon oil.proliferative vitreoretinopathyJPRN-UMIN000011739Department of Ophthalmology, Yamaguchi University Graduate School of Medicine100
已完成
不适用
Early VItrectomy in DENse Spontaneous Vitreous HEmorrhageSpontaneous Vitreous HemorrhageRetinal BreakRetinal DetachmentNCT04676256Assistance Publique - Hôpitaux de Paris8