NCT04530084Unknown不适用
A Single Center Proof Of Concept Study To Assess Intra And Perioperative Safety Profile Of OMNI Surgical System
Mark Gallardo, MD2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年8月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Adverse events (intraoperative and perioperative)
研究概览
简要总结
The overall objective of this study is to determine the safety and usability of OMNI surgical system in performing canaloplasty and trabeculotomy. Outcome measures will include 1) adverse events (intraoperative and perioperative) 2) BCVA 3) Secondary surgical interventions 4) mean IOP and 5) mean number of hypotensive medications
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female subjects, 22 years or older.
- •Visually significant cataract or pseudophakic with a posterior chamber intraocular lens (PCIOL)
- •Diagnosed with open angle glaucoma (e.g. primary open angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma)
- •Scheduled for canaloplasty and trabeculotomy
排除标准
- •Any other intraocular surgery at the time of canaloplasty and trabeculotomy excepting cataract surgery for those subjects with cataract.
- •Prior trabeculectomy, other bleb-forming glaucoma surgery (e.g. tube shunt), or implanted trabecular bypass stents.
- •Any other ocular pathologies that may interfere with the study procedure or be exacerbated by the OMNI procedure.
结局指标
主要结局
Adverse events (intraoperative and perioperative)
时间窗: 3 months
Best Corrected Visual Acuity (BCVA)
时间窗: 3 months
次要结局
- Mean intraocular pressure (IOP)(3 months)
- Mean number of ocular hypotensive medications(3 months)
研究者
Mark Gallardo, MD
Principal Investigator
El Paso Eye Surgeons
研究点 (2)
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