NCT04440527Unknown不适用
Intraocular Pressure After Preserflo /Innfocus Microshunt vs Trabeculectomy: a Prospective, Randomised Control-trial (PAINT-Study)
Medical University Innsbruck2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年7月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Difference in intraocular pressure
研究概览
简要总结
The aim of this project is to compare trabeculectomy with Preserflo / Innfocus Microshunt in patients with Primary Angle Open Glaucoma and Pseudoexfoliation Glaucoma regarding the reduction of intraocular pressure.
详细描述
The study is a prospective, randomized, monocentric, part blinded, controlled non-inferiority study of glaucoma patients.
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 (Investigator)
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
- •Age ≥ 18 years
- •Primary open angle glaucoma or pseudoexfoliation glaucoma
- •medically uncontrollable intraocular pressure or intolerance of topical therapy
- •negative urine/serum pregnancy test of women in childbearing age
- •signed and dated informed consent
排除标准
- •previous incisional glaucoma procedure on affected eye
- •pregnancy, nursing period
- •Patients in military service, training periods and civil service
- •Participation in another clinical trail
- •pre-existing ocular pathologies: high myopia (refraction ≥8.00 D), thin conjunctiva
结局指标
主要结局
Difference in intraocular pressure
时间窗: 1 year
The primary endpoint is the difference between intraocular pressure after microshunt implantation vs trabeculectomy.
次要结局
未报告次要终点
研究者
研究点 (2)
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