Multi-Center Prospective Randomized Controlled Study of the Safety and Effectiveness of the Sight Sciences VISCO™360 System in Canaloplasty vs Selective Laser Trabeculoplasty in the Reduction of IOP in Primary Open Angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 12
- 主要终点
- Mean Change From Baseline in Diurnal IOP at 12 Months (Measured in mm Hg)
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the Sight Sciences VISCO™360 Viscosurgical System in reducing intraocular pressure (IOP) in adult, pseudophakic subjects with open-angle glaucoma.
详细描述
This is a randomized study comparing viscodilation with the VISCO360 device to selective laser trabeculoplasty. Subjects with mild to moderate primary open-angle glaucoma undergo IOP-lowering medication washout at baseline and at Month 12. Subjects will be followed through Month 24.
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 (Outcomes Assessor)
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
- •Diagnosed with primary open-angle glaucoma (POAG) in the study eye.
- •Pseudophakic with Posterior Chamber IOL (PCIOL)
- •Able and willing to attend follow up visits for two years post-operative
- •Able and willing to sign informed consent
排除标准
- •Phakia or aphakia
- •Previous glaucoma procedure with or without an implantable glaucoma device (including incisional surgery, ALT, iridectomy/iridotomy, etc.) [Subjects with one prior SLT application (>3 months prior to screening) or prior ECP (performed > 12 months prior to screening) can be enrolled].
- •Use of more than 3 ocular hypotensive medications (combination medications count as 2 medications)
- •Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic, pseudoexfoliative, pigmentary or neovascular glaucoma
- •Abnormal angle anatomy as determined by gonioscopy (e.g. peripheral anterior synechiae, rubeosis or other angle abnormalities)
- •Participation in any clinical trial ≤ 30 days prior to screening
研究组 & 干预措施
VISCO360 ab interno canaloplasty surgery
Subjects randomized to this arm will undergo a surgical procedure in which the VISCO360 Viscosurgical System will be used to microcatheterize and viscodilate Schlemm's canal (i.e., canaloplasty).
干预措施: VISCO360 ab interno canaloplasty surgery (Device)
Selective Laser Trabeculoplasty (SLT)
Subjects randomized to this arm will undergo the SLT procedure.
干预措施: Selective Laser Trabeculoplasty (SLT) (Device)
结局指标
主要结局
Mean Change From Baseline in Diurnal IOP at 12 Months (Measured in mm Hg)
时间窗: 12 months
The mean of the difference between the baseline DIOP and the 12 month DIOP for each subject. Measurements at baseline and 12 months are following wash-out of glaucoma medication.
次要结局
- Proportion of Subjects Achieving a ≥ 20% Change in Mean Diurnal IOP at 12 Months(12 months)