Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 6
- 主要终点
- Reduction in mean Intraocular Pressure (IOP) at 12 months compared to baseline
研究概览
简要总结
A prospective, multicenter, randomized, single-masked, post-market clinical trial comparing cataract surgery in conjunction with ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.) to cataract surgery only in patients with mild to moderate, primary open angle glaucoma. Subjects will be followed for 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate, primary open angle glaucoma
- •Characteristics consistent with mild to moderate glaucoma
- •Use of 1 - 4 ocular hypotensive medications at the Screening exam and meets the IOP (intraocular pressure) criteria
- •Visually significant cataract
排除标准
- •Any of the following prior treatments for glaucoma (study eye):
- •Laser Trabeculoplasty
- •Endocyclophotocoagulation (ECP) or Micropulse laser
- •iStent or iStent Inject
- •Hydrus Microstent
- •Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma drainage device/valve.
- •Prior canaloplasty (ab-interno and ab-externo)
- •Prior goniotomy, or trabeculotomy (ab-interno or ab-externo)
- •Suprachoroidal stent (e.g., Cypass, iStent Supra, XEN, MINIject)
- •Concurrent IOP-lowering procedure other than use of the iTrackTM Advance canaloplasty device at the time of surgery (e.g., ECP, CPC, etc.)
- •Previous treatment with iTrack (Note: permitted if fellow eye only was treated)
- •Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
研究组 & 干预措施
Cataract surgery combined with ab-interno canaloplasty
Ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.)
干预措施: Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device (Device)
Control: Cataract surgery
Cataract surgery alone
干预措施: Cataract surgery (Procedure)
结局指标
主要结局
Reduction in mean Intraocular Pressure (IOP) at 12 months compared to baseline
时间窗: 12 months
IOP will be measured at each study visit using Goldmann applanation tonometry
Reduction in number of glaucoma medications at 12 months compared to baseline
时间窗: 12 months
The number of glaucoma medications will be recorded at 12 months compared to baseline
次要结局
- Reduction in mean Intraocular Pressure (IOP) at 24-months compared to baseline(24 months)
- Reduction in glaucoma medications at 24-months compared to baseline(24 months)