A Randomized Clinical Trial of ab Interno Canaloplasty and Trabeculotomy With the OMNI Surgical System Compared to Standard Medical Treatment as a Standalone Procedure in Patients With Primary Open Angle Glaucoma
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Subjects with a ≥ 20% reduction
研究概览
简要总结
A Randomized Clinical Trial of Ab Interno Canaloplasty and Trabeculotomy with the OMNI® Surgical System Compared to Standard Medical Treatment as a Standalone Procedure in Patients with Primary Open Angle Glaucoma (EVOLVE)
详细描述
This prospective, multicenter, post-market clinical trial will evaluate the safety and effectiveness of canaloplasty and trabeculotomy using the OSS as a standalone procedure in patients with POAG.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, 45 years or older.
- •History of uncomplicated cataract surgery and posterior chamber intraocular lens (IOL) implantation without compromise to the lens capsule, zonular dehiscence/rupture or vitreous prolapse, 6 months or more prior to Baseline Visit (pseudophakic subjects), OR, phakic and no anticipated need for cataract surgery over the study duration.
- •Under treatment with a topical prostaglandin F2 analog (e.g. latanoprost, travoprost, bimatoprost, tafluprost) either as monotherapy or in combination with one (1) adjunctive medication for a minimum of 6 weeks prior to the Screening visit.
- •Intraocular pressure (IOP) at the Screening visit of >18 and not exceeding 36 mmHg.
- •Diagnosed with primary open angle glaucoma (POAG).
排除标准
- •Any of the following prior ocular procedures:
- •Laser trabeculoplasty ≤180 days prior to baseline
- •Durysta ≤12 months prior to baseline unless failure is documented and topical medication including a prostaglandin analog is in use as per Inclusion criterion #
- •Implanted with iStent (All types), Cypass, Xen, Express, glaucoma draining device/valve, or Hydrus Device; or
- •Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, endoscopic cyclophotocoagulation (ECP), Cyclophotocoagulation or CPC (G probe)
- •Retinal laser procedure ≤3 months prior to baseline
- •Concurrent IOP-lowering procedure other than the study procedure (OSS) (e.g. ECP, CPC,etc.)
- •Forms of glaucoma other than POAG including but not limited to: Pigmentary, pseudoexfoliative, acute angle closure, normal tension, pre-perimetric, traumatic, congenital, malignant, uveitic, neovascular or severe glaucoma as documented in subject's medical record.
- •Women of childbearing potential if they are currently pregnant or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study
研究组 & 干预措施
Surgical (OMNI Surgical System (OSS))
Canaloplasty followed by Trabeculotomy using the OMNI Surgical System.
干预措施: OMNI Surgical System (Device)
Standard Medical Care (SMC)
Standard Medical Care with Latanoprost and one or two adjunctive glaucoma medications at the discretion of the Principal Investigator
干预措施: Latanoprost plus adjunctive glaucoma medication (Drug)
结局指标
主要结局
Subjects with a ≥ 20% reduction
时间窗: 12 months
Proportion of subjects with a ≥ 20% reduction from medicated baseline in mean diurnal IOP (DIOP) at 12 months post-operatively
次要结局
- Corneal or conjunctival staining(12 months)
- Number of Ocular Hypotensive Medications(12 months)
- Diurnal IOP (DIOP) between 6 and 18 mmHg (inclusive)(12 months)
- Tear break-up time (TBUT)(12 months)
- OSDI score(12 months)