A Prospective, Multi-center, Randomized, Masked, Controlled, Post-market Study Of Use Of The OMNI® Surgical System In Combination With Cataract Extraction In Open Angle Glaucoma (VERITA)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 4
- 主要终点
- Change in Unmedicated Diurnal Intraocular Pressure (DIOP)
研究概览
简要总结
To prospectively compare the clinical effect of the OMNI surgical system in eyes with Open Angle Glaucoma.
详细描述
First, to prospectively compare the clinical effect of the transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System to the iStent Inject used with Cataract Extraction in eyes with open angle glaucoma (OAG) and second, to prospectively compare the clinical effect of the transluminal viscoelastic delivery using the OMNI Surgical System to the iStent Inject used with Cataract Extraction in eyes with open angle glaucoma (OAG)
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
- 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
- •Mild to moderate open angle glaucoma
- •On 1-5 IOP-lowering medications
- •Potential of good best corrected visual acuity post cataract extraction, in the investigator's judgment
- •Able and willing to comply with the protocol, including all follow-up visits.
- •Understand and sign the informed consent.
排除标准
- •Any of the following prior treatments for glaucoma:
- •Laser trabeculoplasty ≤3 months prior to baseline
- •Implanted with iStent (All types), Cypass, Xen, Express, glaucoma draining device/valve, or Hydrus Device
- •Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, ECP or CPC
- •Acute angle closure, normal tension, traumatic, congenital, malignant, uveitic, neovascular or severe glaucoma as documented in subjects' medical record.
- •Concurrent ocular pathology or systemic medical condition which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period (e.g., wet AMD, corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits).
- •Participation (≤ 30 days prior to baseline) in an interventional trial which could have a potential effect on the study outcome, as determined by the study investigator
- •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.
结局指标
主要结局
Change in Unmedicated Diurnal Intraocular Pressure (DIOP)
时间窗: 1 week
The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.
次要结局
- Eyes With a ≥ 20% Decrease in Unmedicated Mean Diurnal Intraocular Pressure (DIOP) From Baseline(1 week)
- Change in the Number of Ocular Hypotensive Medications Compared to Screening(1 week)
- Change in Unmedicated Diurnal Intraocular Pressure (DIOP) From Baseline(1 week)
- Eyes With Unmedicated Diurnal Intraocular Pressure (DIOP) Between 6 and 18 mmHg Inclusive(1 week)