A Prospective, Randomized, Multicenter Study To Compare The Safety And Effectiveness Of The OMNI® Surgical System And The iStent Inject In Pseudophakic Eyes With Open Angle Glaucoma. The TRIDENT European Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 10
- 主要终点
- Mean Change in Unmedicated DIOP From Baseline at the 12-month Postoperative Examination
研究概览
简要总结
First, to compare safety and effectiveness outcomes for canaloplasty and trabeculotomy using the OMNI Surgical System to implantation of the iStent inject in lowering intraocular pressure (IOP) in pseudophakic eyes with open angle glaucoma (OAG), and second, to compare safety and effectiveness outcomes for canaloplasty alone (using the OMNI Surgical System)to implantation of the iStent Inject in lowering IOP in pseudophakic eyes with OAG.
详细描述
A multicenter, prospective, parallel group study planned to randomize 459 subjects to either 1)canaloplasty + trabeculotomy with the OMNI, 2)canaloplasty alone with the OMNI, or 3)iStent inject in an equal allocation ratio (1:1:1); The study includes baseline and terminal (Month 12) washout. Up to 26 centers in the UK and EU were planned to participate.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, 18 years or older
- •Pseudophakic
- •Diagnosis of open angle glaucoma (OAG)
- •On 1-5 ocular hypotensive medications
排除标准
- •Any of the following prior treatments for glaucoma:
- •Suprachoroidal stent (e.g. Cypass, iStent Supra)
- •Laser trabeculoplasty ≤ 8 weeks prior to Baseline visit with a MIGS or other glaucoma device including but not limited to iStent, iStent inject, Hydrus, CyPass
- •Trabeculectomy or other bleb forming procedure including Xen, PreserFlo, Express, glaucoma draining device/valve
- •Prior canaloplasty, goniotomy, or trabeculotomy including procedures with GATT, Kahook Dual Blade, iTrack, Trabectome
- •Ciliary ablation procedures including Endocyclophotocoagulation (ECP), Cyclophotocoagulation (G probe), Micropulse laser, or high intensity focused ultrasound (HIFU)
- •Any other form of glaucoma other than OAG
- •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).
- •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
Mean Change in Unmedicated DIOP From Baseline at the 12-month Postoperative Examination
时间窗: 12 months
Mean change in unmedicated DIOP from baseline at the 12-month postoperative examination is the mean of the difference between the baseline DIOP and the Month 12 DIOP for each subject. Baseline and Month 12 DIOP are measured after appropriate washout of any glaucoma medications.
次要结局
未报告次要终点