A Prospective, Randomized, Comparative, MultiCenter Clinical Study to Assess the Safety and Effectiveness of the Transcend CyPass Glaucoma Implant in Patients With Open Angle Glaucoma Undergoing Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 897
- 主要终点
- Proportion of Eyes With ≥ 20% Decrease in Intraocular Pressure (IOP) From Baseline to the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the CyPass Implant for lowering intraocular pressure (IOP) in patients with glaucoma who undergo cataract surgery.
详细描述
This study is a modified and expanded protocol based on acceptable safety results from an earlier feasibility study. The trial is conducted using a 3:1 randomization (treatment to control) in which patients are screened for eligibility, randomized at time of surgery and followed for 24 months postoperatively.
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 (Participant)
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
- •Preoperative Inclusion Criteria:
- •Diagnosis of primary open angle glaucoma (POAG)
- •Mean diurnal unmedicated IOP of 21 - 33 mmHg
- •Normal anterior chamber angle anatomy at site of implantation
- •Operable age-related cataract
排除标准
- •Use of more than 3 ocular hypotensive medications (combination medications count as 2 medications)
- •Significant risk associated with washout of ocular hypotensive medication
- •Previous glaucoma surgery (with exception of laser treatments to the trabecular meshwork)
- •Previous corneal surgery
- •Clinically significant ocular pathology, other than cataract and glaucoma
- •Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic, pseudoexfoliative, pigmentary or neovascular glaucoma
研究组 & 干预措施
CyPass Micro-Stent + Cataract Surgery
Subjects receive the CyPass Micro-Stent at the conclusion of their cataract surgery
干预措施: Cataract Surgery (Procedure)
CyPass Micro-Stent + Cataract Surgery
Subjects receive the CyPass Micro-Stent at the conclusion of their cataract surgery
干预措施: CyPass Micro-Stent (Device)
Cataract Surgery Only
Subjects do not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
干预措施: Cataract Surgery (Procedure)
结局指标
主要结局
Proportion of Eyes With ≥ 20% Decrease in Intraocular Pressure (IOP) From Baseline to the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data
时间窗: Baseline; Month 24 postoperative
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Non-responders include subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.
次要结局
- Mean Change in IOP Between Baseline and Hypotensive Medication-free 24-month Postoperative Examination Using Baseline Value Imputation for Missing Data(Baseline; Month 24 postoperative)
- Proportion of Eyes With Postoperative IOP ≥ 6 and ≤ 18 mmHg, as Measured by Goldmann Tonometry, at the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data(Month 24 postoperative)