Post Approval Study of the CyPass System in Patients With Primary Open Angle Glaucoma Undergoing Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 79
- 试验地点
- 22
- 主要终点
- Percentage of Eyes With Clinically Relevant Complications Associated With CyPass Micro-Stent Placement and Stability as Determined at Month 36
研究概览
简要总结
The purpose of this study is to demonstrate that the rate of clinically relevant complications associated with CyPass Micro-Stent placement and stability using the CyPass 241-S applier, as determined at 36 months in the postmarket setting, is less than the pre-specified performance target, which is based on experience with the CyPass Model E applier in COMPASS trial TMI-09-01 (NCT01085357).
详细描述
Each subject's expected participation in the study is up to 37.5 months which includes up to 42 days between the screening and surgery visits, and 36 months of post-surgery follow-up. Only one eye per subject will be implanted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Able to understand the requirements of the study and willing to follow study instructions, provide written informed consent, and agree to comply with all study requirements, including the required study follow-up visits
- •Diagnosis of primary open angle glaucoma (POAG)
- •Medicated intraocular pressure (IOP) of ≥10 millimeters mercury (mmHg) and ≤25 mmHg, or an unmedicated IOP of ≥21 mmHg and ≤33 mmHg
- •An operable age-related cataract eligible for phacoemulsification
- •Visual acuity as specified in the protocol
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Inability to complete a visual field test prior to surgery
- •Use of ocular hypotensive medication/s, as specified in the protocol
- •Diagnosis of glaucoma other than POAG, as specified in the protocol
- •Other medical conditions, as specified in the protocol
- •Proliferative diabetic retinopathy
- •Previous surgery for retinal detachment
- •Previous corneal surgery
- •Wet age-related macular degeneration
- •Poor vision in the non-study eye not due to cataract
- •Significant ocular inflammation or infection within 30 days of screening visit
- •Uncontrolled systemic diseases that may put the subject's health at risk and/or prevent the subject from completing all study visits
- •Women who are pregnant or nursing
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
CyPass System
CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery
干预措施: CyPass Micro-Stent implanted with CyPass 241-S applier (Device)
CyPass System
CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery
干预措施: Cataract surgery (Procedure)
结局指标
主要结局
Percentage of Eyes With Clinically Relevant Complications Associated With CyPass Micro-Stent Placement and Stability as Determined at Month 36
时间窗: Up to Month 36 postoperative
Device-related complications, as specified in the protocol, included: * Failure to implant CyPass, defined as inability to successfully deploy or insert the CyPass. * Clinically significant CyPass malposition, defined as CyPass positioning after deployment such that: * The device is not in the supraciliary space, or * Clinical sequela resulting from device position including, but not limited to: * Secondary surgical intervention to modify device position (eg, repositioning, proximal end trimming or explantation) * Corneal endothelial touch by device * Corneal edema leading to loss of BCDVA \> 2 lines at the last postoperative visit, in comparison with preoperative BCDVA * Progressive ECL, defined as ongoing reduction in endothelial cell count of 30% or more relative to the screening ECD value, where 'ongoing reduction in endothelial cell count' is defined as losses continuing after Visit 5 (6 Month Follow-up).
次要结局
- Percentage of Eyes With IOP Reduction 20 Percent or More From Baseline While Using the Same or Fewer Topical Ocular Hypotensive Medications at Month 36(Baseline, Month 36 postoperative)
- Mean Change in IOP From Baseline at Month 36(Baseline, Month 36 postoperative)
- Percentage of Eyes Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg at Month 36(Month 36 postoperative)
- Percentage of Eyes With Sight-threatening Adverse Events (AEs)(Up to Month 36 postoperative)
- Percentage of Eyes With Ocular Secondary Surgical Interventions (SSI)(Up to Month 36 postoperative)
- Percentage of Eyes With Ocular SSIs Associated With CyPass Placement and Stability(Up to Month 36 postoperative)