FIVE-YEAR POSTOPERATIVE OUTCOMES IN PATIENTS WITH OPEN-ANGLE GLAUCOMA WHO UNDERWENT BIO-INTERVENTIONAL UVEOSCLERAL OUTFLOW ENHANCEMENT SURGERY: LONG-TERM OBSERVATIONAL FOLLOW-UP FROM THE CREST STUDY (THE CREST-XT STUDY)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 250
- 试验地点
- 10
- 主要终点
- Mean change in intraocular pressure (IOP)
研究概览
简要总结
This study is designed to collect clinical data at 3, 4, and 5 years postoperatively for participants who completed the CREST Study without having secondary IOP-lowering surgery in the study eye(s).
详细描述
This is a multicenter, prospective, observational study following eligible participants who completed the CREST Study. Participants who consent to participate will have clinical data gathered from annual ophthalmic examinations through 60 months after CycloPen System surgery for analysis of long-term outcomes. As an observational study, examinations at each visit are performed per the investigator's standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of open-angle glaucoma (OAG) in the study eye(s), including pigmentary and pseudoexfoliative glaucoma, at the time of CREST enrollment
- •Completed participation in CREST
- •Provide signed written consent using the Institutional Review Board (IRB)/Ethics Committee (EC) approved study-specific informed consent form (ICF)
- •Ability, comprehension, and willingness to follow study instructions
排除标准
- •Systemic disease that, in the opinion of the Investigator, would put participant's health at risk and/or prevent completion of required study visits
- •Early termination from CREST
- •Secondary surgical intervention for long-term IOP control in the study eye(s)
研究组 & 干预措施
Bio-reinforced Cyclodialysis alone
Bio-reinforced cyclodialysis is performed using the CycloPen Cyclodialysis System
干预措施: CycloPen Micro-Interventional Cyclodialysis System (Procedure)
Bio-reinforced Cyclodialysis in conjunction with cataract surgery
Cataract surgery is performed, then followed by bio-reinforced cyclodialysis using the CycloPen Cyclodialysis System
干预措施: CycloPen Micro-Interventional Cyclodialysis System Post Cataract (Procedure)
结局指标
主要结局
Mean change in intraocular pressure (IOP)
时间窗: From before bio-interventional cyclodialysis to 60 months after surgery
Mean change in intraocular pressure (IOP) measured using tonometry
次要结局
未报告次要终点