Micro vs. Standard Trabeculectomy Study
概览
- 阶段
- 不适用
- 干预措施
- Standard Trabeculectomy
- 疾病 / 适应症
- Glaucoma
- 发起方
- University of California, San Francisco
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Cumulative incidence of complications
- 状态
- 已完成
- 最后更新
- 昨天
概览
简要总结
The purpose of this study is to determine the reduction in intraocular pressure and cumulative incidence of complications between the standard and micro trabeculectomy surgeries 3 months after surgery.
详细描述
This study is a randomized, double-masked (study participants and outcome assessors) trial. During the enrollment period, consecutive patients from LEI who are planning to have trabeculectomy surgery and who meet the study enrollment criteria will be randomized to receive standard trabeculectomy or microtrabeculectomy. The primary outcome is complications and change in intraocular pressure after a 3 month follow-up period. We will perform subgroup analyses by stratifying the population according to skin pigmentation to determine whether pigmentation is a predictor of treatment success.
研究者
Jeremy Keenan
Associate Professor
University of California, San Francisco
入排标准
入选标准
- •Age \>= 40
- •Planning to have a trabeculectomy
排除标准
- •Life threatening or debilitating disease
- •Inability to complete necessary exams and/or ocular disease that would preclude assessment of intraocular pressure, visual field, or optic disc
- •Contralateral eye already enrolled in study
研究组 & 干预措施
Standard Trabeculectomy
Patients in the Standard Trabeculectomy arm will undergo regular trabeculectomy
干预措施: Standard Trabeculectomy
Microtrabeculectomy
Patients in the Microtrabeculectomy arm will undergo microtrabeculectomy
干预措施: Microtrabeculectomy
结局指标
主要结局
Cumulative incidence of complications
时间窗: 3 months after surgery
Comparison of the cumulative incidence of complications between the treatment groups (regular and micro trabeculectomy) 3 months after surgery
次要结局
- Cumulative incidence of complications(6 and 12 months after surgery)
- Reduction in intraocular pressure(3 months after surgery)
- Reduction of intraocular pressure(6 and 12 months after surgery)