Micro vs. Standard Trabeculectomy Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Cumulative incidence of complications
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age >= 40
- •Planning to have a trabeculectomy
Exclusion Criteria
- •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
Arms & Interventions
Standard Trabeculectomy
Patients in the Standard Trabeculectomy arm will undergo regular trabeculectomy
Intervention: Standard Trabeculectomy (Procedure)
Microtrabeculectomy
Patients in the Microtrabeculectomy arm will undergo microtrabeculectomy
Intervention: Microtrabeculectomy (Procedure)
Outcomes
Primary Outcomes
Cumulative incidence of complications
Time Frame: 3 months after surgery
Comparison of the cumulative incidence of complications between the treatment groups (regular and micro trabeculectomy) 3 months after surgery
Secondary Outcomes
- 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)
Investigators
Jeremy Keenan
Associate Professor
University of California, San Francisco