Micro vs. Standard Trabeculectomy Study

Not Applicable

• Conditions: Glaucoma
• Interventions: Procedure: Microtrabeculectomy; Procedure: Standard Trabeculectomy

• Registration Number: NCT02598765
• Lead Sponsor: University of California, San Francisco

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 Timeline

• Study First Submitted: 2015-11-04
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-06
• Study Start: 2016-03
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-06
• Last Update Posted: 2018-02-07
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microtrabeculectomy	Microtrabeculectomy	Patients in the Microtrabeculectomy arm will undergo microtrabeculectomy
Standard Trabeculectomy	Standard Trabeculectomy	Patients in the Standard Trabeculectomy arm will undergo regular trabeculectomy

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of complications	3 months after surgery	Comparison of the cumulative incidence of complications between the treatment groups (regular and micro trabeculectomy) 3 months after surgery

Secondary Outcome Measures

Name	Time	Method
Cumulative incidence of complications	6 and 12 months after surgery	Cumulative incidence of complications 6 months and 12 months after surgery will be compared between the treatment groups
Reduction in intraocular pressure	3 months after surgery	Comparison of the reduction in intraocular pressure between the treatment groups (regular and micro trabeculectomy) 3 months after surgery
Reduction of intraocular pressure	6 and 12 months after surgery	Reduction of intraocular pressure 6 months and 12 months after surgery will be compared between the treatment groups

Trial Locations

Locations (1)

Lumbini Eye Institute, Nepal; 🇳🇵 Siddharthanagar, Nepal