Micro vs. Standard Trabeculectomy Study

April 27, 2026 updated by: University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
      • Siddharthanagar, Nepal
        • Lumbini Eye Institute, Nepal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Trabeculectomy
Patients in the Standard Trabeculectomy arm will undergo regular trabeculectomy
Procedure: Standard Trabeculectomy
Fornix-based trabeculectomy with a 3x4 mm scleral flap.
Experimental: Microtrabeculectomy
Patients in the Microtrabeculectomy arm will undergo microtrabeculectomy
Procedure: Microtrabeculectomy
Fornix-based trabeculectomy with a 2x2 mm scleral flap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Seva Foundation
Lumbini Eye Institute and Research Centre

Investigators

  • Principal Investigator: Jeremy D Keenan, MD, MPH, F. I. Proctor Foundation, UCSF

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2016

Primary Completion (Actual)

July 21, 2020

Study Completion (Actual)

July 21, 2020

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (Estimated)

November 6, 2015

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-16075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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