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Completed

NCT Number: NCT02598765

Micro vs. Standard Trabeculectomy Study

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lumbini Eye Institute, Nepal

Siddharthanagar, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Trabeculectomy

Procedure

Fornix-based trabeculectomy with a 3x4 mm scleral flap.

Microtrabeculectomy

Procedure

Fornix-based trabeculectomy with a 2x2 mm scleral flap.

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Lumbini Eye Institute and Research Centre
  • Seva Foundation

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Nov 6, 2015
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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