Micro vs. Standard Trabeculectomy Study

NCT02598765 — Not applicable, Completed, 100 participants, University of California, San Francisco

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Registry	NCT02598765
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	100 (Actual)
Sponsor	University of California, San Francisco (Other); collaborators: Seva Foundation, Lumbini Eye Institute and Research Centre
Conditions	Glaucoma
Interventions	Standard Trabeculectomy, Microtrabeculectomy (Procedure)
Dates	start 2016-04-04, primary completion 2020-07-21, completion 2020-07-21, first posted 2015-11-06, last updated 2026-05-01
Locations	1 site in Nepal

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Standard Trabeculectomy	Active comparator	Procedure: Standard Trabeculectomy	Patients in the Standard Trabeculectomy arm will undergo regular trabeculectomy
Microtrabeculectomy	Experimental	Procedure: Microtrabeculectomy	Patients in the Microtrabeculectomy arm will undergo microtrabeculectomy

Standard Trabeculectomy (Procedure): Fornix-based trabeculectomy with a 3x4 mm scleral flap.
Microtrabeculectomy (Procedure): Fornix-based trabeculectomy with a 2x2 mm scleral flap.

+Outcome measures

Primary outcomes

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 outcomes

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
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 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

+Eligibility

Sex: All, ages: 40 Years to any

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

+Locations (1)

Facility	City	Country	Status
Lumbini Eye Institute, Nepal	Siddharthanagar	Nepal

+Investigators

Jeremy D Keenan, MD, MPH, Principal investigator, F. I. Proctor Foundation, UCSF