Micro vs. Standard Trabeculectomy Study

University of California San Francisco (UCSF)

Status: Unknown

Conditions: Glaucoma

Treatments: Procedure: Standard Trabeculectomy; Procedure: Microtrabeculectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02598765

15-16075

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups

Standard Trabeculectomy

Active Comparator group

Description:

Patients in the Standard Trabeculectomy arm will undergo regular trabeculectomy

Treatment:

Procedure: Standard Trabeculectomy

Microtrabeculectomy

Experimental group

Description:

Patients in the Microtrabeculectomy arm will undergo microtrabeculectomy

Treatment:

Procedure: Microtrabeculectomy