Micro vs. Standard Trabeculectomy Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-03-31

Brief Summary

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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

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Standard Trabeculectomy

Patients in the Standard Trabeculectomy arm will undergo regular trabeculectomy

Group Type ACTIVE_COMPARATOR

Standard Trabeculectomy

Intervention Type PROCEDURE

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

Microtrabeculectomy

Patients in the Microtrabeculectomy arm will undergo microtrabeculectomy

Group Type EXPERIMENTAL

Microtrabeculectomy

Intervention Type PROCEDURE

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

Interventions

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Standard Trabeculectomy

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

Intervention Type PROCEDURE

Microtrabeculectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No