Micro vs. Standard Trabeculectomy Study

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
Micro vs. Standard Trabeculectomy Study

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Procedure: Standard Trabeculectomy
* Procedure: Microtrabeculectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of complications | 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 | 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 | 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 | Reduction of intraocular pressure 6 months and 12 months after surgery will be compared between the treatment groups | 6 and 12 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Trabeculectomy, Eye Disease, Intraocular Pressure, Visual Acuity