Micro vs. Standard Trabeculectomy Study

Glaucoma Clinical Trial

Official title:

Micro vs. Standard Trabeculectomy Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02598765
• Other study ID #: 15-16075
• Status: Recruiting
• Phase: N/A
• First received: November 4, 2015
• Last updated: February 6, 2018
• Start date: March 2016
• Est. completion date: March 2019

Study information

• Verified date: February 2018
• Source: Francis I. Proctor Foundation
• Contact: Jeremy D Keenan, MD, MPH
• Phone: 415-476-6323
• Email: Jeremy.Keenan[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

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

Locations

Country	Name	City	State
Nepal	Lumbini Eye Institute, Nepal	Siddharthanagar

Sponsors (3)

Lead Sponsor	Collaborator
Francis I. Proctor Foundation	Lumbini Eye Institute and Hospital, Seva Foundation

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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