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Micro vs. Standard Trabeculectomy Study

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Standard Trabeculectomy
Microtrabeculectomy
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Trabeculectomy, Eye Disease, Intraocular Pressure, Visual Acuity

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Lumbini Eye Institute, NepalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Trabeculectomy

Microtrabeculectomy

Arm Description

Patients in the Standard Trabeculectomy arm will undergo regular trabeculectomy

Patients in the Microtrabeculectomy arm will undergo microtrabeculectomy

Outcomes

Primary Outcome Measures

Cumulative incidence of complications
Comparison of the cumulative incidence of complications between the treatment groups (regular and micro trabeculectomy) 3 months after surgery

Secondary Outcome Measures

Reduction in intraocular pressure
Comparison of the reduction in intraocular pressure between the treatment groups (regular and micro trabeculectomy) 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
Reduction of intraocular pressure
Reduction of intraocular pressure 6 months and 12 months after surgery will be compared between the treatment groups

Full Information

First Posted
November 4, 2015
Last Updated
February 6, 2018
Sponsor
University of California, San Francisco
Collaborators
Seva Foundation, Lumbini Eye Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02598765
Brief Title
Micro vs. Standard Trabeculectomy Study
Official Title
Micro vs. Standard Trabeculectomy Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
Collaborators
Seva Foundation, Lumbini Eye Institute and Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma, Trabeculectomy, Eye Disease, Intraocular Pressure, Visual Acuity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Trabeculectomy
Arm Type
Active Comparator
Arm Description
Patients in the Standard Trabeculectomy arm will undergo regular trabeculectomy
Arm Title
Microtrabeculectomy
Arm Type
Experimental
Arm Description
Patients in the Microtrabeculectomy arm will undergo microtrabeculectomy
Intervention Type
Procedure
Intervention Name(s)
Standard Trabeculectomy
Intervention Description
Fornix-based trabeculectomy with a 3x4 mm scleral flap.
Intervention Type
Procedure
Intervention Name(s)
Microtrabeculectomy
Intervention Description
Fornix-based trabeculectomy with a 2x2 mm scleral flap.
Primary Outcome Measure Information:
Title
Cumulative incidence of complications
Description
Comparison of the cumulative incidence of complications between the treatment groups (regular and micro trabeculectomy) 3 months after surgery
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
Reduction in intraocular pressure
Description
Comparison of the reduction in intraocular pressure between the treatment groups (regular and micro trabeculectomy) 3 months after surgery
Time Frame
3 months after surgery
Title
Cumulative incidence of complications
Description
Cumulative incidence of complications 6 months and 12 months after surgery will be compared between the treatment groups
Time Frame
6 and 12 months after surgery
Title
Reduction of intraocular pressure
Description
Reduction of intraocular pressure 6 months and 12 months after surgery will be compared between the treatment groups
Time Frame
6 and 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremy D Keenan, MD, MPH
Phone
415-476-6323
Email
Jeremy.Keenan@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Caitlin Moe, MS
Phone
415-502-2665
Email
Caitlin.Moe@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy D Keenan, MD, MPH
Organizational Affiliation
F. I. Proctor Foundation, UCSF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lumbini Eye Institute, Nepal
City
Siddharthanagar
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nanda Gurung, MD
Phone
00977-71-523827
Email
gurungn55@yahoo.com
First Name & Middle Initial & Last Name & Degree
Nanda Gurung, MD

12. IPD Sharing Statement

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Micro vs. Standard Trabeculectomy Study

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