Glaucoma
Conditions
Keywords
Glaucoma, Trabeculectomy, Eye Disease, Intraocular Pressure, Visual Acuity
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.
Interventions
PROCEDUREStandard Trabeculectomy
Fornix-based trabeculectomy with a 3x4 mm scleral flap.
PROCEDUREMicrotrabeculectomy
Fornix-based trabeculectomy with a 2x2 mm scleral flap.
Sponsors
University of California, San Francisco
Seva Foundation
Lumbini Eye Institute and Research Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of complications | 3 months after surgery | Comparison of the cumulative incidence of complications between the treatment groups (regular and micro trabeculectomy) 3 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in intraocular pressure | 3 months after surgery | Comparison of the reduction in intraocular pressure between the treatment groups (regular and micro trabeculectomy) 3 months after surgery |
| Cumulative incidence of complications | 6 and 12 months after surgery | Cumulative incidence of complications 6 months and 12 months after surgery will be compared between the treatment groups |
| Reduction of intraocular pressure | 6 and 12 months after surgery | Reduction of intraocular pressure 6 months and 12 months after surgery will be compared between the treatment groups |
Countries
Nepal
Contacts
PRINCIPAL_INVESTIGATORJeremy D Keenan, MD, MPH
F. I. Proctor Foundation, UCSF
Outcome results
None listed