Glaucoma
Conditions
Keywords
Eye Disease, Intraocular Pressure, Visual Acuity, Trabeculectomy
Brief summary
This study is a randomized, double-masked trial to examine the response to trabeculectomy surgery. In this study, patients will be randomized to receive MMC via subconjunctival injection or topical sponge application.
Detailed description
This study is a randomized, double-masked (study participants and outcome assessors) trial. During the enrollment period, patients from Menelik Hospital who are planning to have trabeculectomy surgery and who meet the study enrollment criteria will be randomized to receive mitomycin C applied topically or by injection during the surgery.At Menelik Hospital mitomycin-C (MMC) is routinely applied to the eye prior to trabeculectomy by physicians via both sponge and injection routes. The primary outcome is the patient's response to the trabeculectomy procedure, as measured by cumulative complications after a 3-month follow-up period post-operation. Secondary outcome is the change in intraocular pressure after a 3 month follow-up period. The investigators will perform subgroup analyses by stratifying the population according to skin pigmentation to determine whether pigmentation is a predictor of treatment success.
Interventions
DRUGMitomycin-C (MMC)
Mitomycin-C is routinely applied to the eye prior to trabeculectomy at Menelik II Hospital
Sponsors
Menelik II Hospital
University of California, San Francisco
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 * Pseudophakic lens * 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 (MMC sponge and injection application) 3 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of complications | 6 and 12 months after surgery | Comparison of the cumulative incidence of complications between the treatment groups (sponge and injection application of MMC) 6 months and 12 months after surgery |
| Reduction of intraocular pressure from baseline, mmHg | 3, 6, and 12 months after surgery | The investigators will compare the reduction of IOP from baseline between the treatment groups at 3, 6, and 12 months after surgery |
Countries
Ethiopia
Outcome results
None listed