Micro vs. Standard Trabeculectomy Study
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 4/12/2016 |
| Start Date: | November 2015 |
| End Date: | November 2016 |
| Contact: | Jeremy D Keenan, MD, MPH |
| Email: | Jeremy.Keenan@ucsf.edu |
| Phone: | 415-476-6323 |
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.
cumulative incidence of complications between the standard and micro trabeculectomy
surgeries 3 months after surgery.
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.
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.
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
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials