Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Seva Foundation | OTHER |
| Lumbini Eye Institute and Research Centre | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Trabeculectomy | Active Comparator | Patients in the Standard Trabeculectomy arm will undergo regular trabeculectomy |
|
| Microtrabeculectomy | Experimental | Patients in the Microtrabeculectomy arm will undergo microtrabeculectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Trabeculectomy | Procedure | Fornix-based trabeculectomy with a 3x4 mm scleral flap. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cumulative incidence of complications |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeremy D Keenan, MD, MPH | F. I. Proctor Foundation, UCSF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lumbini Eye Institute, Nepal | Siddharthanagar | Nepal |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Microtrabeculectomy | Procedure | Fornix-based trabeculectomy with a 2x2 mm scleral flap. |
|
Cumulative incidence of complications 6 months and 12 months after surgery will be compared between the treatment groups
| 6 and 12 months after surgery |
| 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 |