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The necessary ethical approvals were not obtained in a timely manner.
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| Name | Class |
|---|---|
| Menelik II Hospital | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MMC Injection | Experimental | Intervention: At the intended surgical site and about 6mm from the limbus, 0.2ml of 0.2mg/ml of mitomycin-C (MMC) will be injected subconjunctivally before peritomy |
|
| MMC Sponge Application | Active Comparator | Intervention: After peritomy, three half-sponges soaked in 0.2mg/ml mitomycin-C (MMC) will be placed posterior to the area of intended filtration. After 2 minutes, the sponges will be removed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitomycin-C (MMC) | Drug | Mitomycin-C is routinely applied to the eye prior to trabeculectomy at Menelik II Hospital |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of complications | Comparison of the cumulative incidence of complications between the treatment groups (MMC sponge and injection application) 3 months after surgery | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of complications | Comparison of the cumulative incidence of complications between the treatment groups (sponge and injection application of MMC) 6 months and 12 months after surgery | 6 and 12 months after surgery |
| Reduction of intraocular pressure from baseline, mmHg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy D Keenan, MD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menelik II Hospital | Addis Ababa | Ethiopia |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
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| ID | Term |
|---|---|
| D016685 | Mitomycin |
| ID | Term |
|---|---|
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
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The investigators will compare the reduction of IOP from baseline between the treatment groups at 3, 6, and 12 months after surgery |
| 3, 6, and 12 months after surgery |
| D001389 |
| Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |