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Patients with advanced glaucoma that are candidates for trabeculectomy will be included.
Thorough ophthalmic examination including best corrected visual acuity, slit lamp examination, intraocular pressure (IOP) measurement, gonioscopy, funduscopy and specularly microscopy will be performed for all participants. Patients will be assigned randomly to 2 groups. In one group they will undergo fornix based trabeculectomy with conventional MMC 0.02% soaked sponges application. In the other group 0.1 cc of 0.01 MMC will be injected into the tenon at the beginning of the surgery. The rest of the operation is the same for both groups as standard trabeculectomy. Ophthalmic examination including IOP measurement will be performed at one, 3 and 6th month post surgery. Specular microscopy will be requested at final follow up visit. Bleb morphology will be scored according to Indian grading system at 3rd and 6th months post surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| using standard method of applying MMC | Active Comparator | applying MMC 0.02 % soaked sponges under conjunctival space for 1 to 3 minutes |
|
| intratendon injection of MMC | Active Comparator | intratendon injection of 0.1 cc MMC 0.01% at the beginning of the procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MMC | Drug | using 0.02 MMC soaked sponged under the conjunctiva for 1 to 3 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| IOP (intraocular pressure) | Goldmann applanation tonometry | until 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bleb morphology | scoring the bleb morphologic features according to Indian Grading System | until 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| mohammad pakravan | Contact | 009822591616 | labbafi@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recruiting | Tehran | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28100482 | Derived | Pakravan M, Esfandiari H, Yazdani S, Douzandeh A, Amouhashemi N, Yaseri M, Pakravan P. Mitomycin C-augmented trabeculectomy: subtenon injection versus soaked sponges: a randomised clinical trial. Br J Ophthalmol. 2017 Sep;101(9):1275-1280. doi: 10.1136/bjophthalmol-2016-309671. Epub 2017 Jan 18. |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| MMC | Drug | 0.1 cc of 0.01% MMC is injected into the tenon. |
|