Glaucoma
Conditions
Brief summary
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.
Interventions
DRUGMMC
using 0.02 MMC soaked sponged under the conjunctiva for 1 to 3 minutes
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Advanced uncontrolled glaucoma patients.
Exclusion criteria
* History of any kind of intraocular surgery. * Monocular patients. * Unwillingness to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOP (intraocular pressure) | until 6 months | Goldmann applanation tonometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleb morphology | until 6 months | scoring the bleb morphologic features according to Indian Grading System |
Countries
Iran
Contacts
Primary Contactmohammad pakravan
Outcome results
None listed