drugset / Trial / NCT02385370

Bleb Function and Morphology With Intratendon Injection of MMC Compared With Standard Method

NCT02385370

Phase 3 Unknown 126 enrolled Shahid Beheshti University of Medical Sciences
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2014-12
Primary completion
2015-12
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mitomycin C Other / unclassified 0.01 % Other
Comparator Mitomycin C Other / unclassified 0.02 % Other

Indications