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

NCT02385370 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2015-03-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

MMC

using 0.02 MMC soaked sponged under the conjunctiva for 1 to 3 minutes

DRUG

MMC

0.1 cc of 0.01% MMC is injected into the tenon.

Sponsors & Collaborators

  • Shahid Beheshti University of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-12-31

Countries

  • Iran

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02385370 on ClinicalTrials.gov