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

Phase 3

• Conditions: Glaucoma
• Interventions: Drug: MMC

• Registration Number: NCT02385370
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-12
• Study Start: 2014-12
• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-10
• Last Update Submitted: 2015-03-10
• Study First Posted: 2015-03-11
• Last Update Posted: 2015-03-11
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Advanced uncontrolled glaucoma patients.

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Exclusion Criteria

• History of any kind of intraocular surgery.
• Monocular patients.
• Unwillingness to participate in the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
using standard method of applying MMC	MMC	applying MMC 0.02 % soaked sponges under conjunctival space for 1 to 3 minutes
intratendon injection of MMC	MMC	intratendon injection of 0.1 cc MMC 0.01% at the beginning of the procedure

Primary Outcome Measures

Name	Time	Method
IOP (intraocular pressure)	until 6 months	Goldmann applanation tonometry

Secondary Outcome Measures

Name	Time	Method
Bleb morphology	until 6 months	scoring the bleb morphologic features according to Indian Grading System