Bleb Function and Morphology With Intratendon Injection of MMC Compared With Standard Method (conj mmc)

Shahid Beheshti University of Medical Sciences

Status and phase: Unknown; Phase 3

Conditions: Glaucoma

Treatments: Drug: MMC

Study type: Interventional

Funder types: Other

Identifiers

NCT02385370

92181

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced uncontrolled glaucoma patients.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

using standard method of applying MMC

Active Comparator group

Description:

applying MMC 0.02 % soaked sponges under conjunctival space for 1 to 3 minutes

Treatment:

Drug: MMC

Drug: MMC

intratendon injection of MMC

Active Comparator group

Description:

intratendon injection of 0.1 cc MMC 0.01% at the beginning of the procedure

Treatment:

Drug: MMC

Drug: MMC