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

March 10, 2015 updated by: Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences

Bleb Function and Morphology With Intratendon Injection of 0.1 mg MMC in Comparison With Conventional Subtenon Application of 0.02% MMC Soaked Sponges in Trabeculectomy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

126

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Advanced uncontrolled glaucoma patients.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: using standard method of applying MMC
applying MMC 0.02 % soaked sponges under conjunctival space for 1 to 3 minutes
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.
Active Comparator: intratendon injection of MMC
intratendon injection of 0.1 cc MMC 0.01% at the beginning of the procedure
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOP (intraocular pressure)
Time Frame: until 6 months
Goldmann applanation tonometry
until 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleb morphology
Time Frame: until 6 months
scoring the bleb morphologic features according to Indian Grading System
until 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

March 4, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Estimate)

March 11, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 92181

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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