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

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
MMC
MMC
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

using standard method of applying MMC

intratendon injection of MMC

Arm Description

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

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

Outcomes

Primary Outcome Measures

IOP (intraocular pressure)
Goldmann applanation tonometry

Secondary Outcome Measures

Bleb morphology
scoring the bleb morphologic features according to Indian Grading System

Full Information

First Posted
March 4, 2015
Last Updated
March 10, 2015
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02385370
Brief Title
Bleb Function and Morphology With Intratendon Injection of MMC Compared With Standard Method
Acronym
conj mmc
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
using standard method of applying MMC
Arm Type
Active Comparator
Arm Description
applying MMC 0.02 % soaked sponges under conjunctival space for 1 to 3 minutes
Arm Title
intratendon injection of MMC
Arm Type
Active Comparator
Arm Description
intratendon injection of 0.1 cc MMC 0.01% at the beginning of the procedure
Intervention Type
Drug
Intervention Name(s)
MMC
Intervention Description
using 0.02 MMC soaked sponged under the conjunctiva for 1 to 3 minutes
Intervention Type
Drug
Intervention Name(s)
MMC
Intervention Description
0.1 cc of 0.01% MMC is injected into the tenon.
Primary Outcome Measure Information:
Title
IOP (intraocular pressure)
Description
Goldmann applanation tonometry
Time Frame
until 6 months
Secondary Outcome Measure Information:
Title
Bleb morphology
Description
scoring the bleb morphologic features according to Indian Grading System
Time Frame
until 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Advanced uncontrolled glaucoma patients. Exclusion Criteria: History of any kind of intraocular surgery. Monocular patients. Unwillingness to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohammad pakravan
Phone
009822591616
Email
labbafi@hotmail.com
Facility Information:
City
Tahran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohammad pakravan
Phone
009822591616
Email
labbafi@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
28100482
Citation
Pakravan M, Esfandiari H, Yazdani S, Douzandeh A, Amouhashemi N, Yaseri M, Pakravan P. Mitomycin C-augmented trabeculectomy: subtenon injection versus soaked sponges: a randomised clinical trial. Br J Ophthalmol. 2017 Sep;101(9):1275-1280. doi: 10.1136/bjophthalmol-2016-309671. Epub 2017 Jan 18.
Results Reference
derived

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

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