Comparison of Two Method Antimetabolites Application on Corneal Function in Trabeculectomy Surgery

February 16, 2011 updated by: Shahid Beheshti University of Medical Sciences

Corneal Endothelial Cell Loss Following Trabeculectomy With mitomycin_c Application Before Versus After Sclera Flap Dissection

Application of antimetabolite agents such as mitomycin_c has improved trabeculectomy results and better control of intraocular pressure complications such as corneal endothelial cell loss. However, Mitomycin_c can be applied remain a concern before or after sclera flap dissection. Mitomycin_c application after sclera flap dissection probably increases corneal endothelial cell loss. This study compares Mitomycin_c application two methods: before and after sclera flap dissection with regard to success rate and complication. patients on base of Mitomycin_c application time (1-2-3) minutes will be match randomise in to two groups( before and after sclera flap dissection) corneal. Endothelial cell density, polymorphism, polymegathism and intraocular pressure before and one month, three months, six months after surgery will measured.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

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

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

15 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age Range between 18 to 80 years old
  • Trabeculectomy to JOAC, POAG, CACG, PXF, pigment dispersion syndrome.

Exclusion Criteria:

  • Secondary glaucoma (active uveitis, NVG, specific syndromes such as axenfeld rieger, Iridocorneal Endothelial syndrome, aniridia, peters, etc).

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Mitomycin_c application before sclera flap dissection
Drug: Mitomycin_c
0.02%.1,2,3,minutes match randomized in to two groups(before &after scleral flap dissection
ACTIVE_COMPARATOR: Mitomycin_c application after sclera flapdissection
Drug: Mitomycin_c
0.02%.1,2,3,minutes match randomized in to two groups(before &after scleral flap dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
corneal endothelial cell density
Time Frame: six month
specular microscopy
six month
corneal endothelial cell polymorphism
Time Frame: 6 months
specular microscopy
6 months
corneal endothelial cell polymegathism
Time Frame: 6 months
specular microscopy
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOP (intra ocular pressure)
Time Frame: six months
applanation tonometry
six months

Collaborators and Investigators

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

Sponsor

Shahid Beheshti University of Medical Sciences

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

November 1, 2010

Primary Completion (ANTICIPATED)

June 1, 2011

Study Completion (ANTICIPATED)

December 1, 2011

Study Registration Dates

First Submitted

January 19, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (ESTIMATE)

February 17, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 17, 2011

Last Update Submitted That Met QC Criteria

February 16, 2011

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8772 (Other Identifier: FHCRC IRB Number)

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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