Trabeculectomy With MMC Versus Ahmed Glaucoma Implant for Treatment of Pediatric Aphakic Glaucoma

October 6, 2006 updated by: Shahid Beheshti University of Medical Sciences
In this randomized clinical trial we compare trabeculectomy with mitomycin-C (T+MMC) and Ahmed glaucoma implant (AGI) in treatment of aphakic glaucoma in children under 16 years of age.Complete and qualified success were defined as 5≤IOP≤21mmHg without and with medication respectively and we came to this point that; T+MMC and AGI are comparable in terms of success rate and complications in pediatric aphakic glaucoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • 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 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

1 second to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • congenital cataract
  • history of cataract surgery
  • under 16 years old
  • Ocular pressure more than 21 mmHg

Exclusion Criteria:

  • interruption of the follow up before 6 month
  • Anterior segment dysgenesis

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: Single

Collaborators and Investigators

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

Sponsor

Shahid Beheshti University of Medical Sciences

Investigators

  • Principal Investigator: Mohammad Pakravan, MD, Ophthalmic Research Center of Shaheed Beheshti Medical University

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

March 1, 2004

Study Completion

November 1, 2005

Study Registration Dates

First Submitted

August 31, 2006

First Submitted That Met QC Criteria

August 31, 2006

First Posted (Estimate)

September 1, 2006

Study Record Updates

Last Update Posted (Estimate)

October 9, 2006

Last Update Submitted That Met QC Criteria

October 6, 2006

Last Verified

July 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8370 (Duke legacy protocol 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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