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

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00371072
First received: August 31, 2006
Last updated: October 6, 2006
Last verified: July 2003
  Purpose

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.


Condition Intervention Phase
Pediatric Aphakic Glaucoma
Procedure: trabeculectomy with mitomycin-C
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

Study Start Date: March 2004
Estimated Study Completion Date: November 2005
  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00371072

Locations
Iran, Islamic Republic of
Ophthalmic Research Center
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti Medical University
Investigators
Principal Investigator: Mohammad Pakravan, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00371072     History of Changes
Other Study ID Numbers: 8370
Study First Received: August 31, 2006
Last Updated: October 6, 2006
Health Authority: Iran: Ethics Committee

Keywords provided by Shahid Beheshti Medical University:
Aphakic Glaucoma
trabeculectomy with mitomycin- C
Ahmed glaucoma implant

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents

ClinicalTrials.gov processed this record on April 15, 2014