Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

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

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00371072

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

No publications provided 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:
Eye Diseases
Ocular Hypertension processed this record on March 02, 2015