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

Primary Purpose

Pediatric Aphakic Glaucoma

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
trabeculectomy with mitomycin-C
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Aphakic Glaucoma focused on measuring Aphakic Glaucoma, trabeculectomy with mitomycin- C, Ahmed glaucoma implant

Eligibility Criteria

0 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ophthalmic Research Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 31, 2006
Last Updated
October 6, 2006
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00371072
Brief Title
Trabeculectomy With MMC Versus Ahmed Glaucoma Implant for Treatment of Pediatric Aphakic Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2003
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Aphakic Glaucoma
Keywords
Aphakic Glaucoma, trabeculectomy with mitomycin- C, Ahmed glaucoma implant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
trabeculectomy with mitomycin-C

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Pakravan, MD
Organizational Affiliation
Ophthalmic Research Center of Shaheed Beheshti Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
ZIP/Postal Code
16666
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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