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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00371072
Other study ID # 8370
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received August 31, 2006
Last updated October 6, 2006
Start date March 2004
Est. completion date November 2005

Study information

Verified date July 2003
Source hahid Beheshti University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date November 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 16 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

Procedure:
trabeculectomy with mitomycin-C


Locations

Country Name City State
Iran, Islamic Republic of Ophthalmic Research Center Tehran

Sponsors (1)

Lead Sponsor Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of,