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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2005-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pediatric Aphakic Glaucoma

Keywords

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Aphakic Glaucoma trabeculectomy with mitomycin- C Ahmed glaucoma implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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trabeculectomy with mitomycin-C

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

0 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Mohammad Pakravan, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Research Center of Shaheed Beheshti Medical University

Locations

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Ophthalmic Research Center

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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8370

Identifier Type: -

Identifier Source: org_study_id