Ahmed Glaucoma Valve and Single-Plate Molteno Implants in Treatment of Refractory Glaucoma

NCT ID: NCT00971061

Last Updated: 2009-09-04

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

PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2005-08-31

Brief Summary

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The purpose of this study is to investigate the efficacy and safety of the Ahmed valve implant (AVI) and the Molteno single-plate implant (MSPI) in eyes with refractory glaucoma during a follow-up period of 24 months.

Detailed Description

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Conditions

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Refractory Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MSPI

Molteno single-plate implant

Group Type EXPERIMENTAL

Molteno single-plate implant (MSPI)

Intervention Type DEVICE

134 mm2 surface area single-plate Molteno implant (Molteno Ophthalmic Limited, Dunedin, New Zealand)

AVI

Ahmed valve implant

Group Type ACTIVE_COMPARATOR

Ahmed valve implant

Intervention Type DEVICE

184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA)

Interventions

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Ahmed valve implant

184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA)

Intervention Type DEVICE

Molteno single-plate implant (MSPI)

134 mm2 surface area single-plate Molteno implant (Molteno Ophthalmic Limited, Dunedin, New Zealand)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* refractory glaucoma, defined as uncontrolled IOP despite maximal anti-glaucoma medication, previously failed nonseton surgical treatment, or a combination thereof.

Exclusion Criteria

* age less than 40 years
* a visual acuity of no light perception
* lens opacity
* elevated IOP associated with silicone oil previous glaucoma drainage device implantation in the same eye
* previous cyclodestructive treatment
* increased risk of endophthalmitis posterior segment disorders
* pre-existing ocular comorbidities.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanak Eye Surgery Center

OTHER

Sponsor Role lead

Principal Investigators

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Nader Nassiri, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor, Department of Ophthalmology, Imam Hussein Medical Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran

Nariman Nassiri, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Researcher, Vanak Eye Surgery Center, Tehran, Iran

Ghazal Kamali, MD

Role: PRINCIPAL_INVESTIGATOR

4th-year Resident, Department of Ophthalmology, Imam Hussein Medical Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran

Locations

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Vanak Eye Surgery Center

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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1465087

Identifier Type: -

Identifier Source: org_study_id

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