Results of Different Location of Ahmed Glaucoma Valve Implantation in Refractory Glaucoma, Superior Versus Inferior

NCT ID: NCT00628173

Last Updated: 2008-10-17

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

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-12-31

Brief Summary

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Purpose:To compare the efficacy and safety of Ahmed Glaucoma Valve (AGV) implantation in the superior versus inferior quadrants.

Methods: In a non-randomized clinical trial and over a period of two years, consecutive patients with refractory glaucoma underwent AGV implantation in the superior or inferior quadrants. Main outcome measures included best corrected visual acuity (BCVA), intraocular pressure (IOP), number of glaucoma medications, complications and success rate (defined as at least 30% IOP reduction below preoperative values and 5\<IOP\<22 mmHg with or without glaucoma medications). Other criteria for failure included implant removal, additional glaucoma surgery, phthisis bulbi or loss of light perception.

Detailed Description

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Conditions

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Glaucoma

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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1

patients with refractory glaucoma who were candidate for AGV implantation allocated in superior site

Group Type EXPERIMENTAL

AGV implantation

Intervention Type PROCEDURE

2

patients with refractory glaucoma who were candidate for AGV implantation allocated in inferior site

Group Type EXPERIMENTAL

AGV implantation

Intervention Type PROCEDURE

Interventions

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AGV implantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with refractory glaucoma who need AGV implantation

Exclusion Criteria

* Eyes with less than 3 months follow-up
* Severe conjunctival adhesions and scarring for the site of surgery
* Presence of thin sclera and staphyloma for the site of surgery
* The presence or anticipated need for silicone oil for superior implantation
* Active neovascular glaucoma for inferior implantation
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Other Identifiers

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8417

Identifier Type: -

Identifier Source: org_study_id