Alcon® Ex-PRESS® Glaucoma Filtration Device in Japanese Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-26

Study Completion Date

2016-10-24

Brief Summary

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The purpose of this study is to assess the efficacy and safety of the Alcon Ex-PRESS® Glaucoma Filtration Device (Ex-PRESS) in Japanese subjects with normal tension glaucoma.

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Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ex-PRESS

Ex-PRESS® Glaucoma Filtration Device, Model P50PL, implanted in the anterior chamber of the study eye during glaucoma surgery intended for the lifetime of the patient

Group Type EXPERIMENTAL

Ex-PRESS® Glaucoma Filtration Device, Model P50PL

Intervention Type DEVICE

Interventions

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Ex-PRESS® Glaucoma Filtration Device, Model P50PL

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of normal tension glaucoma.
* Indicated for filtration surgery using Ex-PRESS®.
* Understand and provide Informed Consent.

Exclusion Criteria

* Women who are pregnant, lactating, or planning to be pregnant during the study period.
* Diagnosis of angle closure glaucoma or secondary glaucoma.
* History of glaucoma surgery.
* Ophthalmologic surgery within the past 6 months.
* Difficulty with applanation tonometry measurement.
* Corneal dystrophy.
* Infectious/non-infectious conjunctivitis, keratitis, or uveitis in either eye.
* Severe blepharitis or dry eye.
* History of metal allergy.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No