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

Alcon

Status: Completed

Conditions: Glaucoma

Treatments: Device: Ex-PRESS® Glaucoma Filtration Device, Model P50PL

Study type: Interventional

Funder types: Industry

Identifiers

NCT02246777

UMIN000013243 (Registry Identifier)

ALJ-P2013-1

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of normal tension glaucoma.
• Indicated for filtration surgery using Ex-PRESS®.
• Understand and provide Informed Consent.
• Other protocol-defined inclusion criteria may apply.

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.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Ex-PRESS

Experimental group

Description:

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

Treatment:

Device: Ex-PRESS® Glaucoma Filtration Device, Model P50PL