Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy (DUETTE)

Transcend Medical

Status: Completed

Conditions: Primary Open Angle Glaucoma (POAG)

Treatments: Device: CyPass Micro-Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT01166659

TMI-10-03

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of CyPass implantation as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy

Enrollment: 48 patients

Sex: All

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of POAG
• Medicated IOP ≥ 21 and ≤ 35 mmHg
• Use of 1 - 4 topical IOP lowering medications

Exclusion criteria

• Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
• Use of oral hypotensive medication treatment for glaucoma
• Previous incisional glaucoma surgery, or any combined cataract-glaucoma procedure
• Clinically significant ocular pathology other than POAG

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

CyPass Micro-Stent

Experimental group

Description:

Subjects receive the CyPass Micro-Stent

Treatment:

Device: CyPass Micro-Stent