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

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

Study Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma (POAG)
• Intervention / Treatment: Device: CyPass Micro-Stent

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CyPass Micro-Stent; Subjects receive the CyPass Micro-Stent	Device: CyPass Micro-Stent; The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye. The CyPass is implanted in the eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% at 12 Months Postoperatively Who Were on Fewer or the Same Number of Ocular Hypotensive Medications as Compared With Baseline	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. Proportion of eyes is reported as a percentage.	Baseline; Month 12 postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication	Target IOP was defined as ≥ 6 mmHg and ≤ 21 mmHg. Proportion of eyes is reported as a percentage.	Month 12 postoperative
Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline	The number of unique glaucoma medications was recorded. The mean number of topical IOP-lowering medications was computed by dividing the total number of medications used (the numerator) by the total number of subjects who reported on medication use at the visit.	Baseline, Month 12 postoperative

Collaborators and Investigators

• Sponsor: Transcend Medical, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ACTUAL): May 1, 2013
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: July 14, 2010
• First Submitted That Met QC Criteria: July 19, 2010
• First Posted (ESTIMATE): July 21, 2010

Study Record Updates

• Last Update Posted (ACTUAL): May 15, 2017
• Last Update Submitted That Met QC Criteria: May 12, 2017
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Intraocular pressure; Glaucoma; Glaucoma device; Glaucoma surgery
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: TMI-10-03