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

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

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Key information

Conditions

Primary Open Angle Glaucoma (POAG) Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CyPass Micro-Stent

Device

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.

Primary outcomes

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

Time frame: Baseline; Month 12 postoperative

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.

Secondary outcomes

Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication

Time frame: Month 12 postoperative

Target IOP was defined as ≥ 6 mmHg and ≤ 21 mmHg. Proportion of eyes is reported as a percentage.
Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline

Time frame: Baseline, Month 12 postoperative

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.

Sponsors and collaborators

Lead sponsor

Transcend Medical, Inc.

Industry

Registry information

Acronym: DUETTE

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2014
First posted: Jul 21, 2010
Registry last updated: May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed