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

Transcend Medical, Inc.48 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Open Angle Glaucoma (POAG)

Interventions

CyPass Micro-StentDEVICE

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Outcomes

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

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.

Time frame: Baseline; Month 12 postoperative

Secondary Outcomes

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.

Time frame: 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.

Time frame: Baseline, Month 12 postoperative

Data from ClinicalTrials.gov

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