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

Not Applicable

Completed

• Conditions: Primary Open Angle Glaucoma (POAG)
• Interventions: Device: CyPass Micro-Stent

• Registration Number: NCT01166659
• Lead Sponsor: Transcend Medical, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-07-14
• Study First Submitted QC: 2010-07-19
• Study First Posted: 2010-07-21
• Primary Completion: 2013-05
• Study Completion: 2014-05
• Results First Submitted: 2016-08-25
• Results First Submitted QC: 2016-09-08
• Status Verified: 2016-10
• Results First Posted: 2016-10-28
• Last Update Submitted: 2017-05-12
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CyPass Micro-Stent	CyPass Micro-Stent	Subjects receive the CyPass Micro-Stent

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication	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	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.