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

Primary Open Angle Glaucoma (POAG) Clinical Trial

— DUETTE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166659
• Other study ID #: TMI-10-03
• Status: Completed
• Phase: N/A
• First received: July 14, 2010
• Last updated: May 12, 2017
• Start date: February 2010
• Est. completion date: May 2014

Study information

• Verified date: October 2016
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma (POAG)

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Transcend Medical, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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