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

NCT01166659 | Completed Results

• 1 other identifier: TMI-10-03
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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

Conditions

Primary Open Angle Glaucoma (POAG)

Keywords

Glaucoma; Glaucoma device; Glaucoma surgery; Intraocular pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Month 12 postoperative

• Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline

  Baseline, Month 12 postoperative

Study Arms (1)

CyPass Micro-Stent

EXPERIMENTAL

Subjects receive the CyPass Micro-Stent

Device: CyPass Micro-Stent

Interventions

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.

CyPass Micro-Stent

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of POAG
• Medicated IOP ≥ 21 and ≤ 35 mmHg
• Use of 1 - 4 topical IOP lowering medications

You may not qualify if:

• 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

Sponsors & Collaborators

• Transcend Medical, Inc.: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Vice President of Medical Affairs
• Organization: Transcend Medical, Inc.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Vice President of Medical Affairs

  Transcend Medical, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 21, 2010
• Study Start: February 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2014
• Last Updated: May 15, 2017
• Results First Posted: October 28, 2016

Record last verified: 2016-10