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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01166659
First Posted: July 21, 2010
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research ( Transcend Medical, Inc. )
  Purpose
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

Condition Intervention
Primary Open Angle Glaucoma (POAG) Device: CyPass Micro-Stent

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research ( Transcend Medical, Inc. ):

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 48
Study Start Date: February 2010
Study Completion Date: May 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CyPass Micro-Stent
Subjects receive the CyPass Micro-Stent
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166659


Sponsors and Collaborators
Transcend Medical, Inc.
Investigators
Study Chair: Vice President of Medical Affairs Transcend Medical, Inc.
  More Information

Responsible Party: Transcend Medical, Inc.
ClinicalTrials.gov Identifier: NCT01166659     History of Changes
Other Study ID Numbers: TMI-10-03
First Submitted: July 14, 2010
First Posted: July 21, 2010
Results First Submitted: August 25, 2016
Results First Posted: October 28, 2016
Last Update Posted: May 15, 2017
Last Verified: October 2016

Keywords provided by Alcon Research ( Transcend Medical, Inc. ):
Glaucoma
Glaucoma device
Glaucoma surgery
Intraocular pressure

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases