Back to resultsStudy of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy (DUETTE)
Primary Purpose
Primary Open Angle Glaucoma (POAG)
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CyPass Micro-Stent
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open Angle Glaucoma (POAG) focused on measuring Glaucoma, Glaucoma device, Glaucoma surgery, Intraocular pressure
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CyPass Micro-Stent
Arm Description
Subjects receive the CyPass Micro-Stent
Outcomes
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01166659
Brief Title
Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy
Acronym
DUETTE
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Transcend Medical, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma (POAG)
Keywords
Glaucoma, Glaucoma device, Glaucoma surgery, Intraocular pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CyPass Micro-Stent
Arm Type
Experimental
Arm Description
Subjects receive the CyPass Micro-Stent
Intervention Type
Device
Intervention Name(s)
CyPass Micro-Stent
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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 Outcome Measure Information:
Title
Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication
Description
Target IOP was defined as ≥ 6 mmHg and ≤ 21 mmHg. Proportion of eyes is reported as a percentage.
Time Frame
Month 12 postoperative
Title
Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vice President of Medical Affairs
Organizational Affiliation
Transcend Medical, Inc.
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy
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