Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy (DUETTE)
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|ClinicalTrials.gov Identifier: NCT01166659|
Recruitment Status : Completed
First Posted : July 21, 2010
Results First Posted : October 28, 2016
Last Update Posted : May 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Primary Open Angle Glaucoma (POAG)||Device: CyPass Micro-Stent||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2014|
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.
- 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.
- 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.
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
|Study Chair:||Vice President of Medical Affairs||Transcend Medical, Inc.|