NCT02448875

Clinical Evaluation of Visco-Assisted CyPass® Micro-Stent Implantation in Patients With Open Angle Glaucoma

Randomized, Prospective Clinical Evaluation of the Safety and Effectiveness of Visco-Assisted CyPass® Implantation in Patients With Open Angle Glaucoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Transcend Medical, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and effectiveness of the use of visco-assisted CyPass® Micro-Stent implantation for the lowering of intraocular pressure (IOP) in subjects who have open angle glaucoma (OAG).

Detailed description

The study was conducted in 2 phases. Only one eye per subject was treated for each independent phase. Dose Selection Phase (Cohort 1): Subjects were randomized in a 1:1:1 ratio and implanted with either a CyPass Micro-Stent with targeted delivery of 30 microliters (μl) ophthalmic 5 viscoelastic, a CyPass Micro-Stent with targeted delivery of 60 μl of ophthalmic viscoelastic, or a CyPass Micro-Stent without adjunct viscoelastic in the study eye. Expansion Phase (Cohort 2): Subjects were randomized in a 1:1 ratio and implanted with either the CyPass Micro-Stent without adjunct viscoelastic or the CyPass Micro-Stent with 60 μl of ophthalmic viscoelastic (based on Dose Selection results). Subjects were randomized to treatment on the day of their surgical procedure. A total of 9 scheduled visits were planned including Screening (Day -45 to -2), Baseline (Day -15 to -1), Surgery (Day 0), 1 Day (Day 1), 1 Week (Day 5-9), 1 Month (Day 21-35), 3 Month (Day 70-98), 6 Month (Day 150-210), and 12 Month (Day 330-420) visits. The total expected duration of participation for each subject was up to 13 months.

Conditions

• Open Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	CyPass Micro-Stent	Small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye in order to reduce intraocular pressure. Designed to be permanently implanted in the eye.
DEVICE	Viscoelastic	Healon 5 ophthalmic viscoelastic used to increase the size of the aqueous drainage area created by the CyPass Micro-Stent

Timeline

• Start date: 2013-06-21
• Primary completion: 2017-06-22
• Completion: 2017-06-22
• First posted: 2015-05-20
• Last updated: 2019-06-12
• Results posted: 2019-05-30

Locations

6 sites across 4 countries: Germany, Panama, Poland, Spain

Regulatory

• FDA-regulated device study