NCT01640756

AqueSys Microfistula Implant in Refractory Glaucoma

A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys Microfistula Implant in Subjects With Refractory Glaucoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: AqueSys, Inc. · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

To establish the safety and performance of the AqueSys Microfistula Implant in eyes with refractory glaucoma.

Detailed description

A prospective, multi-center, single arm, open-label clinical trial to evaluate the safety and IOP lowering performance of the AqueSys Microfistula Implant in refractory glaucoma patients who have previously failed a glaucoma procedure and who are not well-controlled on IOP lowering medications.

Conditions

• Glaucoma
• Glaucoma, Open-Angle

Interventions

Type	Name	Description
DEVICE	AqueSys Microfistula Implant	Placement of the AqueSys Microfistula Implant in the study eye

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-11-01
• Completion: 2015-04-01
• First posted: 2012-07-16
• Last updated: 2016-02-08

Locations

14 sites across 1 country: United States