NCT02825264

STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program

STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program in a Real-World Patient Population

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: iSTAR Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

STARflo is a novel suprachoroidal Glaucoma Drainage Device (GDD), bleb-free, exhibiting anti-fibrotic properties. Release of this CE Marked implant has been limited to leading Glaucoma Centers in Europe.

Detailed description

This Clinical Experience Program is being initiated to expand the surgical and clinical practice knowledge about the use of STARflo for reducing intraocular pression (IOP) in patients suffering from open angle glaucoma in a real world population of patients. This program is designed to be an international multicenter observational study. Patient data may be collected retrospectively and/or prospectively for up to 5 years after surgery. The aim of this program is to document the patient's benefit following implantation of the STARflo implant in a real-word patient population, to learn about surgical practices and to collect data to support future cost-effectiveness analysis.

Conditions

• Open Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	STARflo Implant	All patients who have been implanted with STARflo implant from 2011 will be offered to participate to this data collection

Timeline

• Start date: 2016-07-01
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2016-07-07
• Last updated: 2022-08-09

Locations

9 sites across 5 countries: Belgium, France, Germany, Hungary, Spain