STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program

Active, not recruiting

• Conditions: Open Angle Glaucoma

• Registration Number: NCT02825264
• Lead Sponsor: iSTAR Medical

Brief 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.

Study Timeline

• Study First Submitted: 2016-06-20
• Study Start: 2016-07
• Study First Submitted QC: 2016-07-06
• Study First Posted: 2016-07-07
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-09
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of intraocular pressure (IOP)	at 12 Months	IOP reduction compared after 12 months compared to baseline IOP

Secondary Outcome Measures

Name	Time	Method
Occurence of Ocular Adverse Events	up to 60 Months after surgery	to record and document all complications and Adverse Events/Adverse Device Effects occurred during and after surgery
Reduction of IOP lowering medication	at 6, 12, 24, 36, 48 and 60 Months	Reduction of IOP lowering medication intake compare to baseline
Reduction of intraocular pressure (IOP) over time	at 6, 24, 36, 48 and 60 Months	IOP reduction compared after 6, 24, 36, 48 and 60 months compared to baseline IOP

Trial Locations

Locations (9)

Bât. BC-3 OPHTALMOLOGIE - POLICLINIQUE C.H.U.; 🇧🇪 Liège, Belgium

Hospital de la Croix-Rousse; 🇫🇷 Lyon, France

CHNO des Quinze-Vingts; 🇫🇷 Paris, France

St. Johannes Hospital Dortmund; 🇩🇪 Dortmund, Germany

Universitäts-Augenklinik Heidelberg; 🇩🇪 Heidelberg, Germany

Klinikum der Universität München; 🇩🇪 München, Germany

Augenklinik Universitätsmedizin Rostock; 🇩🇪 Rostock, Germany

Elisabeth Academic Hospital; 🇭🇺 Sopron, Hungary

Hospital Ramon y Cajal; 🇪🇸 Madrid, Spain