STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program

Open Angle Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02825264
• Other study ID #: ISM03
• Status: Active, not recruiting
• Start date: July 2016
• Est. completion date: December 2026

Study information

• Verified date: August 2022
• Source: iSTAR Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients suffering from open angle glaucoma or some case of narrow angle glaucoma who have been implanted with STARflo implant from 2011
• Patients who have signed a Data Release form

Exclusion criteria:

• Patients who did not sign a Data Release form

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open Angle Glaucoma

Intervention

Device:
• STARflo Implant
All patients who have been implanted with STARflo implant from 2011 will be offered to participate to this data collection

Locations

Country	Name	City	State
Belgium	Bât. BC-3 OPHTALMOLOGIE - POLICLINIQUE C.H.U.	Liège
France	Hospital de la Croix-Rousse	Lyon
France	CHNO des Quinze-Vingts	Paris
Germany	St. Johannes Hospital Dortmund	Dortmund
Germany	Universitäts-Augenklinik Heidelberg	Heidelberg
Germany	Klinikum der Universität München	München
Germany	Augenklinik Universitätsmedizin Rostock	Rostock
Hungary	Elisabeth Academic Hospital	Sopron
Spain	Hospital Ramon y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
iSTAR Medical

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Hungary,  Spain, 

Outcome

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