STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program

Sponsor

iSTAR Medical (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02825264

Collaborator

(none)

Enrollment

Locations

125

Anticipated Duration (Months)

7.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Open Angle Glaucoma	Device: STARflo Implant

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 Design

Study Type:

Observational

Actual Enrollment :

70 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Jul 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
STARflo Patients who have been implanted with STARflo implant	Device: STARflo Implant All patients who have been implanted with STARflo implant from 2011 will be offered to participate to this data collection

Arm

Intervention/Treatment

STARflo

Patients who have been implanted with STARflo implant

Device: STARflo Implant

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

Outcome Measures

Primary Outcome Measures

Reduction of intraocular pressure (IOP) [at 12 Months]
IOP reduction compared after 12 months compared to baseline IOP

Secondary Outcome Measures

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 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
Reduction of IOP lowering medication [at 6, 12, 24, 36, 48 and 60 Months]
Reduction of IOP lowering medication intake compare to baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Bât. BC-3 OPHTALMOLOGIE - POLICLINIQUE C.H.U.	Liège	Belgium	4000
2	Hospital de la Croix-Rousse	Lyon	France	69317
3	CHNO des Quinze-Vingts	Paris	France	75571
4	St. Johannes Hospital Dortmund	Dortmund	Germany	44137
5	Universitäts-Augenklinik Heidelberg	Heidelberg	Germany	69120
6	Klinikum der Universität München	München	Germany	81377
7	Augenklinik Universitätsmedizin Rostock	Rostock	Germany	18057
8	Elisabeth Academic Hospital	Sopron	Hungary	9400
9	Hospital Ramon y Cajal	Madrid	Spain

Sponsors and Collaborators

iSTAR Medical

Investigators

Study Director: Zubair Hussain, PhD, Sponsor Representative

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

iSTAR Medical

ClinicalTrials.gov Identifier:

NCT02825264

Other Study ID Numbers:

ISM03

First Posted:

Jul 7, 2016

Last Update Posted:

Aug 9, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by iSTAR Medical

Glaucoma Drainage Device

STARflo

Additional relevant MeSH terms:

Glaucoma

Glaucoma, Open-Angle

Study Results

No Results Posted as of Aug 9, 2022