STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Open Angle Glaucoma
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Bât. BC-3 OPHTALMOLOGIE - POLICLINIQUE C.H.U.
• France
  • Lyon, France, 69317
    • Hospital de la Croix-Rousse
  • Paris, France, 75571
    • CHNO des Quinze-Vingts
• Germany
  • Dortmund, Germany, 44137
    • St. Johannes Hospital Dortmund
  • Heidelberg, Germany, 69120
    • Universitäts-Augenklinik Heidelberg
  • München, Germany, 81377
    • Klinikum der Universitat Munchen
  • Rostock, Germany, 18057
    • Augenklinik Universitätsmedizin Rostock
• Hungary
  • Sopron, Hungary, 9400
    • Elisabeth Academic Hospital
• Spain
  • Madrid, Spain
    • Hospital Ramon y Cajal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from open angle glaucoma or some case of narrow angle glaucoma who have been implanted with STARflo.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of intraocular pressure (IOP)	IOP reduction compared after 12 months compared to baseline IOP	at 12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Reduction of IOP lowering medication	Reduction of IOP lowering medication intake compare to baseline	at 6, 12, 24, 36, 48 and 60 Months

Collaborators and Investigators

• Sponsor: iSTAR Medical
• Investigators: Study Director: Zubair Hussain, PhD, Sponsor Representative

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (Estimate): July 7, 2016

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Glaucoma Drainage Device; STARflo
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: ISM03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No