STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program

N/AActive Not RecruitingNCT02825264

iSTAR Medical70 enrolled

Overview

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.

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

Conditions

Open Angle Glaucoma

Interventions

STARflo ImplantDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Reduction of intraocular pressure (IOP)

IOP reduction compared after 12 months compared to baseline IOP

Time frame: at 12 Months

Secondary Outcomes

Occurence of Ocular Adverse Events

to record and document all complications and Adverse Events/Adverse Device Effects occurred during and after surgery

Time frame: 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

Time frame: at 6, 24, 36, 48 and 60 Months

Reduction of IOP lowering medication

Reduction of IOP lowering medication intake compare to baseline

Time frame: at 6, 12, 24, 36, 48 and 60 Months

Data from ClinicalTrials.gov

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