STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Open Angle Glaucoma

Intervention / Treatment
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* Device: STARflo Implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| STARflo<br>Patients who have been implanted with STARflo implant | Device: STARflo Implant<br>* All patients who have been implanted with STARflo implant from 2011 will be offered to participate to this data collection<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma Drainage Device, STARflo