STARflo European Safety and Efficacy Study

Study Overview
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Brief Summary
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Prospective, Non-comparative, Multi-center clinical trial to evaluate the safety and efficacy of the STARflo Glaucoma Implant in patients with refractory open angle glaucoma.

Detailed Description
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This is a prospective, multicenter clinical trial to assess the efficacy and the safety of the STARflo™ Glaucoma Implant. Patients will enter the study after providing written informed consent. Patients will be screened to confirm that they are eligible for study participation. When eligibility has been established using the in/exclusion criteria, surgery will be scheduled. Pre and post-surgery, patients will be evaluated at scheduled intervals (1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 24 months) for a total duration of 24 months following surgery.

Official Title
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A Prospective, Non-comparative, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of the STARflo Glaucoma Implant in Patients With Open Angle Glaucoma

Conditions
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Open Angle Glaucoma

Intervention / Treatment
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* Device: STARflo Glaucoma Implant


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Diagnosis of refractory open angle glaucoma Documented 21 mmHg < IOP ≤ 40 mmHg, under medication Patient must provide written informed consent Main Exclusion Criteria: Patients with diagnosis of glaucoma other than open angle glaucoma (e.g. angle closure glaucoma) in the study eye Patients who failed one or more cilio ablative procedure in the study eye if these cilio ablative procedures were performed as a consequence of previous failed filtering surgery Clinically significant intra-ocular inflammation or infection, presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis, active proliferative/inflammatory retinopathy in the study eye

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STARflo Glaucoma Implant<br>Implantation of the STARflo Glaucoma Implant by an ab-externa technique with connection from the anterior chamber to the suprachoroidal space | Device: STARflo Glaucoma Implant<br>* Implantation of the STARflo Glaucoma Implant following surgical technique described in European labelling. Procedure does not require the use of anti-fibrotic medications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in mean diurnal intraocular pressure (IOP) at 12 months vs. baseline IOP | IOP of each patients at baseline will be compared to IOP of patient after 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in mean diurnal intraocular pressure (IOP) at 24 months vs. baseline IOP | IOP of each patients at baseline will be compared to IOP of patient after 24 months | 24 months | 
| Reduction in number of IOP lowering medications at 12 months vs. baseline | compare number of active ingredient of each patients at baseline vs number of active ingredient after 12 months | 12 months | 
| Reduction in number of IOP lowering medications at 24 months vs. baseline | compare number of active ingredient of each patients at baseline vs number of active ingredient after 24 months | 24 months | 
| Rate of adverse events | assessment and counting of adverse events (% by adverse event) including procedure related complications | 24 months | 
| Visual Acuity | comparison of visual acuity at 12 months vs. baseline | 12 months | 
| Absolute success rate (%) at 12 months | absolute success: IOP < 21mmHg and < 5mmHg with a minimum of 30% IOP reduction compared to baseline without the need for concomitant glaucoma medication | 12 months | 
| Qualified success rate (%) at 12 months | qualified success: IOP < 21mmHg and < 5mmHg with a minimum of 30% IOP reduction compared to baseline with and without the need for concomitant glaucoma medication | 12 months | 
| Qualified success rate (%) at 24 months | qualified success: IOP < 21mmHg and < 5mmHg with a minimum of 30% IOP reduction compared to baseline with and without the need for concomitant glaucoma medication | 24 months | 
| Absolute success rate (%) at 24 months | absolute success: IOP < 21mmHg and < 5mmHg with a minimum of 30% IOP reduction compared to baseline without the need for concomitant glaucoma medication | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, glaucoma drainage device, glaucoma shunt