STARflo European Safety and Efficacy Study

iSTAR Medical42 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Open Angle Glaucoma

Interventions

STARflo Glaucoma ImplantDEVICE

Implantation of the STARflo Glaucoma Implant following surgical technique described in European labelling. Procedure does not require the use of anti-fibrotic medications.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

UZA

Edegem, Belgium

CHU Sart Tilman

Liège, Belgium

MHAT Central Onco Hospital

Plovdiv, Bulgaria

Hopital de la Croix-Rousse

Lyon, France

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 24 months

Rate of adverse events

assessment and counting of adverse events (% by adverse event) including procedure related complications

Time frame: 24 months

Visual Acuity

comparison of visual acuity at 12 months vs. baseline

Time frame: 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

Time frame: 12 months

Data from ClinicalTrials.gov

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