STARflo European Safety and Efficacy Study
- Conditions
- Open Angle Glaucoma
- Registration Number
- NCT02272569
- Lead Sponsor
- iSTAR Medical
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- Diagnosis of refractory open angle glaucoma
- Documented 21 mmHg < IOP ≤ 40 mmHg, under medication
- Patient must provide written informed consent
Main
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Reduction in mean diurnal intraocular pressure (IOP) at 12 months vs. baseline IOP 12 months IOP of each patients at baseline will be compared to IOP of patient after 12 months
- Secondary Outcome Measures
Name Time Method Reduction in mean diurnal intraocular pressure (IOP) at 24 months vs. baseline IOP 24 months IOP of each patients at baseline will be compared to IOP of patient after 24 months
Reduction in number of IOP lowering medications at 12 months vs. baseline 12 months compare number of active ingredient of each patients at baseline vs number of active ingredient after 12 months
Reduction in number of IOP lowering medications at 24 months vs. baseline 24 months compare number of active ingredient of each patients at baseline vs number of active ingredient after 24 months
Rate of adverse events 24 months assessment and counting of adverse events (% by adverse event) including procedure related complications
Visual Acuity 12 months comparison of visual acuity at 12 months vs. baseline
Absolute success rate (%) at 12 months 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
Qualified success rate (%) at 12 months 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
Qualified success rate (%) at 24 months 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
Absolute success rate (%) at 24 months 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
Trial Locations
- Locations (8)
UZA
🇧🇪Edegem, Belgium
CHU Sart Tilman
🇧🇪Liège, Belgium
MHAT Central Onco Hospital
🇧🇬Plovdiv, Bulgaria
Hopital de la Croix-Rousse
🇫🇷Lyon, France
CHNO des Quinze Vingts
🇫🇷Paris, France
University Clinic Heidelberg
🇩🇪Heidelberg, Germany
Ludwig-Maximilians-University Munich
🇩🇪Munich, Germany
Universitatsklinik fur Augenheilkunde Inselspital
🇨🇭Bern, Switzerland
UZA🇧🇪Edegem, Belgium