STARflo European Safety and Efficacy Study

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

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.

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