STARflo European Safety and Efficacy Study

iSTAR Medical

Status

Completed

Conditions

Open Angle Glaucoma

Treatments

Device: STARflo Glaucoma Implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT02272569

ISM01

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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