Status:
COMPLETED
STARflo European Safety and Efficacy Study
Lead Sponsor:
iSTAR Medical
Conditions:
Open Angle Glaucoma
Eligibility:
All Genders
18+ years
Phase:
NA
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. Patie...
Eligibility Criteria
Inclusion
- Main
- Diagnosis of refractory open angle glaucoma
- Documented 21 mmHg \< IOP ≤ 40 mmHg, under medication
- Patient must provide written informed consent
- Main
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT02272569
Start Date
September 1 2014
End Date
July 1 2019
Last Update
February 15 2021
Active Locations (8)
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1
UZA
Edegem, Belgium, 2650
2
CHU Sart Tilman
Liège, Belgium
3
MHAT Central Onco Hospital
Plovdiv, Bulgaria
4
Hopital de la Croix-Rousse
Lyon, France, 69417