Open Angle Glaucoma
Conditions
Keywords
Glaucoma Drainage Device, STARflo
Brief summary
STARflo is a novel suprachoroidal Glaucoma Drainage Device (GDD), bleb-free, exhibiting anti-fibrotic properties. Release of this CE Marked implant has been limited to leading Glaucoma Centers in Europe.
Detailed description
This Clinical Experience Program is being initiated to expand the surgical and clinical practice knowledge about the use of STARflo for reducing intraocular pression (IOP) in patients suffering from open angle glaucoma in a real world population of patients. This program is designed to be an international multicenter observational study. Patient data may be collected retrospectively and/or prospectively for up to 5 years after surgery. The aim of this program is to document the patient's benefit following implantation of the STARflo implant in a real-word patient population, to learn about surgical practices and to collect data to support future cost-effectiveness analysis.
Interventions
DEVICESTARflo Implant
All patients who have been implanted with STARflo implant from 2011 will be offered to participate to this data collection
Sponsors
iSTAR Medical
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients suffering from open angle glaucoma or some case of narrow angle glaucoma who have been implanted with STARflo implant from 2011 * Patients who have signed a Data Release form
Exclusion criteria
* Patients who did not sign a Data Release form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of intraocular pressure (IOP) | at 12 Months | IOP reduction compared after 12 months compared to baseline IOP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurence of Ocular Adverse Events | up to 60 Months after surgery | to record and document all complications and Adverse Events/Adverse Device Effects occurred during and after surgery |
| Reduction of intraocular pressure (IOP) over time | at 6, 24, 36, 48 and 60 Months | IOP reduction compared after 6, 24, 36, 48 and 60 months compared to baseline IOP |
| Reduction of IOP lowering medication | at 6, 12, 24, 36, 48 and 60 Months | Reduction of IOP lowering medication intake compare to baseline |
Countries
Belgium, France, Germany, Hungary, Spain
Outcome results
None listed