Belkin-PMCF_v1.0
Research type
Research Study
Full title
An observational, registry-based study of performance and safety data from participants treated for open angle glaucoma or ocular hypertension with the Eagle® device.
IRAS ID
337141
Contact name
Gus Gazzard
Contact email
Sponsor organisation
Belkin Vision Ltd
Duration of Study in the UK
1 years, 0 months, 3 days
Research summary
The aim of the registry is to assess performance and safety of the Eagle device on people treated for Open Angle Glaucoma and Ocular Hypertension.
The device will be used in the usual care process in the centers involved in this registry. Patients will be followed for a year.The study is an observational study that will only collect data from the use of the device as standard of care. The procedure itself with the Eagle device is not part of the registry study.
The device is CE marked and is available on the European and UK market and is already being used by the Eye Care professionals. Data collected will be used post-market surveillance, which is a requirement from the European regulation.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
24/WM/0052
Date of REC Opinion
28 Mar 2024
REC opinion
Favourable Opinion