A Retrospective Review of the Hydrus Implant
Research type
Research Study
Full title
A Retrospective Review of the Effectivness of the Hydrus Aqueous Implant on Intraocular Pressure Control.
IRAS ID
190623
Contact name
David Charles Broadway
Contact email
Sponsor organisation
Norfolk & Norwich University Hospital
Duration of Study in the UK
0 years, 0 months, 29 days
Research summary
The study will establish the effectiveness of the Hydrus Aqueous Implant in lowering eye pressure in patients with primary open-angle glaucoma who have undergone concurrent cataract surgery. The insertion of the CE marked Hydrus implant is a surgical method being investigated by Ivantis Inc. using a randomised controlled trial at the Norfolk & Norwich University Hospital. Some patients ineligible for the study but still suitable for a Hydrus implant had surgery carried out for control of intraocular pressure (IOP). For the present study, data will be collected from patients who received a Hydrus implant but were not participating in the randomised controlled trial. Thus, patients in the proposed study cohort received the implant during the 'surgeon training phase' or because they were not eligible to participate in the randomised controlled study and as such their data can be audited as a separate case review study.
Patients receiving the Hydrus implant outside of the study protocol gave consent to the surgical procedure but not specifically for collection of their medical information for the purposes of a retrospective case review. Whilst the data collection process can be undertaken as an audit, because the surgical intervention is not current standard practice within our Trust and only made available due to commercial research activity, the audit requires Ethical Approval. The data resulting from the audit may be presented at an international opththalmology conference or publication in a peer reviewed medical journal.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
15/EM/0564
Date of REC Opinion
9 Dec 2015
REC opinion
Favourable Opinion