Live-OCT Study, V1.0
Research type
Research Study
Full title
Clinical Study of an Ultrasensitive Optical Coherence Tomography (OCT) Device to Improve the Management of Eye Disease
IRAS ID
292051
Contact name
Stephen Kaye
Contact email
Sponsor organisation
University of Liverpool
ISRCTN Number
ISRCTN35255420
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
We have invented a new higher resolution Optical Coherence Tomography (OCT) scanner which will allow us to see the layers of the cornea in more detail than is possible with devices currently used in clinic. Optical Coherence Tomography (OCT) uses technology which shines light at the cornea and then captures the light that reflects off the corneal layers to produce a cross sectional image. We have developed 2 slightly different versions: D1 and D2. The devices only differ slightly in their internal optical arrangements, and the image produced, and user and patient experience will be identical.
We plan to evaluate and optimise the devices and data analysis on participants with the corneal diseases Keratoconus and Fuchs Endothelial Corneal Dystrophy (FECD)/lamellar surgery and those without any known corneal condition. It is a proof of concept observational study for which we hope to demonstrate clinical utility for diagnosis disease classification and management. We will compare the performance of our Live-OCT devices to the scanners currently used in clinic (corneal topography and tomography devices), focusing on precision and accuracy based on currently accepted clinical standards. We will also obtain feedback on patient experience. We will compare the costs of using the new scanner in clinic with existing scanners and compare this with a range of outcomes from an NHS perspective.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
21/YH/0132
Date of REC Opinion
10 Aug 2021
REC opinion
Further Information Favourable Opinion