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
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.
Lay summary of study results: The study investigated the thickness of the layers of the human cornea, in particular the thickness of Bowman's layer. Investigations were undertaken as to whether the thickness of Bowman's layer was associated with total central corneal thickness, age, diagnosis, sex and other parameters. The main finding was that Bowman's layer thickness was proportional to corneal thickness and that this ratio of central Bowman's layer to central corneal thickness, was independent of age and diagnosis for keratoconus, Fuchs endothelial corneal dystrophy and healthy controls.
Lay Summary:
The study investigated the thickness of the layers of the human cornea, in particular the thickness of Bowman's layer. Investigations were undertaken as to whether the thickness of Bowman's layer was associated with total central corneal thickness, age, diagnosis, sex and other parameters. The main finding was that Bowman's layer thickness was proportional to corneal thickness and that this ratio of central Bowman's layer to central corneal thickness, was independent of age and diagnosis for keratoconus, Fuchs endothelial corneal dystrophy and healthy controls.
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