Image Collection on Optos P200TE for development of EU RDB version 1
Research type
Research Study
Full title
Image Collection of normal eyes on the Optos P200TE for development of an EU Reference Database
IRAS ID
255649
Contact name
Tunde Peto
Contact email
Sponsor organisation
Optos plc
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 29 days
Research summary
Optos recently launched a new eye-imaging medical device which is now CE marked and is called the Optos P200TE. This machine is a non-contact ophthalmic camera that can take both OCT (Optical Coherence Tomography) and Scanning Laser Ophthalmoscope (SLO) images. OCT provides very detailed images of the different layers of the light sensitive part of the eye while SLO gives information on the health of the nourishing layer of the retina. This camera uses light to take pictures of the inside of the eye and measurements that can help doctors with diagnosing and treating eye conditions. The device does not touch the eye.
The proposed study is sponsored by Optos and will involve taking scans of normal eyes, at up to four clinics in the United Kingdom on the P200TE OCT in order to create a reference database for normal eyes. This database is needed, so a patient's images can be compared to healthy eyes. The reference database provides the clinician with a description as to how a normal eye should look in different age-groups. Cut-off values can be determined on the database and if a patient’s measurements fall outside of these cut-offs, the software can flag the measurement as falling outside the normal range. This information is combined with other clinical information to aid the clinician in the diagnosis and management of various ocular diseases.
REC name
HSC REC A
REC reference
19/NI/0085
Date of REC Opinion
16 Apr 2019
REC opinion
Further Information Favourable Opinion