CLARITY Imaging Study
Research type
Research Study
Full title
CLARITY Imaging Study: The Effect Of Cross-linked Sodium Hyaluronate On The Quality Of Optical Coherence Tomography Imaging
IRAS ID
256498
Contact name
Timothy Yap
Contact email
Sponsor organisation
Imerial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 29 days
Research summary
Optical coherence tomography is an imaging technique wisely used in the field of ophthalmology to image the retinal layers at the back of the eye. This is crucially important for detecting evidence of conditions such as glaucoma and macular degeneration.
As the imaging technique uses light energy, it is crucial the path of light in and out of the eye is optically transparent in order to provide the highest resolution possible. However, often in cases of dry eyes or ocular surface disease, images can be of substandard quality. This may lead clinicians to drawing incorrect conclusions about the presence or absence of disease progression, and therefore substandard care for patients.
The study we are proposing will simply compare cross-linked sodium hyaluronate lubricant eye drops already licensed for use, with blinking alone or nothing. The subject will blink 5 times and the eyedrops will be instilled into one randomly selected eye in order to determine whether this intervention improves the quality of images compared to blinking alone. We will use a masked examiner, and objective signal strength scores to determine whether images taken before or after the addition of cross-linked lubricants are of higher quality. Secondary outcomes will also count the rate of errors made by automated segmentation software.
REC name
London - City & East Research Ethics Committee
REC reference
19/LO/0067
Date of REC Opinion
15 Jan 2019
REC opinion
Favourable Opinion