Evaluation of a novel camera for retinal imaging - Epicam
Research type
Research Study
Full title
Evaluation of a novel camera for retinal imaging - Epicam
IRAS ID
152586
Contact name
Craig Robertson
Contact email
Sponsor organisation
Epipole Limited
Duration of Study in the UK
0 years, 4 months, 0 days
Research summary
This study will evaluate the performance of a novel camera for taking images of the retina (the back of the eye). The camera has been designed to facilitate evaluation of diabetic retinopathy (the retinal complications that can occur due to diabetes), especially in rural areas of developing countries where there is limited access to healthcare. Whilst a variety of retinal cameras are available on the market, these are expensive and bulky, and therefore not accessible to this population of patients.
In contrast, the camera in this study is lightweight (approximately 500g) and inexpensive (less than £1,000 versus £10,000 plus for cheapest current competitors). The performance of the new camera has been tested on volunteers, in which the camera has obtained good quality images through undilated pupils, with no adverse effects. In order to proceed to market, it is necessary to demonstrate that the camera is able to detect retinal disease, with a performance comparable to existing cameras.
This study will evaluate image quality and diagnostic performance in patients with a range of severity of diabetic retinopathy, as well as differing amounts of cataract (haziness in the lens of the eye). Patients with diabetes who are already attending the eye clinic will be invited to participate via a postal invitation, with Patient Information Sheet, from their normal clinical care team. There will be a tear off slip on the invite letter that patients would hand in if they wished to meet with the research team. If they did so, and following informed consent, patients will undergo retinal imaging with two retinal cameras: the Epicam and a standard Canon Non-Mydriatic Camera, with pupil dilation if required). Images will be anonymised.
Photographs will be graded on standardised sheets with pre-determined diagnostic criteria. The performance of the cameras will be compared for technical failure, sensitivity & specificity.REC name
East of Scotland Research Ethics Service REC 2
REC reference
15/ES/0074
Date of REC Opinion
25 Aug 2015
REC opinion
Further Information Favourable Opinion