Title: Binocular OCT – Reinventing the Eye Examination
Funder: Department of Health and Social Care

Abstract: BACKGROUND Chronic eye diseases are a major public health issue, with four diseases alone age-related macular degeneration (AMD), diabetic retinopathy, glaucoma, strabismus and amblyopia accounting for the bulk of visual impairment in the UK. With an ageing population, and the worldwide explosion in diabetes mellitus, the burden of these diseases is predicted to increase substantially in the next decade. Much of this burden to patients and the NHS may be ascribed to limitations of current eye examination. Patients with such conditions commonly require long-term monitoring, with frequent, time-consuming visits to the eye clinic. Current eye examination is also expensive and in many parts non-quantitative. A new form of diagnostic imaging termed binocular optical coherence tomography (OCT) has the potential to address these issues. Binocular OCT allows a range of diagnostic testing to be performed by a single device in an automated manner (i.e., without the need for additional personnel). Advances in OCT technology also allow non-invasive whole eye imaging in a potentially small and portable device. Thus, binocular OCT has the potential to reinvent the eye examination for the 21st Century. POTENTIAL BENEFIT TO PATIENTS AND THE NHS Binocular OCT has potential benefits in terms of: 1) increased efficiency of hospital eye services in the NHS, allowing patients with chronic eye disease to spend less time waiting during routine hospital eye examinations, 2) reduced costs for the NHS, through a reduction in the total number of diagnostic instruments required and their associated labour costs, and 3) improved quality of eye care, through the introduction of more, quantitative, standardised ocular measurements and high-resolution imaging. AIM The concept of binocular OCT was first described in 2009 (VIDEO http://goo.gl/mi7FyX), with development since 2011, and prototypes first manufactured in 2013. The aims of this award are to: 1) perform testing and clinical validation of this device in the NHS, and 2) to train the award applicant in diagnostic accuracy studies, medical devices, and new technologies for ophthalmology.PLAN OF INVESTIGATION This application will follow a progressive framework of diagnostic testing, with patients and the public playing a central role. In work package (WP) 1, human factor and usability testing will judge the ease of use and interactive qualities of the device, with a view to predicting likely function in a clinic setting. This patient-centred testing will allow optimisation of the operating software and workflow for use in visual impaired populations and the elderly. In WP2, early-stage diagnostic studies will assess the agreement, repeatability, and reproducibility of individual diagnostic features of the device, across a range of chronic eye conditions, by comparing their results with reference standards. Features tested will include: 1) visual acuity, 2) pupillometry, 3) health history and examination, 4) perimetry, and 5) ocular alignment and motility. In WP3, a health economic assessment will be performed to evaluate diagnostic resource use, direct medical costs, and patterns of care in a specific setting intravitreal therapy clinics for retinal diseases in the NHS. The resulting data will be used to estimate the potential cost savings and feasibility of binocular OCT implementation in the NHS. In WP4, a later-stage diagnostic study will be performed to assess the feasibility and effects of the binocular OCT system on clinical decision-making in patients receiving intravitreal pharmacotherapies for AMD. The results of this study will facilitate future plans for incorporation of binocular OCT into randomised clinical trials, and thus the assessment of its effects on clinical outcomes. In parallel, WP5 will assess the use of both conventional and binocular OCT for novel clinical applications and spin-off research in other ophthalmic subspecialties.

Lay abstract: Chronic eye diseases are a major cause of visual impairment and blindness in the UK. The need for long-term monitoring of these diseases, with frequent, time-consuming visits to hospital eye clinics, places a huge burden on both patients and the NHS. A new form of medical imaging device, termed binocular optical coherence tomography (OCT) has the potential to reinvent the eye examination for the 21st Century, and thus greatly improve the care of patients with these conditions. For this award, we propose testing the effectiveness of this device in hospital eye clinics in the NHS.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: EYE