Title: A novel high-definition PERSONALised artificial EYE Service (PERSONAL-EYE-S)
Funder: Department of Health and Social Care

Abstract: Background Over 60,000 patients in the United Kingdom are estimated to have artificial eyes and around 11,500 artificial eyes need to be made each year to meet demand from both new and existing patients, who need regular replacements. The main reason for surgical removal of a blind painful eye is cancers, trauma and congenital conditions. Artificial eyes have been hand-painted at the National Artificial Eye Service (NAES) since its integration into the National Health Service (NHS) in 1948. In addition to national service there are around 30 local artificial eye services throughout the country. Given the current scale of demand, both national and local services are under significant and increasing pressure. Manufacture can take over six weeks; some NAES patients have reported waiting up to 1 year as multiple re-paintings are often required for adequate colour matching. This may severely impact a patient s rehabilitation pathway to a normal home, social and work life. Advances in technology mean alternatives are now possible. Aims and objectives This study aims to establish the feasibility of conducting a large-scale study of the effectiveness and cost-effectiveness of digitally printed artificial eyes compared to hand-painted eyes. We will explore the current use of NHS services in comparison to the novel artificial eye service provision developments to date. Methods A cross-over randomised feasibility study in a single centre in England, evaluating service provision of a novel digitally printed artificial eye with the existing hand-painted eye in patients aged &ge;18years currently with an artificial eye that requires replacing. Participants will be identified via ophthalmology clinic databases and various charity websites. Following baseline measurements patients will be randomised to receive either a standard hand-painted or a digitally printed eye first, followed by wearing the other. We will measure eligibility and recruitment rates; determine study acceptability, collect data related to health status, impact of vision loss, resilience, appearance and NHS resource use at baseline and following use of each eye; and assess the feasibility of collecting patient-reported outcome measures. A subset of patients will also be invited to attend a one-to-one interview to discuss their experience of participating in the study. The data collected from all elements of the study will be used to determine the feasibility of a future trial. Timelines for delivery The study duration would be 18months in total: 4months to set up; 3months for recruitment, 6months for manufacture and data collection, 5months for final analysis and write up final report. However, the two evaluation streams have analysis and write up components in-built throughout the trial as seen in the Gantt chart. Anticipated impact and dissemination Our overall aim is to create a more life-like artificial eye in order to improve patients initial rehabilitation pathway, long term quality of life, and service experience. This feasibility study will inform a full study on effectiveness and cost-effectiveness. This will allow the transition of research findings into benefit to patients locally in the short term and NHS wide in the medium to long term.

Lay abstract: Background After operations to remove a diseased or blind, painful eye many patients suffer from anxiety and depression. The physical and mental trauma of losing an eye is challenging. Returning to normal family, social and work life can be difficult. Artificial eyes have been hand-painted at the National Artificial Eye Service since its integration into the National Health Service (NHS) in 1948. Each eye takes over six weeks to make. Technology advances mean alternatives are now possible. Digital photography of the unaffected eye and printing onto specialised adhesive paper pressed onto the artificial eye is simpler and faster than hand-painting. Although the digitally printed eye appears to be more life-like, there is no research evidence to show whether patients prefer it or whether this process can be replicated on a larger scale and save the NHS money. Aim To see if it is possible to do a large study comparing digitally printed artificial eyes with hand-painted eyes. Methods We will first look at the steps involved by running this smaller trial, including whether we can get people to take part, collect information about their health, and ask what they liked and did not like about taking part. Thirty-five adults from across England who need a replacement artificial eye will be invited to participate. A computer will randomly select which artificial eye type (hand-painted or printed) they will be given first. Once they have worn the first eye for two weeks, they will wear the other type. Before, and after wearing each artificial eye, we will ask patients how satisfied they were with each eye, how it affected their confidence and well-being using questionnaires. We will also interview some patients and family members to get a better understanding of their thoughts. We will measure how long it takes for the eyes to be produced and how much they cost. Public involvement Patients and charities have helped us design this study. Our public co-applicant will sit on the study committee, advise on documents and provide input throughout the study. We will provide resources and support to our public co-applicant so we can build strong public involvement foundations for our larger study at a later stage. This will involve maintaining our strong patient and public involvement group, expanding the patient support group and building stronger ties with local and national charities. Dissemination Findings will be shared with participants, public, NHS commissioners and eye service staff through presentations, written reports, medical journals and conferences. Participants and their families are invited to participate in end-of-study events. A structured teaching programme for other eye service providers will allow them to learn about the new technology, growing our national and international collaborator network for a larger trial.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: EYE