A cross-over, randomised feasibility study of digitally printed versus hand-painted artificial eyes in adults: PERSONAL-EYE-S - a study protocol

NIHR Open Res. 2023 Mar 15:2:50. doi: 10.3310/nihropenres.13311.2. eCollection 2022.

Abstract

Background/objective: Around 11,500 artificial eyes are required yearly for new and existing patients. Artificial eyes have been manufactured and hand-painted at the National Artificial Eye Service (NAES) since 1948, in conjunction with approximately 30 local artificial eye services throughout the country. With the current scale of demand, services are under significant pressure. Manufacturing delays as well as necessary repainting to obtain adequate colour matching, may severely impact a patient's rehabilitation pathway to a normal home, social and work life. However, advances in technology mean alternatives are now possible. The aim of this study is 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.

Methods: A cross-over, randomised feasibility study evaluating a digitally-printed artificial eye with a hand-painted eye, in patients aged ≥18 years with a current artificial eye. Participants will be identified in clinic, via ophthalmology clinic databases and two charity websites. Qualitative interviews will be conducted in the later phases of the study and focus on opinions on trial procedures, the different artificial eyes, delivery times, and patient satisfaction.

Discussion: Findings will inform the feasibility, and design, of a larger fully powered randomised controlled trial. The long-term 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 will allow the transition of research findings into benefit to patients locally in the short term and National Health Service wide in the medium to long term.

Isrctn registration: ISRCTN85921622 (prospectively registered on 17/06/2021).

Keywords: artificial eyes; cross-over; feasibility; health economics; qualitative; quality of life.

Plain language summary

Aims of the research: A large-scale study is needed to see how traditional hand-painted artificial eyes compare with digitally-printed eyes in terms of patient satisfaction and cost. Before that, this smaller study is needed to show whether people would take part, are happy to provide health information, and learn what they liked and did not like about taking part. Background to the research: After operations to remove a diseased or blind, painful eye many patients suffer from anxiety and depression. Returning to normal family, social and work life can be difficult. Artificial eyes have been hand-painted at the National Artificial Eye Service since 1948. Each eye takes over six weeks to make. Technology advances mean alternatives are now possible. A digital photograph of the unaffected eye printed onto specialised paper and pressed onto the artificial eye is simpler and faster. Although the printed eye appears more life-like, there is no research evidence to show whether patients prefer it, the process can be done on a larger scale or save the National Health Service (NHS) money. Design and methods: Thirty-five adults will be invited to participate. A computer will randomly select which artificial eye type (hand-painted or printed) they will receive first. After wearing the first eye for two weeks, they will wear the other type. Using questionnaires before and after wearing each eye, we will ask patients how satisfied they were with each eye, and how it affected their confidence and well-being. We will also interview some patients and family members to get a better understanding of their thoughts. We will also measure eye production times and costs. Dissemination: Results will be presented at ophthalmology conferences. Study findings will be made available to participants, patient groups, NHS commissioners and reported on relevant patient-focused websites.

Grants and funding

This project is funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme [Grant Reference Number NIHR201559]. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.