RESUMEN
BACKGROUND/OBJECTIVES: Over 60,000 patients in the United Kingdom are estimated to have artificial eyes. Manufacturing and hand-painting of artificial eyes have not changed significantly since 1948. Delays and colour-matching issues may severely impact a patient's rehabilitation pathway. Technology advances mean alternatives are now possible. This cross-over, randomised feasibility trial aimed to determine the feasibility of conducting a full-scale trial of the effectiveness and cost-effectiveness of digitally-printed artificial eyes compared to hand-painted. SUBJECTS/METHODS: Patients aged ≥18 years who were longstanding artificial eye users requiring a replacement were randomised to receive either a hand-painted or digitally-printed eye first followed by the other type of eye. Participants were asked to approach a close contact (CC) willing to participate alongside them. A subset of participants, their CCs, and staff were interviewed about their opinions on trial procedures, artificial eyes, delivery times and satisfaction. RESULTS: Thirty-five participants were randomised and 10 CCs consented. Participant retention at final follow-up was 85.7%. Outcome data completion rates ranged from 91-100%. EQ-5D-5L completion ranged from 83-97%. Resource-use completion ranged from 0-94% with total costs at £347 for hand-painted and £404 for digitally-printed eye. There were two adverse events. Twelve participants, five CCs, and five staff were interviewed. There were positive and negative features of both types of eyes. We identified that social and psychological wellbeing is affected, often for many years after eye removal. Participation in the feasibility study was well accepted. CONCLUSIONS: The feasibility study outcomes indicate that a full trial is achievable. TRIAL REGISTRATION NUMBER: ISRCTN85921622.
RESUMEN
Background/objectives: 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).