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

Autor:	Gout T; Leeds Artificial Eye Service, Leeds Dental Institute, Leeds Teaching Hospitals NHS Trust, Worsley Building, Leeds, LS2 9LU, UK., Zoltie T; School of Dentistry, Faculty of Medicine and Health, University of Leeds, Worsley Building, Leeds, LS2 9LU, UK., Woodward A; York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK., Coleman E; York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK., Boele F; Leeds Institute of Health Sciences, Faculty of Medicine and Health, University of Leeds,, Leeds, LS2 9JT, UK.; Leeds Institute of Medical Research at St James's, St James's University Hospital, University of Leeds, Leeds, LS9 7TF, UK., Chang B; Department of Ophthalmology, Leeds Teaching Hospitals NHS Trust, Leeds, LS9 7TF, UK., Bartlett P; Leeds Artificial Eye Service, Leeds Dental Institute, Leeds Teaching Hospitals NHS Trust, Worsley Building, Leeds, LS2 9LU, UK., Ronaldson S; York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK., Kalantzis G; Department of Ophthalmology, Leeds Teaching Hospitals NHS Trust, Leeds, LS9 7TF, UK., Theaker M; Patient and Public Involvement representative, Leeds, UK., El-Hindy N; Department of Ophthalmology, Leeds Teaching Hospitals NHS Trust, Leeds, LS9 7TF, UK., Walshaw E; Leeds Artificial Eye Service, Leeds Dental Institute, Leeds Teaching Hospitals NHS Trust, Worsley Building, Leeds, LS2 9LU, UK., Watson J; York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK.
Jazyk:	angličtina
Zdroj:	NIHR open research [NIHR Open Res] 2023 Mar 15; Vol. 2, pp. 50. Date of Electronic Publication: 2023 Mar 15 (Print Publication: 2022).
DOI:	10.3310/nihropenres.13311.2
Abstrakt:	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). Competing Interests: Competing interests: All authors, with the exception of MT, have a proportion of their salaries covered by the research funding received. (Copyright: © 2023 Gout T et al.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu