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

Background/objectives: Around 11,500 artificial eyes are required yearly for new and existing patients. Artificial have been manufactured hand-painted at the National Eye Service (NAES) since 1948, in conjunction with approximately 30 local eye services throughout country. With current scale of demand, under significant pressure. Manufacturing delays as well necessary repainting to obtain adequate colour matching, may severely impact a patient’s rehabilitation pathway normal home, social work life. However, advances technology mean alternatives now possible. The aim this study is establish feasibility conducting large-scale effectiveness cost-effectiveness digitally printed compared eyes. Methods: A cross-over, randomised evaluating digitally-printed eye, patients aged ≥18 years eye. Participants will be identified clinic, via ophthalmology clinic databases two charity websites. Qualitative interviews conducted later phases focus on opinions trial procedures, different eyes, delivery times, patient satisfaction. Discussion: Findings inform feasibility, design, larger fully powered controlled trial. long-term create more life-like order improve patients’ initial pathway, long term quality life, service experience. This allow transition research findings into benefit locally short Health wide medium term. ISRCTN registration: ISRCTN85921622 (17/06/2021)