York Trials Unit, Department of Health Sciences, University of York, York, UK.
School of Dentistry, Faculty of Medicine and Health, University of Leeds, Leeds, UK.
Eye (Lond). 2024 Dec;38(17):3263-3271. doi: 10.1038/s41433-024-03273-0. Epub 2024 Aug 2.
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.
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.
The feasibility study outcomes indicate that a full trial is achievable.
ISRCTN85921622.
背景/目的：据估计，英国有超过 6 万名患者佩戴义眼。自 1948 年以来，义眼的制造和手绘技术并没有发生显著变化。延迟和配色问题可能严重影响患者的康复途径。技术进步意味着现在有了更多的选择。这项交叉、随机可行性试验旨在确定对数字化打印义眼与手绘义眼的有效性和成本效益进行全面试验的可行性。
受试者/方法：参与者为年龄≥18 岁、长期佩戴义眼需要更换的患者，他们被随机分配先接受手绘或数字化打印的义眼，然后再接受另一种类型的义眼。要求参与者接触一位愿意与他们一起参与的亲密接触者（CC）。一部分参与者、他们的 CC 和工作人员接受了关于试验程序、义眼、交付时间和满意度的访谈。
35 名参与者被随机分配，10 名 CC 同意参与。最终随访时的参与者保留率为 85.7%。结局数据的完成率范围为 91-100%。EQ-5D-5L 的完成率范围为 83-97%。资源使用的完成率范围为 0-94%，手绘义眼的总成本为 347 英镑，数字化打印义眼的总成本为 404 英镑。有两起不良事件。对 12 名参与者、5 名 CC 和 5 名工作人员进行了访谈。两种类型的义眼都有优缺点。我们发现，社会和心理福利会受到影响，通常在义眼移除后多年都会受到影响。参与者对可行性研究的参与度很高。
可行性研究结果表明，全面试验是可行的。
ISRCTN85921622。
