A cross-over, randomised feasibility study of digitally-printed versus hand-painted artificial eyes in adults (PERSONAL-EYE-S): health economic findings.

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All Authors

Ronaldson, S.
Coleman, E.
Woodward, A.
Zoltie, T.
Bartlett, P.
Wilson, L.
Archer, T.
Kawalek, J.
Boele, F.
Chang, B.

LTHT Author

Bartlett, Paul
Wilson, Laura
Archer, Tom
Chang, Bernard
Kalantzis, George
El-Hindy, Nabil
Walshaw, Emma
Gout, Taras

LTHT Department

Leeds Dental Institute
Dental & Maxillofacial Radiology
Artificial Eye Service
Head & Neck
Ophthalmology

Non Medic

Prosthetist
Clinical Photographer

Publication Date

2025

Item Type

Journal Article

Language

Subject

Subject Headings

Abstract

BACKGROUND: Technology advances mean alternatives to hand-painted artificial eyes are possible, but the feasibility of conducting a large-scale trial is unknown. The aim was to assess the feasibility of collecting healthcare resource use and associated costs needed to undertake a large-scale randomised controlled trial (RCT) comparing the effectiveness and cost-effectiveness of hand-painted artificial eyes with digitally-printed artificial eyes. METHODS: Participants wore a digitally-printed artificial eye and a hand-painted artificial eye, for two weeks each, in a random order. Individual patient-level data was used to explore health outcomes (EQ-5D-5L) and resource use. Costs of the two artificial eye services were collected. A full economic evaluation was not conducted. An appropriate economic evaluation framework was developed to identify the relevant health economic data necessary for a future full trial. RESULTS: Thirty-five participants were randomised. Response rates were 97-100% for the EQ-5D-5L. Resource use questions were less well completed: 54% complete responses at baseline, 40% partial responses and 6% missing/invalid responses. The two follow-up points had similar rates. Eye services cost data were well completed. Mean utility was 0.77 after wearing the hand-painted eye and 0.83 after the digitally-printed eye. Average manufacturing times were 294 min (digitally-printed) and 355 min (hand-painted). Remake appointments were needed for digitally-printed eyes only. Estimated cost for the digitally-printed eye service is 404 and 347 for the hand-painted eye. Time between fitting and final evaluation was 56 days (digitally-printed eye) and 60 days (hand-painted). Results should be interpreted with caution, as estimates were based on a small sample. CONCLUSION: It was possible to collect EQ-5D-5L, healthcare resource use and manufacturing times allowing a costing to be calculated. Thus, a large-scale RCT with full cost-effectiveness analysis would feasible. Refinements are suggested. Future economic analysis should consider how best to evaluate the service, possibility with modelling rather than within-trial analysis only. TRIAL REGISTRATION: ISRCTN85921622.

Journal

Pilot & Feasibility Studies