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Background <p>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.</p> Methods <p>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.</p> Results <p>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.</p> <p>Mean utility was 0.77 after wearing the hand-painted eye and 0.83 after the digitally-printed eye. Average manufacturing times were 294&#xa0;min (digitally-printed) and 355&#xa0;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&#xa0;days (digitally-printed eye) and 60&#xa0;days (hand-painted). Results should be interpreted with caution, as estimates were based on a small sample.</p> Conclusion <p>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.</p> Trial registration <p>ISRCTN85921622.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月3日

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  • Sarah Ronaldson,
  • Elizabeth Coleman,
  • Amie Woodward,
  • Tim Zoltie,
  • Paul Bartlett,
  • Laura Wilson,
  • Tom Archer,
  • Jessica Kawalek,
  • Florien Boele,
  • Bernard Chang,
  • George Kalantzis,
  • Michael Theaker,
  • Nabil El-Hindy,
  • Emma Walshaw,
  • Taras Gout,
  • Judith Watson

摘要

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.