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

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.

Results: 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.

Conclusions: The feasibility study outcomes indicate that a full trial is achievable.

Trial registration number: ISRCTN85921622.