A novel, high-definition PERSONALised artificial EYE Service (PERSONAL-EYE-S): A cross-over, randomised feasibility study of digitally printed versus hand-painted artificial eyes in adults.

Over 60,000 patients in the United Kingdom are estimated to have an artificial eye equating to around 1 in 1,000 of the UK population. The National Artificial Eye Service (NAES) manufactures up to 5,000 artificial eyes each year. However, services are under increasing pressure due to demand, leading to delays in receiving first eyes and existing patients not receiving regular replacements.

A well fitted, life-like artificial eye helps rehabilitation. The NAES has hand-painted artificial eyes since its integration into the NHS in 1948. However, achieving a good colour match is difficult. Recently, digitally printed artificial eyes have been developed at Leeds Teaching Hospitals NHS Trust (LTHT). Early work demonstrates patients can receive a good match, with fewer clinic visits, and a shorter manufacturing time.

The study:

PERSONAL-EYE-S is a single centre, cross-over, randomised feasibility study to:

Assess whether it is feasible to conduct a future, full-scale RCT into the effectiveness and cost-effectiveness of digitally printed artificial eyes compared to hand-painted eyes.
To assess scalability, acceptability of the treatment and procedures, and to determine recruitment rates and barriers to participation.

Participants with one artificial eye will be invited to LTHT and randomised to wear either the hand-painted eye or the digitally printed eye first for two weeks, before then wearing the second eye for a further two weeks. Participant data will include questionnaires about wellbeing and quality of life, as well as interviews to explore experiences of the two treatments.

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Funding
Members

Funding

Funder(s):	NIHR Research for Patient Benefit Programme (RfPB) (NIHR201559)
Start Date:	December 2020
End Date:	May 2022

Funder(s):

NIHR Research for Patient Benefit Programme (RfPB)

(NIHR201559)

Start Date:

December 2020

End Date:

May 2022

Members

YTU Team:

Dr Jude Watson – Joint Lead Applicant
Ms Amie Woodward – Trial Co-ordinator
Ms Izzy Coleman – Trial Statistician

External Members:

Dr Taras Gout – Chief Investigator
Professor Bernard Chang – Co-applicant
Dr Florien Boele – Co-applicant
Mr Timothy Zoltie – Co-applicant
Dr Emma Walshaw – Co-applicant
Mr Paul Bartlett – Co-applicant
Mr George Kalantzis – Co-applicant
Mr Michael Theaker – Co-applicant
Mr Nabil El-Hindy – Co-applicant