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

eeds Teaching Hospitals NHS Trust0 sites35 target enrollmentJune 17, 2021

Overview

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37056714/ (added 17/04/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39095468/ (added 06/08/2024)

Registry

who.int

Start Date

June 17, 2021

End Date

September 30, 2022

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

eeds Teaching Hospitals NHS Trust

•1\. Aged \=18 years
•2\. Longstanding artificial eye user (at least 12 months post\-operation)
•3\. Requires a replacement artificial eye (can be due to a variety of reasons such as wear and tear; damage; loss, change in fitting, clinician opinion; unhappy with their current artificial eye)
•4\. Be able to self\-complete the English language outcome measure tools (or can complete with assistance)

•1\. Ongoing clinical concerns with respect to their artificial eye use, such as poor eye socket healing, infections, extrusion, dehiscence
•2\. Lacks capacity or willingness to provide consent to participate in the study
•3\. Pregnant women or persons currently shielding (due to ongoing COVID\-19 pandemic, to avoid unnecessary visits to the clinic)
•4\. Is currently participating in another study evaluating their artificial eye
•5\. Has been previously recruited for this study
•6\. Has bilateral artificial eyes
•7\. Is deemed to be not clinically appropriate to take part in the study (at clinician discretion)