A small-scale study to investigate whether it is possible to conduct a large study comparing digitally printed artificial eyes to hand-painted eyes

INTERVENTION: PERSONAL‐EYE‐S is a cross‐over randomised controlled, open feasibility study. The researchers will randomise people with a longstanding artificial eye who require a replacement artificial eye to: A: receive a digitally printed artificial eye first (intervention), followed by a hand‐painted artificial eye (control) B: receive a hand‐painted artificial eye first, followed by a digitally printed artificial eye. The study has a 3‐month recruitment period. Follow‐up will be conducted after the participant has used each type of eye. Participants will wear each eye for 2 weeks before follow‐up. Sample size: The proposed research is a feasibility study and therefore does not have a primary outcome measure to inform a sample size calculation. One of the aims of this cross‐over trial is to estimate the within‐subject standard deviation for each outcome measure, in order to inform the sample size calculation for a future study. It has been recommended in the pilot and feasibility trial literature that a sample size of between 24 and 70 is required for standard deviations to be reliably estimated. The researchers aim to recruit 35 eligible patients, which, assuming a 15% attrition rate, would allow for 30 patients in the final analysis. Recruitment and randomisation: Prospective participants will be identified via three main methods: during a routine ophthalmology clinic visit, via screening of the patient database by the ophthalmology clinic, or via notification placed on the websites of two relevant organisations (Blind Veterans UK, and Royal National Institute of Blind People). Participants will be given an information pack including CONDITION: Artificial eyes ; Eye Diseases PRIMARY OUTCOME: ; Feasibility outcomes relating to the acceptability of the trial intervention and procedures, resource use; Timepoint(s): After each intervention:; 1. Recruitment rate is defined as the proportion of eligible participants who are randomised onto the trial. Data will be collected on:; 1.1. Number of eligible patients; 1.2. Proportion of eligible patients approached for consent; 1.3. Proportion of eligible patients not approached for consent and reasons why; 1.4. Proportion of patients approached who provide consent; 1.5. Proportion of patients approached who do not provide consent and reasons why; Feasibility will be assessed based on whether the study consent/retention rates and proposed sample size indicates recruitment for the full‐scale RCT is plausible within a reasonable time frame; 2. Attrition rate is defined as the proportion of patients dropping out between randomisation and follow‐up. Data will be collected on:; 2.1. The proportion of randomised participants withdrawing from the study; 2.2. The proportion of randomised participants lost to follow‐up; 2.3. Where possible, reasons for withdrawal from the study; Feasibility will be assessed based on the attrition rate, where an attrition rate of <=15% is feasible as is, 20‐25% is feasible with additional measures in a full trial, and >25% is infeasible.; 3. Missing outcome data will be used to assess the feasibility of gathering patient‐reported outcome measures and other outcome measures at baseline and follow‐up. Measures with over 10% missing data may be modified/replaced prior to the main trial.; SECONDARY OUTCOME: ; Measured at baseline, after wearing the first allocated eye (T1 ‐ clinic visit 3) and after wearing the second allocated eye (T2 ‐ clinic visit 5):; 1. Health‐related quality of life and utility data measured by:; 1.1. Short‐form 36; 1.2. The EuroQol‐5 dimensions‐5 levels (EQ‐5D‐5L); 1.3. Impact of vision loss on quality of life: Vision Quality of Life Index (VisQol); 2. Resilience measured by Connor‐Davidson Resilience Scale‐10 (CD‐RISC‐10); 3. Distress and difficulties in living with a disfigurement measured by Derriford Appearance Scale short form (DAS24); 4. Participant satisfaction measured using a brief, bespoke study‐specific questionnaire; 5. Resource use data measured by a participant‐reported bespoke questionnaire; 6. Feasibility data collected by qualitative methods which include interviews with participants and close contacts. This will be conducted only after participants have completed both interventions; INCLUSION CRITERIA: 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)