Artificial eyes Eye Diseases
Conditions
Interventions
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: r
Sponsors
Leeds Teaching Hospitals NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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)
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactJude Watson
Outcome results
None listed