A small-scale study to investigate whether it is possible to conduct a large study comparing digitally printed artificial eyes to hand-painted eyes
- Conditions
- Artificial eyesEye Diseases
- Registration Number
- ISRCTN85921622
- Lead Sponsor
- eeds Teaching Hospitals NHS Trust
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 35
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method