Click2Print Artificial Eyes
NCT05093348 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99
Last updated 2023-11-30
Summary
To undertake a randomised crossover trial in human subjects the Click2Print ocular prosthesis versus an analogue ocular prosthesis demonstrating non-inferiority in the assessment of ocular prosthesis motility, cosmesis, fit and function, comfort, mucous discharge and benefits of use in daily life in 40 data subjects (Crossover Trial).
Conditions
- Enucleated; Eye
- Evisceration; Traumatic, Eye
Interventions
- DEVICE
-
Click2Print artificial eye
Digitally designed and manufactured ocular prosthesis
- DEVICE
-
Hand-made artificial eye
Hand-made artificial eye
Sponsors & Collaborators
-
Moorfields Eye Hospital NHS Foundation Trust
lead OTHER
Principal Investigators
-
Mandeep Sagoo · Moorfields Eye Hospital NHS Foundation Trust
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-11-25
- Primary Completion
- 2023-07-16
- Completion
- 2023-07-16
Countries
- United Kingdom
Study Locations
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