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Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Sponsor: University of Plymouth
Summary
The OCUTOP is a new hand-held camera that photographs the front of the eye to map the shape of the cornea and to assess the tear film. Before it can be used in eye care it must be compared with the instruments that clinics already use. In this study, adults attending one of two UK eye clinics for an ordinary appointment are invited to have both eyes measured once with the OCUTOP and with the clinic's usual instruments, in a random order, and to complete two short questionnaires. The visit adds about 30 minutes; nothing is put in the eye and no treatment is given. The study measures how closely the OCUTOP agrees with the reference instruments for corneal curvature, tear break-up time and tear meniscus height, how repeatable it is, how often it produces usable images, how acceptable participants and clinicians find it, and whether any adverse events occur.
Official title: Performance Evaluation of the OCUTOP Corneal Topographer With OCUGRAPH Software: Agreement With Reference Instruments, Repeatability and Safety in an Unselected Adult Clinic Population
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2027-01
Completion Date
2027-03
Last Updated
2026-10-26
Healthy Volunteers
Yes
Interventions
OCUTOP hand-held corneal topographer with OCUGRAPH software
Investigational hand-held, non-contact, Placido-based corneal topographer with integrated non-invasive tear-film assessment (tear break-up time and tear meniscus height), operated through the OCUGRAPH software on a Windows computer. The device rim rests on the skin around the eye; nothing touches the eye. Both eyes are imaged at one visit, with repeat captures for repeatability. The device is not UKCA or CE marked and is labelled exclusively for clinical investigation. Manufacturer: OCUWELL Limited.
Reference instrument measurement (corneal topography and tear-film assessment)
Corneal topography and non-invasive tear-film assessment with the CE or UKCA marked instruments in routine use at each site, used within their intended purpose: Pentacam HR (topography) and Keratograph 5M (tear film) at Site 01, with the Medmont E300 as an additional topographer; Myah (topography and tear film) at Site 02. Both eyes, same visit, repeat captures for repeatability.
Locations (2)
Simon Berry Optometrist
Durham, County Durham, United Kingdom
Centre for Eyecare Excellence, University of Plymouth
Plymouth, Devon, United Kingdom