How does the Occuity Pachymeter compare to the gold standard
Research type
Research Study
Full title
To establish whether the Occuity device is non inferior in its measurement of central corneal thickness compared to Accutome ultrasound pachymeter and Lenstar.
IRAS ID
305153
Contact name
James Kirwan
Contact email
Sponsor organisation
Occuit Limited
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
The Occuity device is a new handheld, non-contact, optical pachymeter, which utilise a low power, eye safe infrared (1310nm) beam to measure the corneal thickness.
The primary objective of this study is to establish whether the Occuity device is non-inferior in measuring the CCT when compared to the Accutome ultrasound pachymeter and Lenstar. This will be established by taking a CCT measurement with all three devices, in the same eye of the same patient sequentially to use as a direct comparison.
This is a prospective, observational, non-invasive, crossover study. The participants will undergo CCT measurement using the Occuity device, Lenstar device and then the Accutome ultrasound pachymeter. The latter two devices are standard devices regularly used in clinical practice. Measurement with ultrasound will occur last, as this will require instillation of anesthetic drops and may confound the values obtained by the non-contacting optical devices.
The participants will be recruited during a routine clinic visit, and only those who need to have a CCT measurement (with UP) as part of their routine care will be recruited. No additional visits will be required. The measurements will take place during their clinic appointment and will take approximately 30 minutes to complete.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
21/SC/0368
Date of REC Opinion
6 Jan 2022
REC opinion
Further Information Favourable Opinion