Contact Lens Device for Continuous Monitoring of Intraocular Pressure
Research type
Research Study
Full title
Contact Lens Device for Continuous Monitoring of Intraocular Pressure
IRAS ID
177033
Contact name
Simon Harding
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Glaucoma is a leading cause of irreversible blindness, affecting 500,000 people in the UK and costing the NHS £1.1 billion per year. Since a major risk factor for glaucomatous loss of vision is elevated intraocular pressure (IOP), the measurement of IOP is central to glaucoma management. The standard practice is to measure IOP over a few minutes during clinic visits, which is unlikely to be sufficient as IOP varies considerably throughout the day due to changes in posture and physiologic state, and during sleep. In the past patients were admitted to hospital for 4 hourly IOP testing over a 24 hour period but this has fallen out of regular practice due to inpatient and staff constraints. To overcome this problem, we have developed a device aimed at monitoring IOP continuously over a period of 24hr or longer and wish to conduct human volunteer investigations.
Two pilot clinical studies will be conducted in sequence at two clinical sites, St. Paul’s Eye Unit, Royal Liverpool University Hospital (SPEU) and Moorfields Eye Hospital (MEH). The studies will involve 12 and 20 participants, respectively – shared equally between the two sites, and will assess the suitability of a wireless contact lens device for extended wear and the reliability of its IOP measurements. Both studies will aim to collect continuous pressure readings over a 1 hour period. Data from the first study will guide the development of the software controlling the operation of the device, which will then be tested in the second study in a further cohort of volunteers and also people with glaucoma.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0087
Date of REC Opinion
17 May 2016
REC opinion
Further Information Favourable Opinion