IOP Monitoring Contact Lens - V001
Research type
Research Study
Full title
Contact Lens Device for Continuous Monitoring of Intraocular Pressure
IRAS ID
157140
Contact name
Ahmed Elsheikh
Contact email
Research summary
Glaucoma is a leading cause of irreversible blindness, affecting 500,000 people in the UK and costing the National Health Service (NHS) £1.1billion 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 due to changes in posture and physiologic state, and during sleep. To overcome this problem, it is necessary to monitor IOP continuously over a period of 24 hours or longer.
This project aims to develop a low-cost contact lens device that can continuously monitor IOP and concentrates on the design optimisation of the contact lens and its pressure sensors, the holistic development of the device components into an integrated clinical product, and the experimental and clinical validation of the device.
An experimental validation study, involving at least 18 human donor eyes, will be conducted at the University of Liverpool Ocular and Biomaterial Biomechanics Laboratory to assess the accuracy of IOP measurements made by the device. Donors with no history of human immunodeficiency virus, hepatitis B and C, syphilis, active infections, and eye tumours, abnormal topography or any form of eye injury or surgery will be considered for inclusion in the study. The donor eyes will be subjected to known levels of IOP within tightly-controlled experimental conditions of humidity and temperature, while using contact lens prototypes to produce IOP measurements. The differences between the applied and measured IOP values will help assess the accuracy of the device and its dependence on corneal mechanical stiffness, which will also be measured experimentally. The study will take place over a period of up to 18 months depending on suitable donor specimen availability.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
14/YH/1148
Date of REC Opinion
21 Aug 2014
REC opinion
Favourable Opinion