US FDA OKs marketing of sensor contact lens that measures IOP

The lens may may help eye-care practitioners identify the best time of day to measure a patient’s intraocular pressure (IOP). Elevated IOP is often associated with the optic nerve damage that is characteristic of glaucoma.The Triggerfish, developed by Sensimed AG of Lausanne, Switzerland, has a sensor bedded in a soft silicone contact lens that detects tiny changes or fluctuations in an eye’s volume.
The device is worn for a maximum of 24 hours, transmitting data wirelessly from the sensor to an adhesive antenna worn around the eye. A portable data recorder worn by the patient receives information from the antenna and can transfer the data via Bluetooth to the clinician’s computer, which shows the range of time during the day the pressure of the eye may be increasing.
The device does not actually measure IOP, is not intended to be a diagnostic tool and is not used to correct vision, according to the FDA.
“The Triggerfish gives the clinician 24-hour continuous monitoring of changes in IOP patterns that otherwise could not be obtained,” Dr William Maisel, MD, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in a statent released by the FDA.
“This information can help determine the most critical time of day for the clinician to measure the patient’s IOP.”
Glaucoma affects an estimated three million Americans. Many patients have no symptoms until significant vision has been lost, and this loss is irreversible.
IOP varies throughout the day and may not be abnormally high when the patient is at an eye-care practitioner’s office having an eye examination. For example, it is common for IOP to increase during sleep when the patient is lying down.The Triggerfish is indicated for use in adults age 22 and over under the direction and supervision of a health-care professional.
Clinical data supporting the marketing authorisation of the lens included several studies of the safety and tolerability of the contact lenses and the effectiveness of the device measurent.