The FDA has given the green light to Switzerland-based Sensimed AG for its Triggerfish, a contact lens embedded with a sensor that detects changes in an eye’s volume.
The FDA says the device could help identify the most critical time of day to measure intraocular pressure. Elevated eye pressure is associated with nerve damage common in glaucoma.
“IOP varies throughout the day and may not be abnormally high when the patient is at an eye care professional’s office having an eye exam,” the FDA says.
The Triggerfish is worn for a maximum of 24 hours, transmitting data wirelessly from the embedded sensor to an adhesive antenna that transfers information to a portable data recorder.
The device does not actually measure intraocular pressure, and is not intended to be a diagnostic tool.
The approval is based on clinical data showing an association between the device output and intraocular pressure fluctuation. The most common temporary side effects were pressure marks from the contact lens, red eyes and cornea irritation.
The FDA reviewed the data through the de novo premarket review pathway. — Jonathon Shacat