MAR 08, 2016
FDA
Glaucoma
The Triggerfish (Sensimed AG) contact lens has a built-in sensor that could help identify patients at higher risk of glaucoma progression by automatically recording continuous eye pressure changes over the course of 24 hours.
The single-use soft silicone contact lens measures IOP fluctuations and transmits the data wirelessly to an adhesive antenna worn around the eye. The data is collected on a portable device worn by the patient and transmitted to the clinician’s computer using Bluetooth technology. The device does not directly measure IOP, but rather IOP fluctuations, showing the range of time during the day that eye pressure may be increasing.
“The Triggerfish gives the clinician 24-hour continuous monitoring of changes in IOP patterns that otherwise could not be obtained,” said William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “This information can help determine the most critical time of day for the clinician to measure the patient’s IOP.
The Triggerfish is indicated for use in adults age 22 and older under the direction and supervision of a health care professional. The FDA based its approval on several studies supporting the safety, tolerability and effectiveness of the lens. The most common temporary adverse effects were pressure marks from the contact lens, ocular hyperemia and punctate keratitis.
In the latest study, which will be published in Ophthalmology next month, investigators from Columbia University Medical Center tested the lenses on 40 patients between ages 40 and 89 undergoing treatment for open-angle glaucoma. During 2 years of follow-up, scientists performed at least 8 standard visual field tests on these patients. Half were classified as having slow disease progression, the other half, fast progression. They found that patients with steeper spikes recorded overnight and a greater number of peaks in their signal profile overall tended to have faster glaucoma progression.