A clinical trial of Sapphire II, an eye testing system designed to aid in the diagnosis of Alzheimer's disease, was successful, Cognoptix announced last week.
The results were published in the Journal of Alzheimer's Disease & Other Dementias.
Kerbage and colleagues utilized a fluorescent ligand eye scanning technique in 20 patients with Alzheimer's disease and 20 patients without the disease, according to the study. The Sapphire II eye test demonstrated a sensitivity of 85% and a specificity of 95% by differentiating the patients via the detection of a beta-amyloid signature in their eyes, according to the press release.
“The easy-to-use Sapphire eye test has demonstrated the clinical potential to remake the paradigm for the way in which Alzheimer’s disease is currently diagnosed and managed,” Carl Sadowsky, MD, FAAN, medical director of the Premiere Research Institute at Palm Beach Neurology in West Palm Beach, Fla., and a principal investigator in the clinical trial of the Sapphire eye test, said in the release.
The Sapphire II has been classified as a device/drug combination product by the U.S. Food and Drug Administration. It consists of a laser-based reading device and a consumable ophthalmic ointment, according to Cognoptix.
As reported in the press release, the Sapphire II testing system is approved only for investigational use in the U.S.
Primary Care Optometry News has previously reported that the eye test may allow doctors to diagnose Alzheimer’s disease before patients become symptomatic, allowing for more effective treatment.