The FDA issued approval to ReVision Optics, a company, for its Raindrop Near Vision Inlay, a device designed to reshape the cornea to help people with presbyopia see nearby objects.
The tiny hydrogel device is implanted in an outpatient procedure. It looks like a contact lens, but is only 2mm in width and 32 micrometers in thickness. A laser is used to create a flap within the cornea and position the Raindrop under it. The new shape of the cornea helps the eye adjust and focus, essentially doing something that a healthy eye should be doing on its own.
It was tested in a clinical trial of almost 400 people who received the implant, demonstrating that 92% of patients who were evaluated had 20/40 or better vision at near distances two years after the procedures.
It’s intended for people 41 to 65 years old who have not had cataract surgery, but who really don’t like wearing reading glasses.
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