FDA Nod for Second Implantable Corneal Device to Treat Near Vision
The U.S. Food and Drug Administration (FDA) approved the second implantable corneal device, Raindrop Near Vision Inlay for the correction of near vision in patients with presbyopia.
Raindrop Inlay is the first implantable device that alters the shape of the cornea by changing its anterior curvature to improve the near vision in presbyopic patients. The device is manufactured by California based ReVision Optics Inc.
Figure 1. Raindrop® Near Vision Inlay creates a prolate-shaped cornea (photo credit: ReVision Optics, Inc).
Presbyopia is a common eye-related disorder which occurs due to aging. Gradually with age, hardening occur in the natural lens due to which the person becomes unable to focus properly on the near objects due to refraction in the eye.
Figure 2. Difference between normal vision and presbyopia (photo credit: goodlookingoptics.co.uk).
It might be seen in patients along with other refractive disorders like hypermetropia (farsightedness), myopia (nearsightedness), and astigmatism. Eyeglasses have been the easiest and safest means of correcting presbyopia.
The Raindrop Near Vision Inlay is a device made up of a material like a hydrogel and looks like a tiny contact lens. It looks even smaller than a needle’s eye. It is designed to be used by patients in the age group of 41 to 65 years.
Along with it, the patient should never have had a cataract surgery and should be unable to focus clearly on near objects or small print and needs reading glasses with +1.50 to +2.50 diopters of power but does not need glasses or contacts for clear distance vision.
The surgeons open a small area of the cornea by a laser in the patient’s non-dominant eye, implants the device and again close the opened area. The inlay changes the anterior curvature of the cornea and provides the proper bulge to the surface which helps the eye to focus on closer objects.
Figure 3. Procedure of implantation of the Inlay (photo credit: dailymail.co.uk).
373 subjects implanted with the device demonstrated the safety and effectiveness of the Raindrop Near Vision Inlay. In a small span of just 2 years of the implantation, 92 percent patient’s inlay-implanted eye (336 out of 364) were able to see with 20/40 vision or with improved near vision.
This implantation may cause or worsen problems with infections, inflammations, a new dry eye disorder or aggravation of an already existing dry eye disease, Keratoconus.
Figure 4. Oxygen concentration in cornea treated with or without Raindrop (photo credit: ReVision Optics, Inc).
The Inlay is not recommended for patients who have existing eye disorders pertaining to the cornea and retina. Also, it’s a big NO-NO for patients who have had a herpes eye infection lately and also for them who have unrestricted glaucoma or uninhibited diabetes.
“The Raindrop Near Vision Inlay provides a new option for surgical, outpatient treatment of presbyopia.”, said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health.
Featured image credit: Digital illustration of eye. © krishnacreations (Stock Photo ID: 60066608)