Tired of Wearing Reading Glasses? There's a New Device for That

The FDA recently approved a device implanted in the cornea of one eye to improve near vision in certain patients with presbyopia, a condition associated with aging in which the eye progressively loses the ability to focus on near objects.

The Raindrop Near Vision Inlay is the second FDA-approved implantable corneal device for correction of near vision in patients who haven’t had cataract surgery and the first implantable device that changes the shape of the cornea to achieve improved vision.

Presbyopia usually occurs in patients in their mid-40s or 50s due to normal aging. Most patients only become aware of presbyopia when they have to start holding books and other objects at arm’s length to be able to read them.

Eventually, nearly everyone develops symptoms and may require some method of near vision correction.

Reading glasses, bifocals, and contact lenses are common correction methods. However, corneal inlay surgery is an elective option for those who may not want to wear glasses or contacts.

“Given the prevalence of presbyopia and the aging of the baby boomer population, the need for near vision correction will likely rise in the coming years,” said William Maisel, MD, MPH, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, in a press release. “The Raindrop Near Vision Inlay provides a new option for surgical, outpatient treatment of presbyopia.”

The newly approved device is a clear hydrogel material resembling a microscopic contact lens, though it’s smaller than the eye of a needle. It’s indicated for patients 41 to 65 years who, in addition to not having had cataract surgery, are unable to focus clearly on near objects or small print and need reading glasses with +1.50 to +2.50 diopters of power, but don’t need glasses or contacts for clear distance vision.

To insert the device, an eye surgeon uses a laser to create a flap in the cornea of the patient’s non-dominant eye, implants the device into the opening, and puts the flap back in place. The inlay provides a steeper surface that can help the eye focus on near objects or print. The natural lens of the eye typically performs this function by changing shape, but in patients with presbyopia, the lens becomes hardened and ineffective at focusing on close-up objects, which causes poor near vision. By reshaping the curvature of the cornea, the inlay corrects the refractive error that results in near vision problems.

In one clinical trial designed to measure safety and effectiveness, 373 subjects were implanted with the Raindrop Near Vision Inlay device, and 2 years after implantation, 92% of them were able to see with 20/40 vision or better at near distances with the inlay-implanted eye.

Risks associated with device implantation are worsening problems with glare, halos, foreign body sensation and pain, as well as infection, inflammation, dry eye, retinal detachment, and a decrease in distance vision. The device may cause complications of the cornea, such as corneal scarring, swelling, inflammation, thinning, clouding, or melting. It may also cause certain tissue in the eye to grow into the cornea (epithelial ingrowth), causing clouding. Some patients may require a second surgery to remove or replace the inlay.

The device isn’t recommended for patients who:

• Have severe dry eye or an active eye infection or inflammation
• Exhibit signs of corneal disease characterized by general thinning and cone-shaped protrusion in the center of the cornea (keratoconus)
• Have abnormal features of the cornea being implanted
• Have certain autoimmune or connective tissue diseases
• Don’t have enough corneal thickness to withstand the procedure
• Have a recent herpes eye infection or problems resulting from a previous infection
• Have uncontrolled glaucoma or uncontrolled diabetes