FDA OKs First Implant (Raindrop) to Reshape Cornea, Fix Vision

Disclosures

June 29, 2016

The US Food and Drug Administration (FDA) today approved a new device to help farsighted individuals who'd rather not wear glasses — a tiny, transparent implant that goes inside the cornea and reshapes it to improve vision.

The device, the Raindrop Near Vision Inlay (Revision Optics) is the first implant of its kind.

Made of a hydrogel material, the Raindrop Near Vision Inlay looks like a contact lens that could fit inside the eye of a needle. An eye surgeon inserts the device in the cornea of the patient's nondominant eye through a laser-cut flap. The inlay helps the eye focus on near objects or print by giving the cornea a steeper surface, making up for the inability of the patient's lens to change shape on account of presbyopia.

"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. "The Raindrop Near Vision Inlay provides a new option for surgical, outpatient treatment of presbyopia."

Last year, the FDA approved another implant — the KAMRA Inlay (AcuFocus) — that goes inside the cornea to correct presbyopia, but it does not reshape the cornea. Instead, the device improves short-distance vision by blocking unfocused, peripheral light rays and allowing central light rays to thread a small, 1.6-mm aperture in the center. Like the Raindrop Near Vision Inlay, the KAMRA Inlay is indicated for patients who have not had cataract surgery.

Complicated Indication and Contraindications

The latest device comes with a complicated indication and contraindications. The FDA has approved it for patients aged 41 to 65 years who can't focus clearly on near objects or small print and who need reading glasses with +1.50 to +2.50 diopters of power, but who otherwise do not need glasses or contacts for distance vision. However, such patients aren't candidates for the inlay if they've had cataract surgery.

The FDA does not recommend the Raindrop Near Vision Inlay for patients who:

  • Have severe dry eye or an active eye infection

  • Exhibit signs of corneal disease such as general thinning and a cone-shaped protusion in the center of the cornea

  • Have abnormal features of the outer part of the cornea to be implanted

  • Have certain autoimmune or connective tissue diseases

  • Lack enough cornea thickness to withstand the procedure

  • Have a recent herpes eye infection or problems resulting from a previous infection

  • Have uncontrolled glaucoma or uncontrolled diabetes

The agency determined that the Raindrop Near Vision Inlay was safe and effective based on a clinical trial of 373 patients who received the implant. After 2 years, 92% of the patients who figured into the final analysis had 20/40 vision or better at near distances.

The implant may cause or exacerbate problems with glare, halos, foreign body sensation and pain, according to the FDA. Recipients risk developing infection, inflammation, dry eye, retinal detachment, or a decrease in distance vision. Corneal complications such as scarring, swelling, clouding, or melting are other possibilities, as is epithelial ingrowth and the clouding that results. Some patients may need to have the inlay removed or replaced in a follow-up surgery.

More information on today's announcement is available on the FDA website.

 

Follow Robert Lowes on Twitter @LowesRobert .

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