Implant that changes shape of cornea approved by FDA

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The US Food and Drug Administration (FDA) has approved the Raindrop Near Vision Inlay, a device implanted into the cornea using a femtosecond laser to improve near vision in patients with presbyopia. It is the first FDA-approved implantable corneal device that changes the shape of the cornea to achieve improved vision.

Presbyopia is the loss of the ability to change the focusing power of the eye, resulting in diminished near vision. Bifocals and reading glasses are a common correction method, but corneal inlay surgery is an elective option for those who may not want to wear glasses.

The Raindrop Near Vision Inlay is a clear device made of a hydrogel material and resembles a tiny contact lens smaller than the eye of a needle. It is indicated for use in patients 41 to 65 years old who, in addition to not having had cataract surgery, are unable to focus clearly on near objects, but do not need glasses or contacts for clear distance vision. The Raindrop Near Vision Inlay device is manufactured by Revision Optics, based in California.

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.

‘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, deputy director for science and chief scientist in the FDA’s Centre for Devices and Radiological Health. ‘The Raindrop Near Vision Inlay provides a new option for surgical, outpatient treatment of presbyopia.’

Further information

Revision Optics