The Raindrop Near Vision Inlay Gets FDA Approval

Written by Dr. David Evans Last modified on August 6, 2018

There’s news in the world of corneal inlays with the recent FDA approval of the Raindrop Near Vision Inlay. (You can read the full FDA release here.) The Raindrop is just the second corneal inlay to get FDA approval; the KAMRA inlay being the first. If you’re already familiar with the KAMRA corneal inlay, then the Raindrop Near Vision Inlay might sound somewhat familiar, though the two devices certainly have their differences. We’ll probably do a comparison between Raindrop and KAMRA at some point, but for now I just want to focus on Raindrop.

Raindrop is From Revision Optics

For those who might not yet have heard of Raindrop, perhaps you’ve heard of its predecessors: PesbyLens and Vue+ (in Europe). Developed by Revision Optics, the Raindrop Near Vision Inlay is a microscopic hydrogel device (smaller than the eye of a needle) that is implanted into the non-dominant eye to treat presbyopia. It is indicated for people between the age of 41 and 65 who have good distance vision but have trouble reading things up close.

Revision claims that the hydrogel composition and optical characteristics of the inlay is the closest match to the human cornea. The minimally invasive outpatient procedure involves using a laser to cut a small flap in the cornea, placing the Raindrop inlay and then restoring the flap. Once in place, the inlay helps the non-dominant eye focus on near objects by changing the curvature of the cornea. The elective corneal inlay procedure is great for people who are looking to free themselves from reading glasses or multifocal contact lenses, but it’s not for everyone.

Are You a Candidate?

So what factors might affect your eligibility for the Raindrop Near Vision Inlay? If you’ve had cataract surgery you will not be a candidate for the inlay. The procedure is not recommended for people with chronic dry eye problems or those who suffer with corneal disease that can cause the cornea to be abnormally thin or cone-shaped (keratoconus). Other eye conditions such as infections or inflammation may be inhibitive as well. If you are interested in learning more about the Raindrop inlay and curious about your potential candidacy for treatment, the best thing to do is to schedule a consultation with an ophthalmologist.

The FDA Clinical Trial

The FDA approval of the Raindrop Near Vision Inlay comes after an extensive clinical trial in which 373 people implanted with the device were evaluated over the course of two years. Approximately 92 percent of those participating in the trial achieved 20/40 vision or better near vision. 20/40 is about the same size print as newspaper.

Side Effects and Risks are Rare

Although the Raindrop inlay does have the seal of approval from the FDA, there is the potential for certain side effects (as there is with just about any medical procedure). For example, some patients may experience issues with glare or halos in their vision, or experience the sensation of having something in their eye. Corneal scarring, swelling or clouding may also occur, in addition to the risk of diminished distance vision or even retinal detachment.

But don’t fret too much. The FDA approval signals that such risks and side effects are rare, and the procedure is considered extremely safe. Furthermore, the inlay is removable, meaning that if you do experience any issues after the procedure, you can opt to have it removed and simply resort to your reading glasses. (Although it should be noted that there is no guarantee that your vision will be exactly the same as it was prior to treatment after removal.)

We will continue to monitor the news related to the Raindrop Near Vision Inlay as it becomes more widely available throughout the U.S. The KAMRA inlay has taken the vision world by storm, even getting a recent shout out on Good Morning America, so it’s certainly a burgeoning market in near vision treatment.