Intracorneal Inlays for Presbyopia

Hawaiian Eye 2014

Roger F. Steinert, MD


February 18, 2014

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Hi. This is Dr. Roger Steinert, Chair of Ophthalmology and Director of the Gavin Herbert Eye Institute at the University of California, Irvine. It is the last day of the Hawaiian Eye meeting in Kauai, Hawaii. The subject this morning for the comprehensive ophthalmologist is refractive surgery. I would like to discuss my own presentation of Revision Optics Raindrop® (Revision Optics; Alta Vista, California) hydrogel inlay.

There has been a fair amount of publicity about the AcuFocus [KAMRA™] pinhole inlay, which we all hope will receive US Food and Drug Administration (FDA) approval this spring or early summer. That works through the basic optics of a pinhole aperture with this inlay centered on the pupil to correct presbyopia in 1 eye. The Raindrop is the second of 3 ways that intracorneal inlays have been proposed to correct presbyopia. The third method is the Presbia inlay [Flexivue Microlens™], which has a higher index of refraction and somewhat donut-shaped optic and is set deep in the cornea.

The Revision Optics Raindrop (and I am the FDA medical monitor for that) is a 2-mm hydrogel, a very thin disc, no thicker (depending on the power) than approximately 30 µm. It is placed typically under a flap (perhaps in the future it will be placed under a tunnel) at a depth of about 160 µm. This results in what has been called a pro-focal shape to the anterior cornea. It steepens the central cornea but, after epithelial remodeling, lends a shape change that is truly multifocal. It does this in a way that doesn't carry a lot of the negativity that has been present in attempts to create this kind of a shape with a laser on the front of the cornea because it is additive, whereas a laser procedure is inherently subtractive, which produces remodeling results that are unstable and often unsatisfactory.

The remarkable finding in the Revision Raindrop FDA trials so far -- and they are in phase 3 here in the United States -- has been that there is typically, on the average, only about 1 line loss of distance vision, so this is not monofocality. It is very different. At the expense of that loss of 1 line of distance vision, the average patient, on the average, gets J-2 near vision and also gets intermediate vision. Patient satisfaction has been extraordinary.

With inlays, there are always issues of foreign-body reaction, haze, and explants, but there have been remarkably few. There was a very well worked-out protocol for having a very high rate of tolerance of these devices. They have been in corneas now for many years and have a very high tolerance. This is largely due to the fact that the high water content hydrogel allows glucose, ions, and other nutrients to pass right through, and it's very small, so nutrients can also pass around the inlay, making the corneal tolerance of the inlay very high.

Patient satisfaction is very high. In fact, in studies going on outside the United States, patients are having such a good result in the first eye that they are asking for it in the second eye. They are not losing that much distance vision, and they are very happy with the reading vision.

This is something that you are going to want to keep a watch on as we go forward as yet another possible solution to presbyopia.

This is Roger Steinert, on behalf of Medscape. Thank you very much for listening.


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