BLOG: Approval of near vision inlay — A huge step forward
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The biggest news at ASCRS was the FDA’s approval of the AcuFocus Kamra inlay for correction of presbyopia. This is an enormous advance in patient care, bringing to the U.S. a technology that has been proven safe and effective extensively abroad. To date, more than 20,000 Kamra inlays have been implanted outside the U.S., AcuFocus said in September 2014. Another slightly different inlay technology, the Raindrop hydrogel inlay from ReVision Optics, has also been extensively used overseas, and together these two technologies are becoming a standard offering along with LASIK, PRK and lens-based surgery.
Corneal inlays are exciting because they treat the most challenging presbyopic patient, the young emmetrope. These patients occasionally do well with monovision, but many dread the loss of distance acuity that it requires. With near vision inlays, the device is implanted in the one nondominant eye, and uncorrected near vision generally improves to J1 or J2 while allowing preservation of distance at 20/20 or 20/25. Monovision simply can’t do that. Moreover, recent studies have shown that neither of these technologies significantly reduces contrast sensitivity — a requirement for making an emmetropic presbyope happy.
Lastly, this approval represents a major step forward for the FDA, which has made new approvals impossibly difficult, even for safe technologies that better patients’ lives.
I am particularly excited to see this technology become available and offer it to my own patients.
Disclosure: Hovanesian reports he is a consultant for ReVision Optics.