Eyeworld

87 EW FEATURE a small number taking up to 3 months. KAMRA patients might also struggle in low light situations, Dr. Durrie said. Raindrop The Raindrop, the latest to receive FDA approval in June 2016, is a hydrogel implant with a 32 µm central thickness placed under a LASIK flap at a depth of one-third corneal thickness, leaving at least 300 µm below the flap. The inlay steepens the optical zone to increase depth of focus. It is indicated for presbyopes with a manifest refrac- tive spherical equivalent of +1 D to –0.5 D with adequate distance vision but requiring +1.5 D to +2.5 D of reading vision. Like the KAMRA, the safety and efficacy of the Raindrop combined with LASIK or PRK is un- known, according to the company. Clinical trials showed this inlay can tolerate up to 0.7 mm of decen- tration in any direction, but Dr. Chu said he finds it more forgiving to inferior nasal placement and overall more forgiving to decentration than the KAMRA. During the surgery, Jeffrey Whitman, MD, Key-Whitman Eye Center, Dallas, noted that the femtosecond flap should be wetted with balanced salt solution every 20 seconds to ensure it doesn't dry out and develop striae. After the inlay is centered, has dried adequately (look for a dimpling effect like than of an orange peel), and the flap has been laid down, surgeons should expect a gutter opposite the hinge given a space-occupying implant under the flap. Dr. Whitman said this is nor- mal and will be gone the next day. "Don't play with it, don't irri- gate around it, don't think you can minimize it. Just stroke a few times when laying the flap down," Dr. Whitman said, noting that he does place a bandage contact lens for the patient's comfort. What Dr. Whitman thinks is nice about the Raindrop is its simi- larities to LASIK. "If I know how to do LASIK, I can do the Raindrop. I'm not learn- ing a new technique; I have lasers that can already make a LASIK flap, and I know how to work under a flap," he said. However, Dr. Chu cautioned against treating inlay patients like LASIK patients completely. "They need closer follow-up," Dr. Chu said, recommending these patients be followed closely for the long term. "Almost all of the complications that can happen from these inlays can be avoided if the patient is followed up earlier and treated appropriately before any- thing serious happens." Initial clinical trials for FDA approval revealed 92% of patients could see 20/40 or better at near 2 years postop. 5 Central corneal haze was listed as one of the most com- mon complications (16.6%), but it resolved in 89% of subjects. ReVision Optics is currently conducting further clinical studies on the use of the Raindrop inlay in pseudophakic patients as well as in a femtosecond laser-created pocket rather than under a flap. Flexivue Microlens This clear, corneal 3.2 mm inlay consists of a 1.6 mm central area with no refractive power and a pe- ripheral ring with a refractive power ranging from +1.5 D to 3.5 D. "The design of the inlay results in a multifocal effect that allows the patient to experience good near vision and distance vision," Edward Manche, MD, professor of ophthal- mology, Stanford University School of Medicine, Stanford, California, said of the implant currently in Phase 3 clinical trials. Dr. Manche said he places the hydrophilic acrylic inlay in a 300 µm femtosecond laser-created pock- et, using a custom mask provided by Presbia. This small temporal inci- sion is self-sealing, and Dr. Manche said the 5- to 10-minute procedure is "completely painless." Select- ing the right power for patients is determined based on their age and functional needs for near vision. While Dr. Manche said his pa- tients' experience with the inlay has been good, he noted a monovision contact lens trial helps determine the best power and patient toler- ance. According to a Presbia press announcement from May 2016, all continued on page 88 Highlights of EyeWorld's coverage of intracorneal inlays through the years February 2008 Corneal inlays: The next big thing? by Michelle Dalton "In the near future, surgeons will be able to add corneal inlays and scleral spacing procedures to laser options already offered as treatments for presbyopia." www.eyeworld.org/article-corneal- inlays--the-next-big-thing- June 2010 Intracorneal inlays may be preferred by Michelle Dalton "Although much has been written about the presbyopia-correcting IOLs, comparatively speaking very little has been published on alternative possibilities, such as corneal inlays or femtosecond laser treatments. Intracorneal inlays are considerably less invasive than either multifocal or accommodative IOL implantation and do not sacrifice distance vision to correct near, the experts say." www.eyeworld.org/article-intracorneal- inlays-may-be-preferred June 2011 Intracorneal inlays showing positive outcomes by Michelle Dalton "As the natural lens ages, its ability to accommodate begins to fail. The ability to return some of the near functions of our natural lens in its more youthful state or some semblance thereof is currently possible only through corneal or lenticular surgery. The options for presbyopia correction are LASIK (to create monovision), presby-LASIK, scleral segments, or premium IOLs. In the U.S., one other option, corneal inlays, is currently being investigated." www.eyeworld.org/article-intracorneal- inlays-showing-positive-outcomes February 2012 Clarity for KAMRA by Daniel S. Durrie, MD "The KAMRA corneal inlay by AcuFocus (Irvine, Calif.) is gaining traction as a great option for treating presbyopia in markets that have access to it, such as Europe, the Middle East, and Asia-Pacific. The inlay works based on the principle of small aperture optics and provides improved depth of focus to improve near vision while having minimal impact on distance vision." www.eyeworld.org/article-clarity-for-kamra March 2015 Correcting presbyopia: Monovision or corneal inlays? by Michelle Dalton "Surgical correction of presbyopia remains one of the Holy Grails of ophthalmology. Monovision correcting 1 eye for distance and the other for near is a fairly well understood concept. Today, the corneal inlay is fast approaching regulatory approval in the U.S., and understanding the advantages and disadvantages is integral to providing better patient outcomes, experts say." www.eyeworld.org/article-correcting- presbyopia--monovision-or-corneal- March 2016 The ins and outs of intracorneal inlays by Liz Hillman "Corrective options beyond readers include monovision LASIK, monovision contact lenses, and multifocal or accommodating IOLs, but some patients might not consider these attractive alternatives to readers." www.eyeworld.org/article-the-ins-and-outs- of-intracorneal-inlays March 2016 Managing patient expectations with corneal inlays by Ellen Stodola "Corneal inlays are a new technology to help improve vision in some patients with presbyopia. [Experts] discussed how to counsel patients with this new technology and other issues that must be addressed." www.eyeworld.org/article-managing-patient- expectations-with-corneal-inlays

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