Eyeworld

EW CORNEA 116 March 2018 is someone with a healthy cornea, good tear film, and positive attitude. "You need to make sure that there is no sign of Salzmann's nod- ules, rosacea, or other pro-inflam- matory/fibrotic pathologies, which might create problematic long-term haze or fibrosis in the stroma," said Dr. Lobanoff, who has implanted the Raindrop. "The tear film is criti- cal as you are going to purposely al- ter the anterior corneal topography in a way that subtly makes it harder for the tear film to evenly cover the epithelium. Finally, a good, 'can do' attitude makes it easier for a patient to adjust to a new visual system." Jeffrey Whitman, MD, Key-Whitman Eye Center, Dallas, who also offered the Raindrop after being part of its FDA clinical trials, said if the patient's eyes are healthy enough for LASIK—Raindrop re- quires a LASIK-like flap—they could be a candidate for this inlay. Dr. Whitman also said he tries to identify patients who might not be able to adapt to this type of vision. "Unlike LASIK where both eyes are going for distance vision, when you put the inlay in, you're going to decrease the distance vision slightly in the treated eye. Is the patient an easy-going person or are they an obsessive compulsive, engineer- ing-type patient?" Dr. Whitman said. "The important thing about doing surgery like this is being realistic. It's not going to make their eyes like they're 21 again, and even with this, they may need readers from time to time. Their eyes are not going to see evenly at distance like they may have before. I try to paint the downsides with broader strokes and if they spook … I would say this isn't a treatment for you." Dr. Whitman and Dr. Lobanoff said they initially performed contact lens trials for inlay candidates preop but have since abandoned this practice. Dr. Whitman found pa- tients focused on the fit and feel of the contacts rather than the visual experience. If a physician did want to provide a trial, Dr. Whitman recommended having patients wear contact lenses in the office. If they tolerate that, it's a positive test. Dr. Wiley does simulation test- ing on every inlay patient. Raindrop and Flexivue lend themselves well to a multifocal contact lens trial, he said, while KAMRA can be simulated in the lane with a pinhole trial. The procedure and combined laser ablation All three doctors said corneal inlays lend themselves well to combined laser procedures. "We think it's essential; don't be hesitant to talk about [treating] the dominant eye because the dominant eye is going to be the key for excellent distance vision," Dr. Whitman said. "If it's even a quarter or half a diopter off emmetropia, it means LASIK treat- ment. Patients understand there's an expense for that, but they also understand … the point that their distance vision won't be quite as good in the other eye, and this is why we need to do it." Dr. Whitman targets +0.25–0.5 D in the inlay eye and emmetropia in the dominant eye. Combining inlays with laser ablation, Dr. Lobanoff said, expands the pool of patients who can benefit from this technology. "For the past year I have been combining excimer treatment with the inlays and have seen better results. Even small amounts of astigmatism that may be acceptable per the FDA study will affect image quality and can be the difference between a happy and unhappy patient," Dr. Lobanoff said, adding that he targets plano sphere. For the Raindrop procedure, Dr. Whitman makes a LASIK flap, performs LASIK treatment (if neces- sary), applies mitomycin-C (MMC) for 30 seconds, and places the inlay, letting it dry slightly, before putting the flap back in place. KAMRA and Flexivue, on the other hand, are placed within a pocket. Dr. Wiley said there is a slight learning curve for working in the pocket, but with the KAMRA especially, alignment is key. Dr. Whitman said he began using off-label MMC after reports showed reduced fibrosis/haze. Though haze was rare in the clinical trials, Dr. Whitman said reducing that to the lowest possible percent- age is the goal. "We get very clear interfaces; it's rare to see inflamma- tory fibrosis anymore," Dr. Whit- man said. Dr. Lobanoff and Dr. Wiley use MMC as well. "I use mitomycin-C with all of my inlays, but my part- ner is not currently using it with the aperture inlay and our results are similar. I think it's less important with the aperture inlay and more important with the shape-changing inlay," Dr. Wiley said, explaining that Raindrop is implanted at a shal- lower depth, compared to KAMRA and the Flexivue Microlens, where the cornea can be less tolerant to a foreign body. Postop situations If patients are doing well after the first 2 months, Dr. Lobanoff will follow them at 3-month intervals, counseling them carefully on when to call if they experience photosen- sitivity or changes in vision or their ability to focus at distance or near. Likewise, if patients are doing well 3 months postop, Dr. Whit- man will begin seeing them every 6 months. "The reason is because in some studies delayed fibrosis was seen in some patients. We think that may be gone now that we're using MMC, but it hasn't been long enough to know that yet," he said. Dr. Wiley sees patients regularly within the first 6 months, mostly to monitor their ocular surface, treat- ing any issues that arise. After that, he'll see patients on a yearly basis. If a patient does develop haze/ fibrosis, Dr. Whitman starts with a stronger steroid tapered to a lower steroid over a 2- to 3-month period. He will treat haze three times with steroid drops before recommending explant of the inlay. "To me, that says that some- thing is different about this patient's immune system, and leaving it in there makes no sense and could lead to proliferative fibrosis that could cause scarring; we don't want that," Dr. Whitman said. Dr. Lobanoff follows the same "three strike rule." If a patient doesn't adapt well to the inlay, one of the benefits of these implants is they can be explanted with little to no negative effect on the patient's prior vision. If you're interested in offering inlays, Dr. Whitman said speaking with someone at one of the compa- nies or observing surgery are good starting points. "A visitation and watching surgeons do it is hard to replace. You ask questions you wouldn't think about and you get unsolicited opinions about what's going on that maybe someone never wrote down," Dr. Whitman said. Dr. Lobanoff reemphasized careful patient selection, aggressive pre- and postoperative dry eye ther- apy, and aggressive inflammation treatment for longer than you might think necessary. Coming down the pipeline As for future inlay technologies coming to the market, Flexivue has already received the CE mark in Europe and is currently in Phase 3 clinical trials in the U.S. Dr. Wiley said ideally, U.S. surgeons would be familiar with all available inlays, offering them to patients based on their specific indications and visual needs. The KAMRA, he said, is a great add-on option for presbyopic patients seeking out laser refractive surgery. The Raindrop, Dr. Wiley continued, when it was available, is suited for plano to low hyperope patients with vision analogous to that of monovision. Dr. Wiley said he thinks the Flexivue will bring in near vision without epithelial remodeling. In theory, you could adjust the near vision target of the Flexivue based on patients' needs. Another inlay of interest is the PrEsbyopic Allogenic Refractive Lenticule (PEARL), which involves fashioning a small allogenic inlay from the lenticule removed in small incision lenticule extraction. Dr. Lobanoff said this is an interesting concept but needs more devel- opment. "Theoretically, it should function optically much like the Raindrop inlay. However, I think preparation of a perfect lenticule may prove difficult," he said. As for allogenic inlays made from donor tissue, Dr. Whitman said questions remain about the inflam- matory response of the inlay recipi- ent to the donor tissue inlay. EW Editors' note: Dr. Lobanoff has finan- cial interests with Alcon (Fort Worth, Texas). Dr. Wiley has financial inter- ests with AcuFocus and Presbia. Dr. Whitman has no financial interests re- lated to his comments. The physicians were interviewed prior to ReVision Optics going out of business, thus their comments reflected their opinions and use of the Raindrop inlay at that time. Dr. Whitman told EyeWorld after the fact that he will continue to provide the Raindrop inlay to his patients, as he still has a good stock of them. In general, he said that he hasn't been as impressed by other technologies enough to change to another inlay at this point but added that he is open to seeing what the future holds. Dr. Lobanoff shared with EyeWorld after the fact that surgeons have learned a "tremen- dous amount from the Raindrop surgi- cal experience" and future intracorneal inlays will build upon this knowledge base. Dr. Lobanoff added he will use many of the surgical techniques and pearls he learned from ReVision Optics to "[make] the next generation of inlays safer and more effective for patients." Contact information Lobanoff: mlobanoff@gmail.com Whitman: whitman@keywhitman.com Wiley: wiley@cle2020.com Intracorneal continued from page 114

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