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Presbia Inc.) Corneal That Never Really Got Are Talking About Inducing Monovision Try to Improve Vision

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Presbia Inc.) Corneal That Never Really Got Are Talking About Inducing Monovision Try to Improve Vision 4 cover Story PRESBYOPIA PRESBYOPIA AND CORNEAL INLAYS Corneal inlays discover new lease of life as potential presbyopic treatment by Dermot McGrath he past few years have seen a Back to the future Given the current the inlays were eventually replaced by lasers resurgence of interest in corneal hype surrounding presbyopic inlays, it is which did the job more accurately,” he said. inlays as a potential treatment The Vue+/PresbyLens inlay (ReVision I think we need to perhaps easy to forget that the technology for presbyopia. Some surgeons has actually been around for a long time, optics Inc), currently undergoing clinical “keep an open mind have hailed the latest generation of inlay trials in the US, uses a refined version of this T said Daniel S Durrie MD, clinical professor and not rush to technologies as a breakthrough in the search of ophthalmology, University of Kansas approach, but changes the corneal curvature judgment on this for a universally effective and universally Medical Centre, and president, Durrie in the centre of the cornea only. promising technology applicable treatment for presbyopia. Vision, Kansas, US. The second type of inlay sought to change others warn that the marketing hype is “Corneal inlays for improving vision are the corneal power by putting a high index running ahead of the clinical reality and not a new concept. Back in the early 1980s refraction inlay in the cornea. José Güell MD that the inlay needs more hard data and we saw several different attempts at corneal “They ended up not being very permeable longer follow-up to assess its credentials as a inlays for the presbyopic market that never and the cornea biologically did not tolerate groundbreaking technology. really got off the ground for one reason or them very well, so that too was abandoned,” “I think we need to keep an open mind another,” Dr Durrie told EuroTimes. “What said Dr Durrie. and not rush to judgment on this promising we are seeing now is the maturing of this This approach has since been re-visited technology,” said José Guell MD, director technology, which addresses a lot of the by two inlays: the InVue corneal inlay Back in the early of the Cornea and Refractive Surgery Unit earlier issues with the inlays, and also more (originally developed by BioVision AG, later at the Instituto de Microcirugia ocular, acquired by neoptics AG) which addressed “1980s we saw several clinical data and commercial results are Barcelona, Spain. “We need more scientific the bio-compatibility issue by incorporating different attempts at starting to filter through, so we are seeing a data on both the safety and efficacy of new excitement about it,” he said. a pinhole in the centre of the lens that corneal inlays for the these inlays before we start recommending Dr Durrie identified three main types of allowed nutrients to pass through, and the presbyopic market them systematically to our patients. If we inlay that have been used over the years to Flexivue Microlens (Presbia Inc.) corneal that never really got are talking about inducing monovision try to improve vision. The first approach inlay which is placed in a self-sealing off the ground for one optionally in an otherwise healthy eye just tried to use inlays to change the corneal stromal pocket which holds the lens in place reason or another to slightly enhance near vision, then I don’t curvature, and in the process alter the in the centre of the visual axis. think the argument is strong enough to corneal power. propose that to my patients right now. But “A lot of these early attempts used Changing the optical principles Daniel S Durrie MD it could certainly be an interesting addition materials that were not very permeable to The third strategy to improve vision for to our surgical toolkit and merits close oxygen or glucose and were difficult to do presbyopes eschews changing either the attention as more data becomes available,” because everybody’s corneal curvature is power or the curvature of the cornea, but he said. different and it just wasn’t very accurate. So instead seeks to alter the optical principles The versatility of the “Kamra inlays makes them a great solution for presbyopia Gunther Grabner MD Courtesy of Gunther Grabner MD EUROTIMES | Volume 16 | Issue 11 “There has been a definite shift in the age profile of the typical refractive surgery 5 patient in recent years, from around 35 years about a decade ago to around 45 or 50 years-of-age today. These patients are looking for simple and effective solutions that can take care of their presbyopia, and I think corneal inlays will give us further options to offer more personalised solutions for these patients,” she said. Compared to approaches such as PresbyLASIK or IntraCor, corneal inlays offer a minimally invasive, safe, reversible Flexivue Micro-Lens Corneal Inlay (Presbia) surgical technique for presbyopes, said Dimitris I Bouzoukis MD, Institute of Vision and optics, University of Crete, Greece “There is no steep learning curve for the surgeon and the surgery can be performed without changing or adding new equipment or software in a modern refractive surgery theatre equipped with a femtosecond laser,” he said. Downsides to inlay technology But even the best technology has its IntraCor technique downsides – and corneal inlays are no Courtesy of Albou-Ganem MD exception. FLEXIVUE MICRO-LENS Inlay Characteristics: “The main disadvantage is that the inlay – Acts changing the refractive index of the cornea – Biocompatible hydrogel-based material with a central hole to increase more the nutrient flow. is a reasonable but not a perfect solution for – Donut shape bifocal refractive power presbyopia, as only one eye is corrected,” – The refractive effect is pupil depended, inreasing during – The lens is implanted into the stroma of the cornea on the said António Limão oliveira MD, Instituto non-dominant eye, inside a corneal tunnel created using near vision and decreasing during far vision, femtosecond laser. changing less the far vision in the operated eye than in a Microcirurgia ocular in Lisbon, Portugal, classic monovision procedure – The lens is “Invisible” who has been involved with the European The reversibility Courtesy of Dimitris I Bouzoukis MD multicentre trial of the Vue+ corneal inlay. “With this approach, binocularity “factor is certainly is disturbed, at least at near, and patients very attractive. If the of the cornea using small aperture optics. “The reversibility factor is certainly very become independent but not completely patient doesn’t like This is the approach favoured by the attractive. If the patient doesn’t like them, free of glasses for near vision,” he said. In them, they can be Dr oliveira’s view, the best candidates for Kamra inlay (previously the ACI 7000, they can be easily removed and no further easily removed and inlays are emmetropic presbyopes with a AcuFocus Inc.), which is leading the inlay procedure is required to restore them back no further procedure pack in terms of regulatory approval and to their original refractive status. I also clear lens, 20/20 uncorrected distance vision is required to restore clinical follow-up, with over 5,000 implants appreciate the fact that the inlays always and a near add of about +2.00 D. performed worldwide and four-year data enhance near vision, with only a marginal “The most important exclusion criteria them back to their from a Turkish centre now published1. loss of distance acuity depending on the for the Vue+ corneal inlay is dry eye, any original refractive “The versatility of the Kamra inlays makes inlay utilised. Because it is a monocular kind of corneal pathology, central corneal status them a great solution for presbyopia,” procedure, you always maintain quality thickness inferior to 500 microns, and monovision intolerance,” he said. said Gunther Grabner MD, professor distance vision in the other eye, which the Richard Lindstrom MD of ophthalmology and chairman of the patients seem to appreciate,” he said. Inlays may also be unsuitable for patients University Eye Clinic at Paracelsus Medical with very high expectations, said Dr University in Salzburg, Austria, noting Target market In Dr Lindstrom’s Bouzoukis. “As with all bifocal or multifocal that they have been implanted successfully view, the real target group for inlays are corrections, retinal image contrast may be in emmetropes, ametropes, monofocal not so much early-stage presbyopes that reduced in eyes implanted with the Flexivue pseudophakic patients and post-LASIK occasionally need reading glasses, but rather and Vue+ devices and retinal illuminance patients. the presbyopic population aged around may be markedly reduced with the Kamra There has been a “In the United States clinical study 50-upwards who have become handicapped implant. Effects on contrast sensitivity and stereopsis have yet to be adequately “definite shift in the of 507 patients who received the Kamra enough in their daily activities to consider inlay, 18-month data showed that the inlay alternatives to reading glasses. explored. Regarding reversibility and safety, age profile of the provided patients, on average, with J-2 While the initial expectation in the more studies are needed to demonstrate if typical refractive uncorrected near acuity, 20/25 uncorrected industry was that corneal inlays would hold the technique is really reversible with no surgery patient in changes to the preoperative emmetropic intermediate acuity and 20/20 uncorrected most appeal for emmetropic presbyopes, the recent years, from status of these patients, or if they are just distance acuity in their inlay implanted reality on the ground has been somewhat around 35 years eye. Additionally, for the Kamra inlay, the different, he said. removable, and to demonstrate that after a about a decade ago mechanism of action using small aperture “Emmetropic presbyopes are certainly long follow-up they are not creating corneal optics continues to work over several years candidates but the largest number of alterations,” he said.
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