JAN 2012

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

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January 2012 Device focus INFINITI® System Indication: The INFINITI® System with OZil® Vision IP is indicated for emulsification and removal of cataracts, vitreous aspiration and cutting associated with anterior vitrectomy, and bipolar coagulation. Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician. Warnings: Appropriate use of INFINITI® Vision System parameters and accessories is important for successful procedures. Use of low vacuum limits, low flow rates, low bottle heights, high power settings, extended power usage, power usage during occlusion conditions (beeping tones), failure to sufficiently aspirate viscoelastic prior to using power, excessively tight incisions, and combinations of the above actions may result in significant temperature increases at incision site and inside the eye, and lead to severe thermal eye tissue damage. Adjusting aspiration rates or vacuum limits above the preset values, or lowering the IV pole below the preset values, may cause chamber shallowing or collapse which may result in patient injury. When filling handpiece test chamber, if stream of fluid is weak or absent, good fluidics response will be jeopardized. Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye. Ensure that tubings are not occluded or pinched during any phase of operation. The consumables used in conjunction with Alcon instrument products constitute a complete surgical system. Use of consumables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards. AEs/Complications: Use of the NeoSoniX® , OZil® or AquaLase® handpieces in the absence of irrigation flow and/ or in the presence of reduced or lost aspiration flow can cause excessive heating and potential thermal injury to adjacent eye tissues. Attention: Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions. torsional, U/S, Laser systems for refractive cataract surgery by Michelle Dalton EyeWorld Contributing Editor This month's column discusses the latest in "femto for phaco" T he latest phaco device in- novation to come to market or be in development is the advent of the femtosecond laser for refractive cataract surgery. Podium presentations have touted the ability of the lasers to cre- ate more precise incisions and cap- sulorhexis, but a hefty price tag and no long-term data (yet) have contin- ued the debate. With these devices estimated to cost anywhere from $400,000 to $550,000 and service fees after the first year expected to be about 10% of the purchase price, Jonathan H. Talamo, M.D., associate clinical professor of ophthalmology, Harvard Medical School, Boston, said rele- vant indications and regulatory ap- provals may be crucial for both manufacturers and those debating which system to purchase. Alcon's LenSx (Fort Worth, Texas) has regulatory clearance in the U.S. for capsulotomy, lens fragmentation, relaxing incisions, and cataract inci- sions. The LensAR system (Winter Park, Fla.) and Catalys (OptiMedica, Santa Clara, Calif.) have approval Contemplating continued from page 24 he may be facing a folded retina, Dr. Charles said. In his view, the issue comes down to being able to offer the pa- tient the best result. Dr. Charles feels strongly that as a retinal surgeon he shouldn't be doing elective cataract surgery and only reserves procedures such as phaco-vit for complicated retinal cases where the expectation of the patient isn't emmetropia with no residual refractive error. He pointed out that as a retinal surgeon he can't hope to achieve the same refractive outcomes as an anterior segment specialist. "If we're doing elective macular surgery where the outcome is expected to be 20/20, 20/25, or 20/30, we need to have the cataract surgeon do the cataract sur- gery at a separate setting under opti- mal conditions," he said. Conversely he believes that the same should apply to the cataract surgeon. © 2011 Novartis 12/11 INF546PI He emphasized the difficulty and complexity of vitreoretinal sur- gery and the need for proper train- ing. "So-called 'simple cases' can become intraoperative disasters with large retinal tears if inappropriate and all-too-common mistakes are made," he said. Dr. Charles thinks that anterior segment surgeons who perform pro- cedures such as pars plana vitrec- tomy may actually find themselves in precarious medical legal territory. "The basis for malpractice litigation is the standard of care," he said. Per- forming pars plana vitrectomy for anything other than very select cases such as the ones he mentioned does not conform to the current standard of care, he believes. He pointed out that the training period for retinal fellows is 2 years, and during that time he stays in the room while they are performing sur- gery to inspect their work and take over if needed. Overall, Dr. Charles thinks that the future of ophthalmology is in gaining expertise in specific areas. "Advances in medical outcomes have occurred not just because of better technology but because of in- creasing specialization," he said. As someone who has done over 29,000 vitreoretinal cases, he stressed that he follows this model. "I strongly practice what I preach and that is specialization," Dr. Charles said. EW Editors' note: Dr. Charles has financial interests with Alcon (Fort Worth, Texas). Dr. Packard has no financial interests related to this article. Contact information Charles: 901-767-4499, scharles@att.net Packard: 44-20-75801074, eyequack@vossnet.co.uk for capsulotomy and lens fragmenta- tion. Victus (Bausch + Lomb/ Technolas, Rochester, N.Y./Munich) does not yet have any U.S. regula- tory approvals. In Europe, Victus has received the CE mark for LASIK flap, astigmatic keratotomy, INTRACOR, capsulotomy, and lens fragmenta- tion. At the 2011 American Academy of Ophthalmology (AAO) meeting, William W. Culbertson, M.D., pro- fessor of ophthalmology, Bascom Palmer Eye Institute, Miami, said during a press conference on the topic that ultrasound energy use "was reduced by 45% in the laser pre-treated eyes compared with the eyes receiving standard phaco. Also, surgical manipulation of the eye was reduced by 45% in eyes that re- ceived laser pre-treatment as com- pared to manual standard surgery." As noted in Table 1, there are significant differences among the devices, namely in the areas of docking strategies, imaging, and ergonomics, Dr. Talamo said. Below, EyeWorld provides a brief synopsis of the lasers from various presentations (podium and other- wise) during the 2011 AAO meeting. Catalys Barry Seibel, M.D., Seibel Vision Surgery, Los Angeles, said compared with manual techniques, "we had a tenfold decrease in deviation from intended diameter" by using the Catalys. He presented results from a 29-patient study, where one eye was treated with the Catalys for capsulo- tomy and lens fragmentation and the other eye was treated manually. The system's liquid optics inter- face also allows for optimal lens pre- fragmentation, he said. "Because there is no corneal distortion, the in- traocular pressure rise is minimal," he said, which allows for "both pre- cise optical coherence tomography (OCT) imaging and accurate, pre- dictable, and energy-efficient laser delivery." LensAR Louis D. "Skip" Nichamin, M.D., Laurel Eye Clinic, Brookville, Pa., said a major benefit of the LensAR system is its "proprietary imaging; it's not OCT but 3D-confocal struc- tured illumination." Advantages to this type of imaging are its ability to provide a three-dimensional recon- struction of the anterior ocular structures through ray tracing while providing biometric data, including corneal, anterior chamber, and lens metrics, he said. continued on page 28

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