EyeWorld India March 2012 Issue

March 2012 17 EW FEATURE Assoc. Prof CHEE Soon Phaik, MD Head & Senior Consultant, Cataract Surgery Service Singapore National Eye Centre 11 Third Hospital Avenue, Singapore 168751 Tel. no. +65-6227-7255 Fax no. +65-62277290 chee.soon.phaik@snec.com.sg I n Asia, countries such as India and Malaysia have ready access to the latest IOLs and phaco machines as there are no strict regulatory body guidelines for the import and use of medical devices in the country. In the past, Singapore used to enjoy similar privileges until the Health Science Authority of Singapore stepped in since August 2010 to regulate all medical products imported for use in the country. Now, it would typically take 8 months for a new medical device to receive approval for registration in Singapore. Prior to this, we were able to access new premium IOLs once they had a CE mark and thus enjoyed a wide range of multifocal, toric and combination IOLs. Currently, in the Singapore National Eye Centre where I practice, there are various multifocal IOLs to choose from such as the ReSTOR, AT LISA by Carl Zeiss Meditec and the Tecnis multifocal IOL by Abbott Medical Optics Inc. ( Santa Ana, Calif., USA). The optics of each of these lenses functions differently and thus when counseling patients for multifocal implants, possessing a good understanding of their optical performance is important. For example, both the ReSTOR and the multifocal Tecnis split light 50/50 between near and distance but the AT LISA is unique in that it splits light asymmetrically 65% for distance and 35% for near. The near add which determines the reading distance also varies. Having IOL options allows the surgeon to help the patient identify a best fit multifocal implant. Gaining access to the toric and multifocal toric implants soon after the multifocal IOLs allowed us to treat many of our patients with astigmatism by using a non-incisional lens-based technique, which enhanced the accuracy and predictability of our patient’s visual outcomes as compared with paired limbal relaxing incisions or cutting on the steep axis. Furthermore, having access to optical biometers such as the Carl Zeiss IOLMaster and Haag-Streit International Lenstar has greatly enhanced the accuracy of our refractive outcomes. Although new technology is often synonymous with better products, the doctor should always be mindful of the high cost attached, which invariably is passed on to the patient. Having ready access to new medical devices may not be attractive to many conservative ophthalmologists who prefer to adopt a watch-and-wait attitude. For instance, are all ophthalmologists convinced that a femtosecond laser will be able to enhance their cataract surgery outcomes? Jumping onto the band wagon may not be the wisest thing to do especially when the technology is yet in its infantile state, but high volume surgeons may be driven to joining their competitors for fear of being left behind. Editors’ note: Prof. Chee is a consultant for Technolas Perfect Vision (Munich, Germany) but has no financial interests related to her comments. YAO Ke, MD Chief and Professor, Eye Center Second Affiliated Hospital, School of Medicine, Zhejiang University No. 88 Jiefang Road, Hangzhou, China Tel. no. +86-571-87783897 Fax no. +86-571-87783897 xlren@zju.edu.cn W hile Europe and the United States are the two largest IOL markets, China looms as one of the fastest growing market for IOLs. As the baby boom generation enters their 60s, the demand for premium cataract procedures and products is increasing tremendously. Industry is driven largely by IOL demand. Alcon, Abbott, and Bausch + Lomb (Rochester, NY, USA) are undisputedly leading players in the Chinese IOL market. Chinese urban patients are especially willing to accept premium IOLs, because 80% of the cost of IOLs is covered by healthcare insurance. Since the former Chinese State Food and Drug Administration (SFDA) chief was sentenced to death for corruption and dereliction in 2007, the Chinese government has strengthened the approval and supervision of drug and medical devices. CE Mark classification depends on a set of rules and U.S. Food and Drug Administration (FDA) approval depends on other approved products’ equivalency. SFDA’s new regulations follow the FDA’s model. It may be easy to get certificate from SFDA if the product was approved by FDA, since the FDA provides elaborate preclinical data. The SFDA also identifies with CE Mark, but it tends to take a little longer to receive approval or failure possibly following CE Mark. In general, the total time is two years, at least eighteen months. Safety is paramount, but it seems to be a big lag behind our European counterparts. Alcon, the U.S.-based firm, also marks a crooked line for its new phakic IOL. Currently, U.S. surgeons have the choice of using two FDA-approved phakic IOLs: the foldable, collamer STAAR Visian ICL posterior lens (STAAR Surgical, Monrovia, Calif., USA/ Nidau, Switzerland) or the non-foldable Verisyse from Abbott Medical Optics. Though Alcon’s Cachet has won praise in Europe and Canada with 10-year data available to demonstrate its safety and efficacy, it is still outside the U.S. and is currently in an FDA trial. In China, the Cachet IOL received SFDA approval two years ago and is now carefully applied in small limited areas to cater to the thousands for testing demanded by the FDA. Chinese cataract surgeons are in a dilemma. We are interested in premium IOLs and are familiar with our counterparts’ impressions and experience but have to wait for a long process for SFDA approval. On the other hand, native IOL manufacturers lack new technology and innovation because of late start and insufficient input. Chinese enterprises are keenly aiming at profitable and popular products such as cars and electronic goods. We would like to see future development and the use of premium ophthalmic devices under safe and effective systems and share our experiences with global ophthalmologists. Editors’ note: Prof. Yao has no financial interests related to his comments. Views from Asia-Pacific USA/Hünenberg, Switzerland], but they don’t know anything in the States about the bifocal concept and they are wondering what kind of results we’re getting,” Dr. Mertens said. According to a story published last year in EyeWorld , with the MPlus, an “aspheric, asymmetric far-vision zone is combined with a sector-shaped near-vision zone of +3 D allowing for seamless transition between the far and near vision zones.” Dr. Packer said the MPlus offers a “wow factor” that interests him. “As someone who is interested in optics, I look at that design in amazement and say, ‘No way!’ That can’t be possible, and yet friends of mine, colleagues whom I completely trust, say they have good results with it. The patients do not get dysphotopsia or unwanted scotomas. It’s something I would certainly like to try.” The FineVision lens offers patients a full range of multifocality, but does not compromise their intermediate vision, said Damien Gatinel, MD , professor and head, Anterior Segment and Refractive Surgery Department, Rothschild Ophthalmology Foundation, Paris, France, who helped consult on the continued on page 18