EyeWorld Asia-Pacific June 2012 Issue

June 2012 33 EWAP CATARACT/IOL achieve spectacle independence. This is another level of achievement.” MPlus by Oculentis Billed as the “only presbyopia lens with HD-vision,” the MPlus by Oculentis has a sector shaped near- vision segment characterized by seamless transitions between near and far vision zones. “There is great visual acuity with the MPlus technology,” said Enrico Plessow , marketing management, Oculentis GmbH. “That’s mostly due to the small loss of light. We only have a loss of light of between 5-7%, which is much less than other technologies.” “It’s a more forgiving lens for surgeons to use, which is why it’s popular among them,” said Sheraz M. Daya, MD , Centre for Sight, London, England, UK. “In terms of the IOL, it’s a design where we’ve got a bifocal that acts like a bifocal in a spectacle frame. There are two focal points on the retina, and the brain tunes things in and out.” The problem with the MPlus, said Dr. Daya, is patients don’t always see well at near. In his experience, hyperopes are happier with the lens than myopes because myopes start off seeing well up close anyway. “Hyperopes can’t see well at distance or near,” he explained. “If they get [a lens] that gives them good distance vision and something more for near, they are very pleased. They don’t mind wearing glasses to read fine print. Myopes don’t forgive that.” The MPlus does cause glare during night driving in some patients, which they tend to describe as a triangle reflecting off a headlight and down onto the road. But Dr. Daya has developed a rather unique way around this problem. “I started putting the lens in upside down in patients, and that seemed to help with night vision,” said Dr. Daya. “They are able to drive because the glare is going upward now. They talk about [their vision] having a moon on top, but they are able to cope with that.” Dr. Daya implants the lens upside down in all patients now, and it has not negatively impacted the lens performance. “It’s a very good lens for ophthalmologists who are just starting out in the multifocal world,” he said. MPlus is CE marked and widely used across the world but is not approved by the FDA. According to Mr. Plessow, Oculentis has no plans to bring the MPlus to the U.S. “We’re trying to go to Canada and South America,” said Mr. Plessow. “It’s difficult for a small company to get licensed in the U.S. The American medical market is ruled by large companies, so the small ones don’t have a chance to get there.” PhysIOL’s FineVision The FineVision IOL is the first trifocal diffractive lens, providing patients with high-quality near, intermediate, and distance vision. It combines two diffractive structures that are adjusted to offer +3.5 D for near vision and another +1.75 D for intermediate vision. Like the MPlus, FineVision reduces the amount of light lost with most diffractive IOLs and uses that light for intermediate vision, while maintaining the performance for near and distance. Dr. Daya calls FineVision a “really good lens” and has implanted the IOL in just under 200 eyes. All patients, so far, are spectacle free. “It’s a lens where patients go ‘wow’ the next day,” he said. “I thought it would cause night vision troubles because it’s a trifocal, but the company was quite clever with how it designed the lens. It’s pupil dependent. The center point of the lens has more energy than near.” Although Dr. Daya’s patients are spectacle independent, Raphaël Ervinckx , global marketing manager, PhysIOL, cautions surgeons against overpromising. “We have a high rate of patients that are totally independent of spectacles,” he said, but surgeons still have to be careful when they consult with patients. “What we suggest [surgeons say is], ‘The majority of patients after FineVision don’t have glasses.’” Patient selection is important to lens success, said Dr. Daya. For example, a patient with more than 2 D of astigmatism may need PRK afterward. “If the astigmatism is with the rule, I can manage it,” he said. “If it is against the rule, I worry about [the patients] and tell them they have to have a two-phase operation. I’ll do the lens and PRK 6-12 weeks after to treat the residual astigmatism. They will see halos, but those get better with time.” A regular, symmetric cornea and pristine tear film and ocular surface are required. Any meibomian gland disease must be addressed first. FineVision was released in Belgium last year, and the lens already has 50% of the market share, said Mr. Ervinckx. The lens is CE marked, and PhysIOL hopes to expand the market into other areas soon. “For 2012, we’re considering two important markets: the U.S. and Japan,” said Mr. Ervinckx. “We are a small company, and we know it’s impossible to launch this lens in the U.S. because the FDA requires a lot of money. So in order to do this, our first goal in 2012 is to find a collaborator.” With the FDA climate affecting the innovation pipeline in the U.S., it’s quite possible none of these lenses will ever reach surgeons stateside. “The FDA has raised the bar in terms of what it will accept as proof if a lens really does accommodate,” said Dr. Dell. “Instead of just rigorous performance criteria, the FDA wants to see rigorous optical data that shows the light is being bent through wavefront analysis, with demonstrations of movement of the lens through imaging technology. It wants to see other evidence besides performance. So in some ways it is asking for data that is very difficult to obtain. “The FDA has the best intentions and the interests of our patients at heart,” he continued. “It doesn’t want to approve something that will hurt someone. But there has to be a balance between being overly cautious and shutting down the pipeline for approvals and protecting the public.” EWAP Editors’ note: Dr. Daya is an unpaid consultant for PhysIOL. Drs. Masket and Nichamin have financial interests with PowerVision. Contact information Daya: sdaya@centreforsight.com Dell: steven@dellmd.com Ervinckx: r.ervinckx@physiol.be Masket: avcweb@aol.com Nichamin: georgann@laureleye.com Plessow: enrico.plessow@oculentis.com Presbyopia-correcting - from page 31 Index to Advertisers Bausch + Lomb Page: 29, 32 Phone: +65-7834-9112 Fax: +65-6286-0448 www.bausch.com Carl Zeiss Meditec - Asia Page: 39 Phone: +65-6741-9600 Fax: +65-6842-7117 www.meditec.zeiss.com , www.zeiss.com.sg Moria Page: 15 Moria SA Phone: +33-(0)-1-4674-4674 Fax: +33-(0)-1-4674-4670 Email: moria@moria-int.com www.moria-surgical.com Moria in China Phone: +86-21-5258-5066 Fax: +86-2-5258-5067 www.moria-surgical.com.cn STAAR Surgical Page: 13 Phone: +65-6829-2146/+65-8100-7731 Email: atan@staarag.ch www.staar.com , www.visioninfo.com Technolas Singapore Pte Ltd Page: 24 Phone: +65-6592-0792 Fax: +65-6250-1060 Email: Y.Ng@technolaspv.com, M.Soon@technolaspv.com, A.Koh@technolaspv.com www.technolaspv.com, www.intracor.net Ziemer Ophthalmic Systems AG Page 52 Phone : +41 32 332 7122 Email : Sofia.Esposito@ziemergroup.com www.ziemergroup.com ASCRS Page 41 , 46, 51 www.ascrs.org APACRS Pag e 2, 35 www.apacrs.org