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ThinOptX IOL is now available in Europe
The rollable lens makes it possible to perform cataract surgery through a 1.4-mm incision.
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ATHENS, Greece – The ThinOptX IOL, a rollable lens that can be inserted through an incision of less than 2 mm, is now available in Europe. The ThinOptX IOL received CE Mark approval in September, allowing the lens to be officially marketed throughout Europe, the company announced during the European Society of Cataract and Refractive Surgeons in Nice, France. The news of the IOL’s recent approval took ESCRS attendees by storm.
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The lens will make microincision surgery a reality in Europe, said John A. Kanellopoulos, MD, who practices here and in the United States. He is an associate professor of ophthalmology at New York University Medical School.
Dr. Kanellopoulos said the thickest part of the lens is only 350 µm, making minimum-incision cataract surgery possible.
“We showed for the first time in 1999 that sub-2-mm surgery and IOL implantation is possible using the Nd:YAG photolysis device, and now with the phaco technology adapting to the extremely small incision, we are able to complete a cataract procedure with phaco through incisions smaller than 1.5 mm,” he said.
Dr. Kanellopoulos said the lens complements existing phaco instrumentation that is capable of operating through a microincision.
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“[Before], our hands were tied because we did not have the technology in intraocular lenses to match our ability to perform the surgery through incisions smaller than 2 mm,” Dr. Kanellopoulos said.
His practice in Greece was one of the first to use the lens and assist ThinOptX in its development, he said. Clinical trials of the lens will be started in the United States in the near future, he added.
“I am very excited about this news because now everyone in Europe will have the advantage of working through sub-2-mm incisions for cataract surgery,” Jorge Alió, MD, PhD, told Ocular Surgery News. Dr. Alió, in practice in Alicante, Spain, has been largely involved in the European trials for ThinOptX, and he has been very pleased with the results.
According to ThinOptX, the IOL’s marketer, this IOL is the first “thin lens” approved for clinical use and it can retain the optical quality of popular, thicker IOLs while rolling through a minimal incision.
Revolutionary design
The design of the lens is different from that of other lenses now available, Dr. Kanellopoulos said.
“The ThinOptX lens has an escalated perimeter that allows it to be ultrathin without compromising extreme lenticular powers on the plus and minus side,” he said.
As a result, the thickest part of the lens is 350 µm, and the haptic part of the lens is as thin as 50 µm, he said. The one-piece lens is made of hydrophilic acrylic material.
“This design is quite revolutionary, because it allows rolling of the lens and fit of the rolled lens through ultrasmall incisions,” he continued.
In comparison, other hydrophilic acrylic lenses have a central thickness between 1 mm and 1.2 mm, depending on the power, Dr. Kanellopoulos said. Some high-power lenses can be as thick as 1.5 mm, he said.
Dr. Kanellopoulos said the lens has been erroneously compared to multifocal lenses and Fresnel prisms.
“This is not a technology that is similar to those. It has a unique design. We are looking at contrast sensitivity in addition to visual acuity and all of the standard measurements, and we are not finding any significant compromise with the use of this specific lens. We consider this a major advantage,” he said.
In a pilot study, Dr. Kanellopoulos implanted the lens in 10 eyes. To date, he has monitored the patients for 3 months and will conclude the study at 6 months. He has had excellent preliminary results, but noted that a larger, more collaborative study is necessary to evaluate the lens’ safety and efficacy.
Although he said he plans to incorporate the lens into his regular practice after 6-month follow-up of the pilot study, he also plans to conduct a larger study of the lens in the United States.
“We’re going to compare energy use, as well as all the other parameters of cataract surgery, such as visual acuity, intraocular pressure and contrast sensitivity using phaco, laser phaco and the ThinOptX lens,” he said.
ThinOptX, phaco technology
Dr. Kanellopoulos uses the lens with the AMO Sovereign phacoemulsifier with WhiteStar technology. With the WhiteStar upgrade, he said, the Sovereign uses only about a quarter of the power emitted by the standard Sovereign. He said he chose the WhiteStar system because the temperature of the phaco tip stays cool.
“The Sovereign uses a cooling sleeve around the phaco needle. The WhiteStar upgrade allows the phaco power to be fed into the phaco tip in such a way that does not raise its temperature. … Because of the WhiteStar upgrade, we were able to dissociate the phaco tip from the irrigation, which is performed through a separate [incision] of the same size,” he said.
He inserts the ThinOptX lens through a 1.4-mm incision using an injector specifically created for it by Geuder. The entire cataract procedure is done bimanually through two incisions.
“According to U.S. studies by Olsen and Donnenfeld this year, if you isolate the phaco tip from the irrigation tip, the temperature at the incision site within the cornea does not rise above 86° F — far below the normal temperature of the body. Using the WhiteStar technology, you can perform ultrasmall-incision surgery without any compromise of the clear corneal wound. The ThinOptX technology complements the use of such cataract instrumentation and fulfills the procedure under the same incision size,” he said.
For Dr. Kanellopoulos, the approval of the ThinOptX lens is the culmination of his team’s efforts in developing the phaco technology that has emerged for minimum-incision cataract surgery.
“This is a remarkable pioneering effort for our dream of the future — to perform true endocapsular cataract surgery and complete the procedure through minute incisions, preserving all of the capsular bag and presumably preserving accommodation as well. We see this as an important step in the process of achieving that goal,” he said.
For Your Information:
- John A. Kanellopoulos, MD, can be reached at the Ophthalmologic Institute, Pirgos Athinon, Mesogeion 2 and Vasilissis Sofias, Ampelokipoi, 11527 Greece; +(30) 10-747-2777; fax: +(30) 10-747-2789; or at 115 E. 61st St., Suite 1B, New York, NY 10021 U.S.A.; +(1) 212-355-2215; fax: +(1) 212-758-3532; e-mail: laservision@internet.gr; Web site: www.laservision.gr. Dr. Kanellopoulos has no direct financial interest in the products mentioned in this article, nor is he a paid consultant for any company mentioned.
- Jorge L. Alió, MD, PhD, can be reached at Inst. Oftalmologico de Alicante, Avda Denia 111, 03015 Alicante, Spain; +(34) 695-150-025; fax: +(34) 96-515-1501; e-mail: jlalio@oftalio.com. Ocular Surgery News could not confirm whether Dr. Alió has any financial interest in the products mentioned in this article, or if he is a paid consultant for any company mentioned.
- ThinOptX, manufacturer of the ThinOptX IOL, can be reached at P.O. Box 784, Abingdon, VA 24212 U.S.A.; +(1) 276-623-2258; fax: +(1) 276-623-5661; e-mail: thinoptx@naxs.net; Web site: www.thinoptx.com.
- Advanced Medical Optics, manufacturer of WhiteStar Technology for the Sovereign System, can be reached at 1700 E. Saint Andrews Place, Santa Ana, CA 92799 U.S.A.; +(1) 714-247-8200; fax: +(1) 866-872-5635; Web site: www.amo-inc.com.