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New Generation Lens Implants Instead of Bifocal Glasses AAO Media Update San Francisco, CA 2009 Barry S. Seibel MD Private Practice, Los Angeles and Beverly Hills, CA Clinical Assistant Professor of Ophthalmology UCLA David Geffen School of Medicine Financial Disclosure: Seibel Instruments from Rhein Medical and Storz Phacodynamics, SLACK, Inc. Consultant: Optimedica, Eyemaginations Medicare Standard; Prior Art Medically significant cataract: prevents glasses (or contacts) from giving sufficient vision for AODL Most patients need glasses for every distance (far and near/reading) A few have low enough astigmatism for POTENTIALLY good vision at one distance without glasses, usually far. Prior Art Option for “Bifocal Vision”: Monovision Only for patients with low astigmatism Good Luck with incision size, shape, location One eye for distance, One eye for near Successful only in a minority of contact lens patients Poor depth perception due to both eyes not focussing at the same place at the same time Next Step: Option of Astigmatism Reduction Allows much greater percentage of patients the option of either better distance vision without glasses, or monovision. Facilitated by new technology of corneal topography to map astigmatism for treatment by Limbal Astigmatic Keratotomies or LVC. Machine advances and Phacodynamics to reduce complications for ALL surgeries. Further facilitated by new developments in IOL biometry (e.g. partial coherence interferometry) for more predictability of eye power post-op Paradigm Shift: “Bifocal” IOLs Allow Both Eyes to focus at far and at near SIMULTANEOUSLY for more natural vision with depth perception Two basic designs: Diffractive / Refractive: light “bifocally” divided into distance and near focus Pseudoaccomodative: single focus optic designed to shift position in the eye with reading muscle effort Current FDA approved options ReSTOR: diffractive / refractive Crystalens: pseudoaccomodative Technis Multifocal: diffractive ReSTOR Initial version slightly too close a reading distance and sometimes inadequate intermediate (computer) vision Latest version good reading distance and intermediate for most patients Glare / Haloes inherent with multifocal design: mitigated some by apodization and diffractive/refractive design AcrySof ® IQ ReSTOR® IOL SN6AD3 Add Power: +4.0 D Spectacle Plane: +3.2 D Range: +10.0 D to +34.0 D A-Constant: 118.9 9 2 Overall Frequency of Spectacle Wear (Bilateral comparison) 100% 90% IQ ReSTOR® IOL +3.0 D [N=138] 80% IQ ReSTOR® IOL +4.0 D [N=131] 70% 60% 50% 40% 30% 20% 10% 0% Never Sometimes Always How often do you wear eyeglasses? 10 33 Source: AcrySof® IQ ReSTOR® IOL Package Insert Spectacle Freedom Overall Vision AcrySof® ReSTOR® IOL (N=339) 100 Array (N=99) 90 Eyeonics (N=128) 80 SA60AT (N=125) 80 69.3 69 % of Subjects 70 60 51 50 41 40 25.8 30 17 23 20 8 3 8 4.7 10 0 Never Sometimes Always Overall Spectacle Wear Comparativ e S&E data U.S. FDA Clinical Trials Summary of Results: 125 patients bilaterally implanted in U.S. • 94.6 % at one year would choose lens again. • 87% were 20/25 Near and 20/32 Distance simultaneously. • 94% were 20/32 (~J2) or better at near • 84.6% Reported never wearing glasses post surgery. *note: none of the patients studied had any form of astigmatic correction pre or post-cataract surgery. 12 Technis Multifocal Diffractive design Good distance and near ( ? too close ) Theoretically most glare of all 3 designs Theoretically most reading vision at more light levels than other designs Better Reading Speed At Near • For both dim (6 cd/m2) and bright (100 cd/m2) lighting conditions with no correction words/minute Hutz W, et al. J Cataract Refract Surg. 2006;32:2015-2021. 14 10 Package Insert of Tecnis Multifocal 15 Crystalens Pseudoaccommodative Initial design somewhat small optic and flexibility issues Current design larger optic with better stability Most patients with seamless range of vision from distance to intermediate or near/intermediate. Less glare than multifocal design Accommodative IOLs c m Q ui kTi e™ and a c G r aphi s decom pr ess or s c ar e nee ded t o see t h i pi t ur e. HumanOptics 1CU Eyeonics AT-45 Photopic Pupillometry and P-C IOL Design 1.2 ++ near / + dist +- near / ++ dist + near / ++ dist +- / 2.5 + nearint+ dist +- / + + near int dist ++int + near / ++ dist +- / ++dist 3.8 +-near int + int ++ near / + dist ++ + near /int ++ dist +- int + int ++ Personal Clinical Experience Matching right technology lens to right patient Extensive optional testing in biometry to achieve results not required when glasses are assumed most of the time post-op (insurance standard surgery) Extensive time evaluating patient goals and providing education about realistic function of various options, both before first eye AND before second eye Personal Clinical Experience ReSTOR for best chance of most range of vision (need bright light / smaller pupil for best near vision) Crystalens for good range of vision with less glare than multifocal designs; also in conditions not ideal for multifocals, including AMD, corneal non-clarity, etc. Technis Multifocal for best reading vision in widest range of lighting, including less bright conditions Future Options Soonest likely are more pseudoaccomodative designs Tetraflex similar to Crystalens Visiogen Synchrony uses unique dual optic design to theoretically give more accommodative amplitude (range of vision) than single optic designs such as Crystalens or Tetraflex. Currently larger incision size. Future Options Adjustable IOL power after implantation; Calhoun Vision Light Adjustable Lens Femtosecond Laser Assisted Cataract Surgery to further reduce complications and tighten refractive prediction outcomes Thank You!
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