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TECHNOLOGY WATCH Section Editor: John A. Vukich, MD New Accommodating IOLs Variable-focus accommodating IOL designs dominate the next wave of lens research. BY JOHN A. VUKICH, MD, SECTION EDITOR Welcome to the inaugural issue of Advanced Ocular Care! “Technology Watch” will be a regular column highlighting the innovations in ophthalmic surgery that shape the treatment of patients. The 5-year horizon for new techniques, technology, and equipment in this medical field is often visible in the results of early clinical trials and international experience. This column will feature experts from around the world who will share their insights into the latest developments. Some of the featured technologies may be available now; others may be several years from the market. Collectively, however, these innovations are the leading indicators of where ocular care is headed. In AOC’s coming issues, this column will cover laserassisted cataract extraction, glaucoma devices, and real-time aberrometry as well as other new technologies. I hope you find “Technology Watch” to be a valuable source of information on the innovations shaping the future of eye care. F ueled partly by the aging of the population and partly by advances in technology, research in accommodating lenses is leading the field of presbyopic correction. A number of accommodating IOLs are currently in use or under investigation. They fall into two general categories: (1) those with a mechanism that depends on forward movement of a single or dual optic and (2) those with a mechanism that depends on a change in the curvature of the lens’ surface. In addition, other factors are known to influence a patient’s near vision, and their effect is collectively referred to as pseudoaccommodation. Increased depth of field affected by pupillary size, low residual against-the-rule astigmatism, and higher-order aberrations (in particular, spherical aberration and coma) all can play a part in the IOL’s mechanism of action and influence the net effect of the restoration of functional near vision.1 THE MECHANISM OF NATURAL ACCOMMODATION An emmetropic eye is focused for distance when the ciliary muscle is relaxed. Resting tension on the zonular fibers extending between the ciliary body and the lens capsule pulls the natural lens into a flat, unaccommodated state. Contraction of the ciliary muscle occurs with near-focusing effort. When the ciliary muscle contracts, the ciliary body moves inward, releasing resting zonular tension. When the zonular tension relaxes, the elastic capsule surrounding the lens of a young eye molds the soft, deformable cortex and nucleus into a more spherical and accommodative form. This change decreases the lens’ diameter, increases its axial thickness, and, most importantly for the accommodative effect, steepens the curvature of the lens’ anterior and posterior surfaces.2-5 IOL S THAT MOVE IN THE Z AXIS Common to all accommodating IOL designs is the assumption that mechanical force generated by the ciliary body, vitreous pressure, or movement within the eye can be used to change the refractive power of the IOL. In the case of both single- and dual-optic designs, a change in the effective lens position is used to achieve an accommodative effect. Anterior movement of a plus-powered IOL changes the effective lens position, which results in a net gain in power. The higher the positive lens power is, the more net effect there will be for a given amount of movement. This is the theoretical basis for the mechanism of action for the single- as well as dual-optic accommodating IOLs.1 The only accommodating IOLs approved by the FDA are the Crystalens Five-O, Crystalens HD, and Crystalens AO (Bausch + Lomb, Rochester, NY). Other single-optic lenses with a potential accommodative effect include the Tetraflex (Lenstec, Inc., St. Petersburg, FL) and the Akkomodative 1CU (HumanOptics AG, Erlangen, Germany). Although all of these IOLs have been reported to have some beneficial near effect, their mechanism of action cannot be fully explained by a change in axial position.6-8 Clinical studies using a variety of measurement techniques have shown that lens movement is unreliable, small in amplitude (0.5 mm or less), and in some cases, opposite in direction.9 In order to explain the observed improvement in near vision experienced by some patients, alternate theories of action have been proposed, including optic deformation with increased spherical aberrations.1 Although their mechanism of action may not be fully understood, the initial commercial success of single-optic accommodating IOLs has generated substantial interest in the development of improved designs (Figures 1 to 3). The Synchrony dual-optic accommodating IOL (Abbott Medical Optics Inc., Santa Ana, CA) represents a novel design, which is intended to enhance the optical effect of the lens’ movement. The IOL has a 5.5-mm, 32.00 D front optic connected by spring haptics to a 6.0-mm posterior JANUARY/FEBRUARY 2010 ADVANCED OCULAR CARE 19 TECHNOLOGY WATCH Figure 2. The Tetraflex is designed to vault anteriorly in disaccommodation. In theory, dynamic forces within the eye during accommodation cause the optic to move anteriorly and increase net effective power. Figure 1. The Crystalens AT-45 was the first accommodating IOL to become available in the United States. The Crystalens Five-O (shown here) is designed to vault posteriorly in disaccommodation. In theory, greater vitreous pressure during accommodation causes the optic to move anteriorly and increase net effective power. optic of variable negative power. The single-piece silicone lens comes preloaded in an injector system and is inserted through a 3.6-mm incision. During resting disaccommodation, tension on the capsular bag compresses the optics together, storing energy in the connecting haptics. When the ciliary muscle contracts during accommodation, the zonules relax and release tension on the capsular bag. This change allows the spring-like energy of the compressed IOL to cause forward movement of the front optic. Thin lens optical calculations predict that 1.5 mm of movement by a 32.00 D anterior optic will result in 3.50 D of accommodation. An important feature of the Synchrony IOL’s design is that only the anterior 32.00 D lens moves, and because this is a fixed power, the amplitude of accommodation will be consistent across all lens sizes and will not vary among individuals. A study by Ossma et al reported a difference in mean accommodative range between eyes implanted with the Synchrony lens and control eyes that received a monofocal acrylic IOL (ie, Synchrony 3.22 ±0.88 D [range, 1.00-5.00 D] vs monofocal 1.65 ±0.58 D [range, 1.002.50 D]).10 The Synchrony lens has a three-dimensional structure, which fills the capsular bag and, when expanded, approximates the shape of the natural crystalline lens. It has been postulated that preserving the physiologic angle of attachment of the zonules to the capsular bag facilitates the translation of energy from ciliary movement.11 The expanded dualoptic IOL fully occupies the capsular bag, which may play a role in the low levels of posterior capsular opacification that have been observed.11 The lens received the CE Mark and has 20 ADVANCED OCULAR CARE JANUARY/FEBRUARY 2010 Figure 3. The Akkommodative 1CU is designed to have fourpoint fixation within the capsular bag. Its haptics are designed to facilitate anterior movement of the lens. been available commercially in Europe since January 2009. It is currently under review by the FDA (Figure 4). IOL S THAT CHANGE THE CURVATURE OF THE OPTIC Several lenses in the early stages of development are designed to change the optic’s radius of curvature upon accommodative effort. The NuLens (NuLens Ltd. Herzliya Pituah, Israel) is a sulcus-fixated accommodating IOL. This lens is designed to be implanted in front of the anterior and posterior lens capsules, which serve as a diaphragm that moves with accommodative effort. The transfer of force from the capsular diaphragm to the optic is accomplished via a piston element that is a part of the lens.12 In theory, the design specifications of the NuLens’ deformable optic could produce up to 10.00 D of accommodation.13 The NuLens has undergone preliminary human trials in Mexico. Currently, the IOL needs a large incision for implantation, but newer designs may reduce this requirement (Figure 5). TECHNOLOGY WATCH Figure 4. The Synchrony dual-optic IOL features a highpowered anterior optic and a negatively powered posterior optic that are separated by spring-like haptics. Figure 5. The sulcus-fixated NuLens is designed to rest on the collapsed anterior and posterior capsules. A piston mechanism drives fluid, which alters the radius of a deformable anterior membrane. properties of a young human eye. The current generation of single-optic IOLs will soon be joined by a dual-optic design that may provide more consistent results and thus broaden the use of accommodating lenses. Early prototypes of lenses with an even greater potential for accommodation are in various stages of development. One thing is certain: If investigators are able to develop an IOL that reliably provides 5.00 D of peak and 2.50 D of sustained accommodation, it will forever change the face of cataract and refractive surgery. ■ Figure 6. The FluidVision Lens uses a reservoir of liquid in its haptics to hydraulically alter the shape of the central optic. The FluidVision Lens (PowerVision Inc., Belmont, CA) moves fluid through channels from its soft haptics to a fluid-driven internal deformable membrane. This hydraulic action produces a controlled increase in the anterior curvature of the deformable optic’s anterior surface. Preliminary studies14 conducted in blind eyes have demonstrated an accommodative change of up to 8.00 D (Figure 6). Another shape-changing lens under development is HumanOptics’ Superior Accommodating IOL. This lens has a soft, gel-like internal nucleus surrounded by an elastic membrane designed to mimic the behavior of the youthful natural crystalline lens. CONCLUSION The correction of near vision can be improved by a variety of mechanisms that couple the mechanical forces of natural accommodation with an IOL designed to variably change its net optical power. The majority of research in new lens designs centers on developing an IOL that provides a smooth variable focus, thus mimicking the optical 22 ADVANCED OCULAR CARE JANUARY/FEBRUARY 2010 Section Editor John A. Vukich, MD, is a partner at Davis Duehr Dean Center for Refractive Surgery in Madison, Wisconsin. He has served as a consultant to Abbott Medical Optics Inc. as well as to other companies not mentioned herein with interests in accommodation, presbyopia, and accommodation-restoration concepts. Dr. Vukich may be reached at (608) 282-2000; [email protected]. 1. Glasser A.Restoration of accommodation:surgical options for correction of presbyopia.Clin Exp Optom.2008;91:279-295. 2. Glasser A,Campbell MCW.Biometric,optical and physical changes in the isolated human crystalline lens with age in relation to presbyopia.Vision Res.1999;39:1991-2015. 3. Weeber HA,Eckert G,Soergel F,et al.Dynamic mechanical properties of human lenses.Exp Eye Res.2005;80:425-434. 4. Glasser A,Kaufman PL.The mechanism of accommodation in primates.Ophthalmology.1999;106:863-872. 5. Rosales P,Wendt M,Marcos S,Glasser A.Changes in crystalline lens radii of curvature and lens tilt and decentration during dynamic accommodation in rhesus monkeys.J Vis.2008;8:18-22. 6. Harman FE,Maling S,Kampougeris G,et al.Comparing the 1CU accommodative,multifocal,and monofocal intraocular lenses:a randomized trial [published online ahead of print November 26,2007].Ophthalmology.2008;115(8):993-1001. 7. Brown D,Dougherty P,Gills JP,et al.Functional reading acuity and performance:comparison of 2 accommodating intraocular lenses.J Cataract Refract Surg.2009;35(10):1711-1714. 8. Sanders DR,Sanders ML.Visual performance results after Tetraflex accommodating intraocular lens implantation [published online ahead of print March 21,2007].Ophthalmology.2007;114(9):1679-1684. 9. Findl O,Leydolt C.Meta-analysis of accommodating intraocular lenses.J Cataract Refract Surg.2007;33:532-537. 10. Ossma IL,Galvis A,Vargas LG,et al.Synchrony dual-optic accommodating intraocular lens.Part 2:pilot clinical evaluation.J Cataract Refract Surg.2007;33:47-52. 11. McLeod SD,Vargas LG,Portney V,Ting A.Synchrony dual-optic accommodating intraocular lens.Part I:optical and biomechanical principles and design considerations.J Cataract Refract Surg.2007;33:37-46. 12. Ben-Nun J.The NuLens accommodating intraocular lens.Ophthalmol Clinic North Am.2006;19:129-134. 13. Alío JL,Ben-Nun J,Kaufman PL.Shape-changing IOLs:NuLens.In:Chang DF,ed.Mastering Refractive IOLs.The Art and Science.Thorofare,NJ:Slack,Inc.;2008:223-228. 14. Nichamin LD,Scholl JA.Shape-changing IOLs:PowerVision.In:Chang DF,ed.Mastering Refractive IOLs.The Art and Science.Thorofare,NJ:Slack,Inc.;2008:220-222.