Mark Packer, MD, FACS
Emmetropia and full accommodation remain the goal of refractive cataract and lens surgery. Already we’ve witnessed dramatic advances in the field, from a time only 10 years ago when only a single zonal refractive multifocal IOL was available in the United States to today’s array of FDA-approved refractive and diffractive multifocal and single optic accommodative designs.
Since May 2005, the Center for Medicare and Medicaid Services (CMS) has allowed beneficiaries to pay out-of-pocket for services associated with the implantation of presbyopia-correcting intraocular lenses to reduce or eliminate the need for glasses after cataract surgery. In 2005, there were 3 entries in this category: the crystalens, a single optic accommodative lens subsequently acquired by Bausch & Lomb (San Dimas, CA); the ReZoom, a refractive multifocal IOL from AMO (now Abbott Medical Optics, Santa Ana, CA); and the ReSTOR, a diffractive multifocal IOL from Alcon (Fort Worth, TX). In the past 4 years both the crystalens and the ReSTOR have undergone major makeovers, and AMO has launched an entirely new multifocal, the aspheric diffractive Tecnis Multifocal IOL. In addition, we now have available toric IOLs from both STAAR Surgical (Monrovia, CA) and Alcon.
The TetraFlex
The TetraFlex IOL (model KH-3500; Lenstec, St. Petersburg, FL) is a single piece acrylic lens with a 5.75-mm, square-edged, biconvex lens optic. The haptics have a unique design that mimics a perforated plate haptic appearance. It is foldable and can be inserted through a 1.8-mm cartridge. The lens is designed to assume an anterior flexed position in the capsular bag and to move anteriorly with ciliary body contraction.
Sanders reported on a series of 95 eyes of 59 patient customers implanted with the Tetraflex lens, including 36 implanted bilaterally. At 6 months after surgery, 63% of all cases achieved a DCNVA of 20/40 or better. Virtually all had at least 1 diopter (D) of accommodative amplitude (98% at 1 month; 100% at 3 and 6 months); 75.7% had at least 2 D at 6 months after surgery. At 6 months or later, 92.2% had 20/40 or better UCDVA. The proportion of cases achieving a UCNVA of 20/40 or better remained relatively constant at 45% to 47%. At 6 months and later, 98.7% had a BCDVA of 20/40 or better. In the bilaterally implanted series, at 1 month after surgery, all had at least 1 D of accommodative ability; 96% had at least 2 D at 6 months. One hundred percent achieved a BCDVA, 89.3% achieved a DCNVA, and 74.1% achieved a UCNVA of 20/40 or better at 6 months after surgery. The authors concluded that the Tetraflex accommodating IOL provides enhanced near vision with good distance vision 6 months after surgery.1
The Synchrony
In San Francisco at the recent American Academy of Ophthalmology meeting, the news on everyone’s lips was the acquisition of Visiogen, Inc., by Abbott Labs. Visiogen is a small, privately funded company with one product, the accommodative intraocular lens christened “Synchrony.” The lens is not yet approved for sale in the United States; a response is expected from the FDA this year.
The Synchrony promises to deliver a percentage of spectacle independence closer to that of the Tecnis and ReSTOR without the loss of contrast sensitivity and unwanted optical side effects like halos around lights at night that are part and parcel of multifocal IOL technology. A large body of data from experience outside the United States has demonstrated that the Synchrony may offer a successful alternative here as well (see xxx). In addition, the Synchrony features a preloaded injector that delivers the dual optic implant through a 3.8-mm clear corneal incision.
http://www.visiogen.com/international/VisiogenESCRSarticles.pdf
Imaging studies have demonstrated movement of the anterior optic of the Synchrony, corresponding to the clinical amplitude of accommodation. In their retrospective analysis of 5 Synchrony patient customers, DCNVA ranged from 0.0 to 0.20 logMAR (20/20 to 20/32 Snellen acuity), push-down accommodative amplitude ranged from 2.76 to 3.22 D and defocus curve accommodative amplitude ranged from 1.50 to 2.75 D. Objectively, UBM confirmed axial forward movement of the front optic, while iTrace showed dynamic power change in refraction.2
The Synchrony IOL is a new alternative for presbyopia correction in the setting of cataract surgery and in the field of Refractive Lens Exchange. Refractive Lens Exchange is increasingly seen as an advantage over cornea-based refractive procedures, especially in those over 45.3 The function of the dual optic offers the opportunity to achieve accommodative amplitude of 3 D to 4 D by virtue of its increasing power. To optimize surgical outcomes with the dual optic IOL design (as with any other new IOL technology), we emphasize the importance of careful patient customer selection, adequate and consistent biometry method for accurate power calculation, and the implementation of a consistent surgical technique: CCC size and shape, complete cortical clean-up, anterior capsule polishing, in-the-bag IOL implantation, and rigorous postoperative regimen. Further large-number studies with longer follow-up are necessary for final estimation. These data will be available following FDA evaluation of the US multicenter clinical investigation of the Synchrony, expected during 2010.
The Sulcoflex
When it comes to the correction of astigmatism, in the United States, outside of Investigational Device Exemption (IDE) clinical investigations, we are limited to FDA-approved devices, which at present include only the STAAR 4203 TF and 4203 TL in 2.0 and 3.5 D powers, the Alcon SN60T3/4/5 in 1.5, 2.0, and 2.5 D powers. Manufacturers outside of the United States who have heeded the call to provide toric solutions include Rayner (Hove, UK), which manufacturers the T-flex 573T/623T from 1.0 to 11.0 D in 0.25 D steps. HumanOptics (Torica-S, Erlangen, Germany) and Zeiss (Acri.Comfort 643TLC/646TLC, Jena, Germany) also offer an expanded range of powers in toric IOLs.
Rayner introduced its C-flex platform in the United States this year (Figure 1) and also has an intriguing line of supplementary sulcus IOLs for pseudophakic patient customers, the Sulcoflex, designed for implantation in the ciliary sulcus of pseudophakic eyes as a piggyback lens. These are single-piece hydrophilic acrylic IOLs which can be inserted through a 3-mm incision. The 6.5-mm optic and haptic edges are round. The haptic is angulated and has an undulated design to preclude rotation. A spherical, monofocal version of the Sulcoflex has been implanted in the ciliary sulcus of pseudophakic eyes in order to correct residual ametropia. Toric, multifocal, and aspheric versions of the lens are also available to correct residual astigmatism, permit presbyopia correction, and reduce higher order aberrations in pseudophakic eyes.4 The availability of these implants in the United States could significantly enlarge the potential pool of premium IOL customers by making available presbyopia and astigmatism correction for those with pseudophakic eyes.
FluidVision
Further out on the horizon, the FluidVision fluid-controlled accommodating IOL (Power Vision, Belmont, CA) utilizes natural muscular accommodating forces in the eye to transport fluids in the lens. This results in a shape change of the lens, similar to what occurs in the natural lens (changing from thin to thick upon accommodative effort), creating a large accommodative range. Roux has presented a study demonstrating clinically that the FluidVision accommodating IOL has the potential to achieve more than 5 diopters of power change.5
NuLens
Finally, there is the fascinating NuLens (NuLens Ltd, Herzliya Pituach, Israel), a novel design that mimics the accommodative mechanism of the avian eye. It uses changes in the refractive power of the lens to increase the accommodative effect. Flexible material is displaced through an opening in a diaphragm, creating a bulge. The curvature of this bulge determines the power of the lens. Implantation in primates has revealed a displacement of the lens of up to 0.80 mm with pharmacologic stimulation in the initial post-op period, and at 0.30 mm at 18 months. In addition, the change in curvature could add an additional 40 D of accommodative power, as determined with pharmacological stimulation.6
References
1. Sanders DR, Sanders ML. Visual performance results after Tetraflex accommodating intraocular lens implantation. Ophthalmology. 2007;114(9):1679-1684. Epub 2007 Mar 21.
2. Koch DD. Objective Evidence for Mechanism of Accommodation of the Synchrony Dual-Optic IOL. American Society of Cataract and Refractive Surgery Annual Symposium, 2009, San Francisco.
3. Packer M. The age of refractive lens surgery. Curr Opin Ophthalmol. 2005 Feb;16(1):1.
4. Amon M, Kahraman G, Schauersberger. Sulcoflex (Rayner 653L) a new IOL for implantation in the pseudophakic eye: Indications and first results. Presented at the XXIV Congress of the European Society of Cataract & Refractive Surgeons, Stockholm, 10 September 2007.
5. Roux P. Early Clinical Experience with PowerVision’s FluidVision Accommodating IOL. American Society of Cataract and Refractive Surgery Annual Symposium, 2008, Chicago.
6. Alió JL, Ben-nun J, Rodríguez-Prats JL, et al. Visual and accommodative outcomes 1 year after implantation of an accommodating intraocular lens based on a new concept. J Cataract Refract Surg. 2009 Oct;35(10):1671-1678.