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Small Aperture Technology Supplement October 2016 SMALL APERTURE TECHNOLOGY: Extending Depth of Focus for a Broad Spectrum of Presbyopic and Cataract Patients Supported by an educational grant from AcuFocus, Inc SMALL APERTURE OPTICS: A CONTINUOUS RANGE OF VISION Pinhole effect provides continuous extended, depth of focus without the disadvantages of monovision - Matteo Piovella, MD mall-aperture technology relies on the small With small aperture optics, the “near” eye still has excellent aperture, or pinhole effect to extend depth of distant vision, as described above. The visual system receives focus by blocking unfocused peripheral light two images that can be successfully converged. Pablo Artal rays and allowing only central light rays to reach PhD, and colleagues have demonstrated that small-aperture the retina. Initially introduced by AcuFocus, optics produce a benefit in stereoacuity compared to Inc. in the form of the KAMRA™ corneal inlay, it is now also monovision and that, even when a small aperture is combined S TM available for intraocular use. The IC-8 small aperture IOL with a small amount of mypoia, it preserves stereoacuity is a single-piece hydrophobic acrylic IOL embedded with a similar to that of normal binocular vision.1 central, opaque annular mask. The mask is 3.23 mm in overall Both patients and doctors can appreciate the benefits of diameter, with a 1.36-mm central opening, or aperture. implanting effective presbyopic IOL technology in one eye One year clinical data suggest that the IC-8 IOL functions only because it supports the most natural far vision with the like a premium lens with the ease of use of a monofocal IOL. most accepted IOL technology—aspheric monofocal IOLs—in It provides continuous vision over a wide range that includes the dominant eye. intermediate distance, without the quality-of-vision problems that have been associated with multifocal IOLs. When both Overcoming the major source of dissatisfaction Problems with driving, particularly at night, are a major eyes are plano, the small-aperture IOL provides functional source of dissatisfaction with bifocal multifocal technology, vision (20/40o or better) over 2.75 D of defocus. Aiming for and a significant barrier for my European colleagues and a slightly myopic target (-0.75 D) in the IC-8 eye extends that our patients in adopting presbyopia-correcting technology. range even further to provide continuous, functional vision By eliminating or significantly reducing the chance of such over 3.00 D of defocus (Fig 1). problems, small aperture technology can help surgeons build Monocular but not monovision a more successful refractive cataract practice. Both the KAMRA corneal inlay and the IC-8 small aperture A small aperture essentially provides continuous extended IOL are monocular technologies, designed for implantation depth of focus. This is what allows the patient to achieve into in a patient’s non-dominant eye. However, the result is near and intermediate vision, but the same effect is working quite different from monovision. on far distance, too, allowing for good vision even with some In the European post-market study for the IC-8 IOL, defocus or astigmatism present. mean monocular UCDVA was 20/25. This is the distance With a bifocal or trifocal IOL a patient who is -0.75 D + 1.00 D vision in a real-world setting, regardless of what refractive would have poor quality vision with glare and halo. If the symptoms target surgeons set or achieved. Distance-corrected (plano) are severe enough, explantation may be needed. This same and binocular far vision are even better, 20/20 and refractive result would provide excellent vision and high satisfaction 20/16, respectively. with the small-aperture lens. Another advantage over monovision is the maintenance Dr. Piovella is Medical Director of CMA (Centro of stereopsis with a small aperture. As we know, the visual MicrochirurgiaAmbulatoriale) in Monza, Italy, and serves as system detects the true distance of an object by merging President of the Italian Ophthalmological Society. He is a together similar images from the two eyes. When one of the consultant to AcuFocus, AMO and Carl Zeiss Meditec. images is grossly out of focus—as it will be coming from a Contact him at +39-39-389-498 or [email protected]. myopic eye in monovision—stereopsis is compromised and the resulting distance vision cannot be as accurate. This References: may be especially bothersome to the patient with previously 1. Fernández EJ, Schwarz C, Prieto PM, Manzanera S, Artal P. Impact on normal stereopsis before surgery. stereo-acuity of two presbyopia correction approaches: monovision and small aperture inlay. Biomed Opt Express. 2013; 4:822-830. “The greatest advantage of the IC-8 IOL, in my opinion, is that it is unlikely to cause problems with distance vision or driving, regardless of the refractive outcome.” Fig 1. When the IC-8 eye is target-corrected to -0.75 D and the monofocal eye is corrected to plano, patients achieve 3.00 D of continuous functional range of vision. Source: IC-8 IOL European post-market evaluation. 1 VISUAL QUALITY WITH THE IC-8™ IOL Impressive MTF curves show very high quality of vision compared to other presbyopia correction options - John A. Vukich, MD he IC-8 small aperture IOL is an aspheric, extended compared to the fellow eye implanted with an aspheric depth of focus (EDOF) lens that is commercially monofocal IOL. However, binocular CS at six months was not available in Europe. It is made of a hydrophobic affected; it remained equivalent to that of the monofocal IOL acrylic material with a high Abbe number, which eye. Contrast performance also continues to improve over means that different color wavelengths of light time with neuroadaptation. Tdisperse less through the material, reducing its chromatic The binocular nature of the distance vision with the IC-8 lens aberration. The lens has an embedded annular mask that also provides an important quality-of-vision advantage over focuses light through a central “pinhole” aperture, which monovision. Artal and colleagues have shown that binocular not only extends the depth of focus, but also allows it to summation (which is reduced with monovision but not with compensate for small amounts of defocus, astigmatism, and the small-aperture IOL) mitigates poor visual performance higher-order aberrations, further improving quality of vision. under low-luminance conditions.4 The IC-8 IOL meets ANSI standards for EDOF lenses. In summary, although light transmission to the retina is At 6 months, 97% of eyes have binocular uncorrected acuity reduced in an IC-8 IOL eye, studies of subjects implanted with of 20/25 or better for far distance, 87% have 20/25 or better this lens or with its corneal counterpart, the KAMRA inlay, for intermediate, and 81% have 20/32 or better for near. suggest that binocular summation and neuroadaptation allow patients to maintain very good contrast sensitivity. Impressive MTF curves Through-focus image quality modeling, performed at a Dr. Vukich is Surgical Director at the Davis Duehr Dean spatial frequency of 50 lp/mm using an ISO model eye and Center for Refractive Surgery in Madison, Wisc. He is a white light, shows that the IC-8 IOL provides higher overall consultant to Abbott Medical Optics and chair of the quality of vision and a longer continuous range of high Global Medical Advisory Board for AcuFocus, Inc. quality vision than any of the leading trifocal IOLs or the Contact him at [email protected]. Symfony lens (Fig 1). References: Unlike the distinct peaks in modulation transfer function 1. Waring GO, 4th, Correction of presbyopia with a small aperture (MTF) at each of the focal points that one sees with other corneal inlay. J Refract Surg 2011;27(11), 842-5. presbyopia-correction IOLs, the small-aperture lens provides 2. Seyeddain O, Hohensinn M, Riha W, et al. Small-aperture corneal high quality vision over a continuous range. That means inlay for the correction of presbyopia: 3-year follow-up. J Cataract that patients don’t have to find the “sweet spot” at which to Refract Surg 2012;38(1):35-45. hold reading material or a device, but can enjoy a more fluid, 3. Vilupuru S, Lin L, Pepose JS. Comparison of contrast sensitivity natural visual experience. and through focus in small-aperture inlay, accommodating intraocular lens, or multifocal intraocular lens subjects. Am J For extremely close work, the IC-8 IOL may prefer to Ophthalmol 2015;160(1):150-62. wear reading glasses, but for most patients that will be a 4. Schwarz C, Manzanera S, Artal P. Binocular visual performance worthwhile compromise, given the relative gains in visual with aberration correction as a function of light level. J Vision quality and intermediate acuity. 2014; 14:6. Binocular CS unaffected Some surgeons have been concerned that the method of action of a small aperture lens, because it blocks some light from reaching the retina, may affect contrast sensitivity (CS). Several studies of the KAMRA™ small aperture corneal inlay have now demonstrated that photopic and mesopic monocular contrast sensitivity (CS) remain within the range of the normal population one to three years after inlay implantation.1,2 KAMRA inlay subjects have also been shown to have significantly better binocular mesopic CS than subjects implanted with three types of presbyopia- correcting IOLs.3 In a substudy of the European post-market IC-8 IOL study, contrast sensitivity was slightly decreased in the IC-8 eye Fig 1. MTF curve comparison shows the IC-8 IOL has the broadest range of high quality continuous functional vision of the tested lenses. Source: Acufocus data on file 2 POST-MARKET EVALUATION OF THE IC-8TM IOL Procedure is straightforward; six-month data suggest that the small-aperture IOL provides an excellent range of vision at all distances - H.
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