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What
Does the NTIOL Status Mean for the Tecnis Acrylic?
The
importance of superior visual function is being recognized.
BY STEVEN DEWEY, M.D.
With the recent CMS ruling granting New Technology Intraocular Lens (NTIOL) status to the Tecnis IOLs, the government is recognizing something my patients have already known vision is not just Snellen-chart acuity any longer. The Tecnis IOLs (Advanced Medical Optics [AMO], Santa Ana, Calif.) are remarkable for their ability to deliver improved vision for the patient, not just in terms of Snellen acuity, but also in contrast sensitivity.
In this article, I will explain why I consider the Tecnis, and specifically the Tecnis Acrylic, as superior IOLs that I can use with confidence in the great majority of my cataract surgery patients, knowing that it will deliver a high level of visual function while receiving high marks for patient satisfaction.
Why an NTIOL Designation?
The NTIOL designation is linked to reimbursement
by the CMS when the IOL is implanted in a patient, and recognizes the expense and
effort summarized in the innovative characteristics of the IOL. In short, it raises
the allowable reimbursement for the IOL to an ASC from $150 to $200. In the bigger
picture, it sets a new standard for visual performance of our IOLs from which the
next generation of advances
can proceed.
The development of the original modified prolate anterior surface IOL led many cataract surgeons to speculate as to just what would the advantage be for this IOL when their current IOL choice already made patients happy. Many also questioned the "wavefront-designed" optic of the Tecnis, wondering if a lack of a thorough understanding of the fundamentals of Fourier or (the competing system) optics means our patients were receiving a disservice instead. In addition to this were minor concerns about technique, given that the original silicone Tecnis is designed with clear haptics and had no companion injection system, making it somewhat challenging to insert for some surgeons.
In more than 14 years of practice, I have encountered many patients with a "perfect" postoperative clinical appearance, but a far from perfect clinical result.
Typically, the description is of vague displeasure with the postoperative vision, despite demonstrating 20/20 acuity and an absolute lack of postoperative complications. This type of patient is undoubtedly a subset of the patients studied by Pager in which the standard VF-14 was used to assess preoperative and postoperative subjective visual function.1 He demonstrated that a significant portion of individuals still had difficulty with night vision and small print, two of the areas of greatest concern for individuals contemplating cataract surgery.
After hearing several presentations and reading a number of articles, I became convinced that the modified prolate optic of the Tecnis would be a benefit to my patients. As any prudent ophthalmologist would, I had several areas of concern I researched before incorporating the Tecnis into my practice.
Tecnis Acrylic: Three Major Advantages
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Figure. A well-centered Tecnis acrylic IOL. |
I was close to changing from using the Sensar with OptiEdge (AMO) to the silicone Tecnis when the Tecnis Acrylic became available. For me, the Tecnis Acrylic removed all of the barriers to the use of this advanced optic technology.
First, whether it is the original silicone Tecnis (based on the CeeOn 911 platform), or the Tecnis Acrylic (based on the Sensar with OptiEdge platform), the incidence of posterior capsular opacification (PCO) with these three-piece IOLs with squared posterior edges is demonstrated to be low.2 This feature guarantees that PCO will not interfere with the improved function of the aspheric optic.
Second, is the recognition that the function of these IOLs is dependent on proper technique and centration (Figure). Significant improvements in the implantation of these IOLs have come in the form of the Emerald series unfolders (AMO) for the Tecnis Acrylic, and the Silver series (AMO) for the silicone Tecnis.
While I am comfortable that modern foldable IOLs do maintain good function related to tilt and decentration regardless of insertion technique, I am even more confident that these insertion systems will allow for any surgeon to successfully implant the Tecnis-design IOLs on a consistent basis. My choice, the Tecnis Acrylic, has the same blue PMMA haptics as either the Sensar or Clariflex IOL (AMO), making visualization of the cartridge-loading process quite easy.
Third, and most important, is the valid demonstration that the wavefront-designed optic of the Tecnis enhances visual performance when compared to standard spherical IOLs.3 The Tecnis is the only currently available IOL with a design based specifically on correcting the measured optical aberrations of the eye.
Improved Reaction Time in Driving
Fundamentally, one of the challenges in the acceptance of this technology is that the improvement for the patient is not something visible at the slit lamp. Rather, the evidence for the enhanced visual function comes from fellow-eye studies comparing the Tecnis to spherical IOL designs.
By reducing the spherical aberration, the improvement in performance amounts to an extra 45 feet in distance when using a pedestrian target in a driving simulation, or an extra half-second of reaction time when driving at 55 mph. These parameters are better than published data for standard safety improvements, such as the elevated center brake light, which provides between 0.2 and 0.35 seconds of increased reaction time.
More than Just "Good Enough"
The simple design change of the Tecnis IOL the modified anterior prolate optic requires no modification in technique to successfully implant, nor any special testing equipment to recommend its use. Yet, it represents a tremendous improvement in visual function over standard IOLs, which have previously been deemed "good enough." I have been greatly impressed that fewer patients in my practice are reporting vague dissatisfaction with their vision with the Tecnis Acrylic IOL, and I am confident that this technology will result in improved function for our patients, not only in night driving, but also in simple mobility in dim-light conditions.
The recent granting of NTIOL status for this innovation in design is certainly well deserved, and will undoubtedly provide incentive for the next round of innovations in optical performance.
Steven Dewey, M.D., is a practicing ophthalmologist at The Colorado Springs Health Partners, Colorado Springs, Colo. Dr. Dewey has no financial interest in the information in this article. He can be reached by e-mail at deweys@prodigy.net.
References
1. Pager CK. Expectations and outcomes in cataract surgery: a prospective test of 2 models of satisfaction. Arch Ophthalmol. 2004;122:1788-1792.
2. Dewey S. Posterior capsule opacification. Curr Opin Ophthalmol. 2006;17;45-53.
4. Bellucci R, Scialdone A, Buratto L, et al. Visual acuity and contrast sensitivity comparison between Tecnis and AcrySof SA60AT intraocular lenses: a multi-center randomized study. J Cataract Refract Surg. 200;31:712-717.