New York Times Takes Note of Refractive Lens Exchange
The New York Times recently published a column on presbyopia correction highlighting Refractive Lens Exchange. However, the article opens with a description of an early stage Russian laser technology from an Ohio-based company called Oculatek (see Skin Deep: To Squint Or See The Light, by Camille Sweeney, January 1, 2009). I had never heard of Oculatek until I saw Sweeney’s article reprinted today in the Chicago Tribune (Taking long view on presbyopia: Light treatment a new option for loss of sight, Camille Sweeney, New York Times News Service, January 25, 2009). Searching Google, I found a press release dated 2006 stating that “Oculatek is a joint effort between 5iTech; EST, Inc., a medical electronics design company of Solon, Ohio and JSC MACDEL, a medical device company headquartered in Moscow, Russia.” To investigate further, I searched the MACDELweb site which states that “Our method … gives the hope to retain vision under any effects related to stress of eyes (computer, television, reading, games, etc.). This preventive method is most effective for the age period of 2 to 18 or 19 years. The procedures are contact-free, non-traumatic, and painless. MACDEL-00.00.09 infrared laser set for correction of accommodation and refraction disorders of vision. Therapy and prevention of myopia, amblyopia, nystagmus, strabismus, vision fatigue, prevention of complications after myopia correcting operations. The efficiency in elimination of accommodation spasm is close to 100 per cent.” The web site states that the application for presbyopia correction is under investigation. Jim Ohneck, president of Oculatek, wrote in an e-mail that “Our company is relatively new and the product is not FDA cleared at this time. The technology originated form Helmholtz Eye Institute and was originally developed for progressive myopia. Because the mechanism of action is to improve the flexibility of the ciliary muscle we felt there might be some potential here in the states for presbyopia.”
The Times article invested a significant amount of space in a discussion of Refractive Lens Exchange (RLE), and included an interview with Dave Harmon, president of Market Scope. His recent survey of 664 high volume US cataract and refractive surgeons forecasts a 6.3 percent increase in RLE for 2008 (for a total of 84,108 procedures). A procedure similar to RLE, cataract surgery with a presbyopia correcting intraocular lens (PC-IOL), represented 7 percent of all IOL implants in the third quarter of 2008, up from 5.5 percent in Q3-2007 (The Surgeons’ Quarterly Survey Report, December 31, 2008). The total number of IOL implants in the US in 2008 was about 3.1 million.
Intraocular lens technology (IOLs) and Refractive Lens Exchange (RLE) remain squarely based on the results of FDA monitored clinical investigations. It is true that, because presbyopia correcting IOLs have been investigated in the setting of cataract surgery, RLE remains an off-label procedure. The FDA approved labeling that comes with IOLs states that they are intended for use in conjunction with cataract surgery. However, the only real differences between cataract surgery and RLE are the presence of a cataract and the medical necessity of the procedure. RLE is performed to reduce or eliminate the need for glasses or contact lenses; it is not medically necessary. People who desire RLE can see just fine if they are wearing contact lenses or glasses. On the other hand, cataract surgery is performed primarily to improve the quality of vision by removing and replacing the eye’s clouded lens. People who need cataract surgery cannot see well, even if they are wearing contact lenses or glasses. Nevertheless, if I were examining one person who had cataract surgery and another who had RLE I would not be able to tell the difference – the eyes and the implants would look the same! Only the natural lens, which was removed, would have looked different (clouded or clear). The IOLs function in exactly the same way, whether used for cataract surgery or RLE; and, therefore, the results of FDA clinical investigations of these IOLs for cataract surgery supports their use for RLE (even though RLE is not specifically mentioned in the labeling).
Fortunately, the benefits of presbyopia correcting IOLs are available to both groups, patients who desire better vision having cataract surgery and those desiring freedom from bifocals having RLE. In the case of cataract surgery, the services associated with the correction of presbyopia are not covered by Medicare or commercial insurance carriers (simply because these services are not medically necessary). Medicare and other carriers do cover the implantation of a standard, or monofocal IOL at the time of cataract surgery. Patients who receive this type of implant will usually still require glasses. In May, 2005, the Center for Medicare and Medicaid Services (CMS) ruled that beneficiaries may upgrade to presbyopia correcting IOLs at the time of cataract surgery. (Later, CMS included toric IOLs for the correction of astigmatism in a similar ruling).
The IOL technology available in the US today for RLE includes several multifocal PC-IOLs and one accommodative PC-IOL. The most recent FDA approval arrived quite recently, on Friday, January 16, 2009. The aspheric, multifocal Tecnis IOL will soon be available from Advanced Medical Optics, Inc. (EYE, Santa Ana, CA). Investors may know that Abbot Labs (ABT, Skokie, IL) announced its forthcoming acquisition of EYE on Monday of that same week. The multifocal Tecnis has already proven successful outside the US, and several peer-reviewed published reports have demonstrated its superiority (see, for example, Hütz WW, Eckhardt HB, Röhrig B, Grolmus R. Intermediate vision and reading speed with array, Tecnis, and ReSTOR intraocular lenses. J Refract Surg. 2008 Mar;24(3):251-6; and Cillino S, Casuccio A, Di Pace F, Morreale R, Pillitteri F, Cillino G, Lodato G. One-year outcomes with new-generation multifocal intraocular lenses. Ophthalmology. 2008 Sep;115(9):1508-16). In fact, the FDA clinical investigation of the Tecnis multifocal IOL demonstrated that 85 percent of subjects implanted in both eyes never required glasses for any activity, including reading. I serve as Medical Monitor for the investigation, and will be presenting the results at the American Society of Cataract and Refractive Surgery Annual Symposium in San Francisco in April, 2009. Here is the abstract of my forthcoming presentation:
Efficacy and Patient Satisfaction with a Diffractive Aspheric Multifocal IOL
Mark Packer, MD
Purpose: To determine the effectiveness of a diffractive aspheric multifocal IOL vs. a monofocal IOL in improving uncorrected distance and near vision in presbyopic patients, and to measure patients’ level of satisfaction with the multifocal lens.
Methods: Multicenter (13 sites), evaluator-masked, parallel-group study with subjects assigned to bilateral implantation with either a diffractive aspheric multifocal IOL (Tecnis multifocal) or a monofocal IOL, depending on the patient’s preference. 125 subjects with a mean age of 66.4 were bilaterally implanted with the multifocal IOL and 123 subjects with a mean age of 68.7 were bilaterally implanted with the monofocal IOL. Both groups were followed for one year. No enhancements, including correction of residual astigmatism, were performed during this year.
Results: At 1 year, 71.1% (81/114) of multifocal subjects and 1.7% (2/113) of monofocal subjects achieved binocular Uncorrected Near Visual Acuity of 20/25 or better (p<0.001). 93% of the multifocal subjects achieved simultaneous Uncorrected Distance Visual Acuity of 20/25 and Uncorrected Near Visual Acuity of Jaeger 2 (20/25 equivalent). Approximately 85% of the multifocal group reported never using spectacles, compared to 5% of the monofocal group. Multifocal patients could read significantly faster than monofocal patients (148 vs.117 words per minute). Subjectively, patients rated the quality and sharpness of vision with the aspheric multifocal IOL very high. Even without enhancements, 94.6% of multifocal subjects said they would choose the same lens again.
Conclusion: A diffractive aspheric multifocal IOL provides excellent uncorrected acuity at all distances. Reading speed and acuity are significantly better than with a monofocal IOL and patient satisfaction is high.
The multifocal Tecnis joins the AcrySof Restor IQ from Alcon Labs (ACL, Ft. Worth, TX) and the ReZoom (EYE, Santa Ana, CA) as a new option for RLE. (The ReZoom is essentially a re-design of the older Array Multifocal IOL which we described in the Journal of Cataract and Refractive Surgery eight years ago [Packer M, Fine IH, Hoffman RS. “Refractive Lens Exchange With the Array Multifocal Lens.” J Cataract Refract Surg. 2002; 28:421-424]). The crystalens HD-100 (Bausch and Lomb, Rochester, NY) PC-IOL remains the only currently available accommodative IOL in the US (B & L was acquired by Warburg Pincus in 2007). In clinical trials today, the Synchrony dual optic accommodative IOL (Visiogen, Aliso Viejo, CA) may be the next device in this arena to win FDA approval.
Although Oculatek may prove a valuable technology, Refractive Lens Exchange is poised to become the main stream of presbyopia correction. Another technology mentioned in the article, Conductive Keratoplasty, (Refractec, Inc., Jenner, CA) was approved by the FDA for “temporary induction of myopia (-1.00 D to -2.00 D) to improve near vision in the non-dominant eye” but has now completely fallen by the wayside because of regression (the correction wears off). Those considering surgery should become educated in all the options available and review the clinical results with their surgeons before choosing a course of action.