Premium IOLs may present a growth opportunity in a slumping economy

Ophthalmologists will see an increase in the number of age-related ocular pathologies, notably presbyopia, in the coming years. A 2004 report in Harvard Generation Policy Journal estimated that 90 million Americans were between the ages of 40 to 58 — the age range when loss of accommodation begins to occur.

“I think we’re only going to see an increase in presbyopia correction. Given the current economy, we might see a dip right now because people aren’t going to be spending, just like the LASIK community has dipped, too, just because it is also more of an elective cosmetic procedure,” Rosa Braga-Mele, MD, OSN Cataract Surgery Section Editor, said. “But I think in the long run, we’re going to see a higher incidence of refractive IOL procedures and presbyopia cornea corrections because of the aging baby boomer generation and generation X coming up after them.”

According to Market Scope, about 420,000 presbyopia-correcting IOLs were to be implanted worldwide in 2008, up from about 301,000 in 2007. In the United States, the number was expected to jump from 153,000 to 210,000, and about 7% of all lens implants in 2008 were expected to involve a premium lens.

“If we look at the trend in Medicare data just in the last 5 years, the volume of cataract surgery has increased every year. It is currently hovering around a 3-million-per-year mark. With a population of around 300 million, that’s around 1% of the population per year,” OSN SuperSite Section Editor Uday Devgan, MD, FACS, said. “That’s expected to increase steadily over the next couple of years.”

The market for presbyopia correction will increase as the size of the baby boomer generation continues to grow and should peak around 2020. “I think we’ll be doing up to 4 million cataract surgeries a year, maybe even more than that,” Dr. Devgan said.

Patient counseling is recommended to determine the most appropriate IOL choice, according to Rosa Braga-Mele, MD. Image: Lalich M

The number of surgeons offering premium IOLs is also increasing. According to a survey of cataract and refractive surgeons cited by Market Scope, 71% of U.S. surgeons are offering premium IOLs in their practice, up from around 59% in 2007. Based on those findings, the tracking group predicted there would be 37% growth in the premium IOL market during 2008.

The growth in providers offering these lenses may be a matter of supply and demand, according to OSN Practice Management Section Editor John B. Pinto.

“Medical device innovators and investors will continue to contour the boomer market, which bodes well for a bloom of interesting and important new procedures in the years ahead … limited only by the tolerance of already overwhelmed surgeons to learn yet something else new and make practice and promotional investments in a softening economy,” Mr. Pinto said.

The increase in premium IOLs may reflect, in part, the demands of the current down economy, which has already caused a dip in LASIK procedures. According to Mr. Pinto, premium IOLs are an attractive refractive service to add to a practice because they require less capital outlay for practices that already offer cataract surgery and because the learning curve is less steep than laser-based surgery.

“A couple of generations ago, surgical and medical tools were limited, and ophthalmology was a rather generalized, full-service, one-stop business. As new treatment tools and methods proliferated, there was a shift toward narrow specialization. That tide is now turning back very slightly,” Mr. Pinto said.

“The current economic climate has most ophthalmologists and their administrators turning over every possible stone for new services to offer to patients,” he said. “LASIK-based surgeons are working hard to reposition their practices to serve geriatric patients after an often long hiatus from cataract surgery and disease management.”

Contrast sensitivity

There are three primary choices in presbyopia-correcting IOLs: the ReSTOR (Alcon) and the ReZoom (Advanced Medical Optics) multifocal lenses and the monofocal accommodative Crystalens (Bausch & Lomb).

Uday Devgan

Each of these lenses has recognized strengths and weaknesses. Clinical studies show that ReSTOR supplies the best near vision of all three, while ReZoom may be best suited for patients with visual needs at intermediate distance. Crystalens offers consistent correction across all zones, if not to the same degree as the multifocal lenses.

Multifocal lenses sacrifice contrast sensitivity, according to OSN Optics Section Editor Jack T. Holladay, MD, MSEE, FACS, because the defocused image of one focal zone is necessarily superimposed on top of other focal zones. Contrast sensitivity is less of an issue with the Crystalens, but it may not deliver the quality of near vision some patients are seeking, according to Dr. Holladay.

The newest Crystalens model, the Crystalens HD, may correct some of the near-vision deficiencies of the Crystalens Five-O by using a small add in the central zone, which has provided almost a line improvement in near vision, according to Dr. Holladay. The Crystalens HD has been available in the U.S. since July, according to the Bausch & Lomb Web site.

Dr. Holladay also added that contrast sensitivity, which diminishes with age, is improved with monofocal aspheric lens models by an additional 20% to 30%.

“Aspheric multifocal IOLs, which we’ll see probably in the next year, will end up as good as spherical monofocal IOLs,” Dr. Holladay said. “The result may be a greater percentage of patients and doctors might choose this more often.” The Tecnis Multifocal IOL (AMO) is pending approval from the U.S. Food and Drug Administration.

Harnessing the strengths

Jack T. Holladay

The strengths and weaknesses of each lens are apparent in relation to other lens choices. For instance, both the ReSTOR and the ReZoom improve near and distance vision, but near vision is better with the ReSTOR, while intermediate vision is better with the ReZoom. By comparison, Crystalens HD measures near at 16 inches and distance at 32 inches, while the ReSTOR improves near vision to about 12 inches to 14 inches.

As a result, many surgeons are now putting added emphasis on preoperative protocol, screening, counseling and careful patient selection. It is a move toward matching the lens to the patient rather than the patient to the lens.

“All of the lenses that are out there have some degree of compromise. But knowing what you know, you should be able to pick a reasonable choice and know that the compromise with each lens is in line with what the patient wants,” Dr. Devgan said. “The doctor must do the math himself, and the doctor must make a specific recommendation.”

As part of patient counseling, some surgeons are starting to look not only at the patient’s preoperative visual abilities and postoperative needs, but also whether the patient is a viable candidate for the proposed implant.

“You have to be somebody who’s not only a good technician, you have to be somebody who’s aware of the patient’s personality profile and make sure you pick the right person to put the implant in,” Dr. Holladay said.

According to Dr. Devgan, accounting for personality might mean denying implants to some patients, but that may not be a bad thing.

“If I have a patient who is completely unrealistic and I know that my technology cannot reach their expectation, I have a duty to tell them that,” Dr. Devgan said. “The most important part of surgical judgment is knowing when not to do surgery.”

That sentiment was echoed by several surgeons interviewed by Ocular Surgery News who work with premium IOLs. Increasingly, surgeons do not want to perform a procedure in a patient who has unreasonable demands for the expected outcome.

“If their expectations are too high, you want to back them out of the procedure because you will never be able to meet their expectations. The type A or perfectionist personality is not the right personality for this procedure,” Dr. Braga-Mele said.

Explaining to patients what to expect after surgery will increase preoperative chair time, as will thorough assessment of the health of the eye, but taking these steps will help improve postoperative success.

“Not only is personality or counseling important, but it’s also important to look at the type of eye you are dealing with,” Dr. Braga-Mele said. “Counseling will increase your chair time before surgery, but if you don’t do that, it will definitely increase your chair time after surgery with a now unhappy patient.”

According to Dr. Devgan, aiming for patient satisfaction does not discount the need for accurate biometry and assessment of the health of the eye; instead, happiness is the key to successful surgery, on par with correcting a cataract or refractive error.

“We want to give patients a really great experience. Giving a great surgical result is paramount to that, but it’s not the only thing,” Dr. Devgan said. “If you want to do refractive cataract surgery, you have to deliver refractive results.”

Diagnostic screening and biometry

Premium IOLs are prompting a shift in cataract correction toward refractive surgery, in which enhanced postsurgical vision is expected. Dr. Devgan said that about 40% of patients in his practice have a previous history of refractive surgery, and this population presents unique demands for resulting vision.

“We do about a million LASIK per year, and certainly those patients are getting cataract surgery,” Dr. Devgan said. “These are people who paid out of pocket for LASIK to get out of glasses, and so they don’t want cataract surgery to get back into glasses.”

Even absent previous refractive surgery, surgeons are increasingly faced with patients demanding spectacle independence. To some surgeons, that signals a need to improve screening and biometry.

In an editorial in the November issue of American Journal of Ophthalmology, Jay S. Pepose, MD, PhD, said that “remaining challenges for both clinicians and industry to address in partnership include the need for better diagnostic tools: 1) to assess patient needs and neural processing ability during the preoperative selection process, 2) to determine total optical characteristics to more accurately predict postoperative IOL performance based on ray-tracing models, and 3) to measure outcomes uniformly to help refine future lens development.”

Dr. Pepose suggested that corneal or intraoperative wavefront analysis should be considered for premium IOL implantations. Surgeons should be preoperatively evaluating the tear film, ocular surface, corneal pachymetry and topography, and performing a full LASIK refractive assessment, he said, because some patients may require laser enhancement postoperatively for residual astigmatism or if the preoperative target is not met.

Making the most of the lenses

Because of the visual concessions necessary with each lens choice, surgeons are employing strategies that allow them to take advantage of the strengths of each premium lens choice while minimizing compromises. One example is mini-monovision with multifocal and accommodative lenses, including the Crystalens, in which the dominant eye is corrected to plano, and the fellow eye is targeted to –0.5 D or –0.75 D, resulting in a deeper field of focus after neural adaptation.

According to Dr. Braga-Mele, most patients do not notice the refractive difference, and the myopic defocus results in clearer vision across all three vision zones, more closely mimicking the visual abilities of natural accommodation.

Jason E. Stahl

Some surgeons, such as Jason E. Stahl, MD, still use traditional monofocal lenses in pseudophakic monovision to correct presbyopia. He said that patients with previous refractive surgery may be good candidates for this type of correction.

“These patients have been using monovision sometimes for many years following LASIK, RK or PRK,” Dr. Stahl said. “Their brains have already adapted to that type of vision, and so I think it’s the easiest and simplest way for them to adapt to surgery.”

Dr. Stahl also combines presbyopia-correcting IOLs in some patients. There has been suggestion that combining IOLs, or mix-and-match, may result in delayed neural adaptation because of competing vision compromises. However, Dr. Stahl has yet to experience that problem in more than 3 years of combining presbyopia-correcting IOLs.

Combining lenses theoretically harnesses the advantages of one lens to compensate for the compromises of the fellow lens. Because each lens has advantages at near, distant or intermediate vision, combining lenses may expand both quantity and quality of vision.

“It’s about trying to take the strengths of each technology and use them to give the patient an overall better outcome,” Dr. Stahl said.

Originally a proponent of pairing a ReZoom lens in the dominant eye with a ReSTOR lens in the fellow eye, Dr. Stahl has changed his practice to use a Crysta-lens in the dominant eye based on an evaluation of his results.

“When we looked at the combination of ReSTOR-ReZoom, the combination of Crystalens-ReSTOR and the combination of bilateral ReSTOR, what we found was that even though we had the similar range of vision from distance to near with ReZoom-ReSTOR and Crystalens-ReSTOR, there were significantly more halos at night if the patient had the ReZoom in the dominant eye as opposed to the Crystalens in the dominant eye,” Dr. Stahl said. “Based on that, it changed the way I approach patients, to the point where I no longer offer the ReSTOR-ReZoom combination.”

Dr. Stahl noted that he plans to publish the results of his study, but that the Crystalens HD may change his practice habits again toward more bilateral implantations. Still, although combining IOLs is not a strategy for all patients and all scenarios, nor even for all surgeons, “there may always be an advantage in combining lenses if there are different technologies that can improve a patient’s vision,” he said.

“I know some doctors have gotten great results,” Dr. Braga-Mele said, “but I still have a problem with the brain having competing visual images and that it may not fuse the images well, and the long-term consequences of different competing halos and glare from a diffractive and refractive multifocal lens, or a diffractive and an accommodative IOL, are just unknown.”

There may be instances in which a different kind of mix-and-match is useful, Dr. Braga-Mele said. In Canada, the ReSTOR IOL is available in +4 D and +3 D add models (approval is pending from the FDA for the +3 D add ReSTOR); Dr. Braga-Mele said she has used the +3 D in one eye to push the near vision back to make up for loss of intermediate vision with the +4 D model implanted in the fellow eye.

Using the compromises

The use of these surgical strategies expands the menu of options for presbyopia correction. According to Dr. Devgan, a discussion of premium IOLs should include traditional aspheric monofocal lenses because when used in mini-monovision or in bilateral implantation, they can be implanted without additional cost to a patient with cataract. As well, toric lenses, although not considered presbyopia-correcting lenses, offer the added benefit of correcting astigmatism in patients with presbyopia.

Because each lens choice provides vision improvement in different areas, each lens will be uniquely suited to different patients with different visual needs, Dr. Devgan added. For patients desiring distance correction with good intermediate vision, such as an avid golfer or someone who uses a computer frequently, the refractive ReZoom IOL may be the best choice.

“Because the central 3 mm of that lens is distant dominant, that tends to be great for long distance in the sun,” Dr. Devgan said. “When you look a little closer, the pupil gets a little larger, and you start to get the reading add. The downside with that lens, of course, is that it increases the instance of nighttime glare and halo. But most patients get accustomed to that.”

Patients needing close near vision and distance correction and who may not use intermediate vision as frequently – a knitter or a fly fisher, for example – may be better suited to the diffractive ReSTOR lens.

“The ReSTOR has a strong read and has good distance, but is lacking in the intermediate, so maybe not the best for computer vision. In addition, there have been some reports of waxy vision with the lens, and that needs further evaluation,” Dr. Devgan said.

For patients who require more stable vision across all three vision zones and is not pronounced in any one zone or for patients who might be unwilling or unable to accept visual dysphotopsias – a patient who drives at night, for example – the Crystalens may be the best option.

“While the Crystalens HD lenses are not magic – they certainly don’t give the near vision of a 22-year-old – they do have the ability to give a wide range of very quality vision without the inherent compromise of a multifocal lens,” Dr. Devgan said.

The bottom line, according to Dr. Devgan, is that the current technology is good enough to meet patient demands if used properly and in the right patient.

“The technology gets better and better every year. We’re where we were with excimer lasers in the late 1990s. You had these first-generation excimer lasers that were … OK. But the ones we’re using now for LASIK are just so much better. This is the same thing with the premium lenses. We have just the first couple initial generations of presbyopia lenses,” Dr. Devgan said. “There is zero doubt in my mind that with the incentives for everyone involved, that the technology will only get better.” – by Bryan Bechtel

Should patients be given a menu of different IOL options, or should the surgeon find the best fit and recommend that one?

References:

• The Age Explosion: Baby Boomers and Beyond. Harvard Generations Policy Journal. Winter 2004.
• Alfonso JF, Fernández-Vega L, Baamonde MB, Montés-Micó R. Prospective visual evaluation of apodized diffractive intraocular lenses. J Cataract Refract Surg. 2007;33(7):1235-1243.
• Alió JL, Tavolato M, De la Hoz F, et al. Near vision restoration with refractive lens exchange and pseudoaccommodating and multifocal refractive and diffractive intraocular lenses: comparative clinical study. J Cataract Refract Surg. 2004;30(12):2494-2503.
• Chang DF. Prospective functional and clinical comparison of bilateral ReZoom and ReSTOR intraocular lenses in patients 70 years or younger. J Cataract Refract Surg. 2008;34(6):934-941.
• Chiam PJ, Chan JH, Aggarwal RK, Kasaby S. ReSTOR intraocular lens implantation in cataract surgery: quality of vision. J Cataract Refract Surg. 2006;32(9):1459-1463.
• Chiam PJ, Chan JH, Haider SI, et al. Functional vision with bilateral ReZoom and ReSTOR intraocular lenses 6 months after cataract surgery. J Cataract Refract Surg. 2007;33(12):2057-2061.
• Choi J, Schwiegerling J. Optical performance measurement and night driving simulation of ReSTOR, ReZoom, and Tecnis multifocal intraocular lenses in a model eye. J Refract Surg. 2008;24(3):218-222.
• Cummings JS, Colvard DM, Dell SJ, et al. Clinical evaluation of the Crystalens AT-45 accommodating intraocular lens: results of the U.S. Food and Drug Administration clinical trial. J Cataract Refract Surg. 2006;32(5):812-825.
• Freeman W. Global demand for presbyopia-correcting IOLs grows. Market Scope. 2008;13(8):1,4-6.
• Goes FJ. Visual results following implantation of a refractive multifocal IOL in one eye and a diffractive multifocal IOL in the contralateral eye. J Refract Surg. 2008;24(3):300-305.
• Macsai MS, Padnick-Silver L, Fontes BM. Visual outcomes after accommodating intraocular lens implantation. J Cataract Refract Surg. 2006;32(4):628-633.
• Marchini G, Pedrotti E, Sartori P, Tosi R. Ultrasound biomicroscopic changes during accommodation in eyes with accommodating intraocular lenses: Pilot study and hypothesis for the mechanism of accommodation. J Cataract Refract Surg. 2004;30(12):2476-2482.
• Pepose JS. Maximizing satisfaction with presbyopia-correcting intraocular lenses: the missing links. Am J Ophthalmol. 2008;146(5):641-648.
• Pepose JS, Qazi MA, Davies J, et al. Visual performance of patients with bilateral vs combination Crystalens, ReZoom, and ReSTOR intraocular lens implants. Am J Ophthalmol. 2007;144(3):347-357.
• Souza CE, Muccioli C, Soriano ES, et al. Visual performance of AcrySof ReSTOR apodized diffractive IOL: A prospective comparative trial. Am J Ophthalmol. 2006;141(5):827-832.
• Terwee T, Weeber H, van der Mooren M, Piers P. Visualization of the retinal image in an eye model with spherical and aspheric, diffractive, and refractive multifocal intraocular lenses. J Refract Surg. 2008;24(3):223-232.

• Rosa Braga-Mele, MD, FRCS, can be reached at 245 Danforth Ave., Suite 200, Toronto, Ontario, Canada M4K 1N2; 416-462-0393; fax: 416-462-3612; e-mail: rbragamele@rogers.com. Dr. Braga-Mele is a paid consultant for Bausch & Lomb, AMO and Alcon
• Uday Devgan, MD, FACS, can be reached at Maloney Vision Institute, 19021 Wilshire Blvd. #900, Los Angeles, CA 90024; 310-208-3937; fax: 310-208-0169; e-mail: devgan@ucla.edu; Web site: www.maloneyvision.com. Dr. Devgan is a consultant to AMO, Bausch & Lomb and STAAR Surgical. He is a stockholder in Alcon and AMO and has study funding from AMO and Bausch & Lomb.
• Jack T. Holladay, MD, MSEE, FACS, can be reached at Holladay LASIK Institute, Bellaire Triangle Building, 6802 Mapleridge, Suite 200, Bellaire, TX 77401; 713-668-7337; fax: 713-668-7336; e-mail: holladay@docholladay.com; Web: www.docholladay.com. Dr. Holladay is a consultant for Advanced Medical Optics.
• Jay S. Pepose, MD, PhD, can be reached at Pepose Vision Institute, 1815 Clarkson Rd., Chesterfield, MO, 63017; 636-728-0111; e-mail: jpepose@peposevision.com; Web site: www.peposevision.com. Dr. Pepose is a consultant for Bausch & Lomb.
• John B. Pinto can be reached at J. Pinto & Associates Inc., 1576 Willow St., San Diego, CA 92106; 619-223-2233; e-mail: pintoinc@aol.com; Web site: www.pintoinc.com. Mr. Pinto – no disclosures.
• Jason E. Stahl, MD, can be reached at Durrie Vision, 5520 College Blvd., Suite 201, Overland Park, KS, 66211; 913-491-3330; fax: 913-491-9650; e-mail: jstahl@durrievision.com.Dr. Stahl has no financial interests to disclose.