The Evolution of Premium IOLs

The newest designs show steady progress. Here's what has improved and what's yet to come.

BY JERRY HELZNER, SENIOR EDITOR

The next generation of premium IOLs has arrived, with surgeons in general agreement that all three of the major players in the presbyopia-correcting lens marketplace have achieved measurable improvements in their products. But do the advances in these lenses and in torics represent a quantum leap in performance or are they merely incremental? It all depends on who you ask.

In a specialty that tends to attract perfectionists, it's not particularly surprising that though some surgeons emphasize how far the technology has come in recent years, others focus on the improvements that are still needed to replicate the vision provided by the natural lens of a young adult.

In order to get a range of more specific answers, Ophthalmology Management asked a number of the top cataract surgeons in the country to evaluate the newer options available to them in premium lenses. We were especially interested in how they assessed the newer lenses in comparison to the IOLs that were available 4 years ago, when the CMS made its landmark decision to allow patients to pay for the additional cost of premium lenses as part of a Medicare-covered cataract surgery procedure.

It is important to remember that although the perfect presbyopia-correcting IOL is still a hope for the future, the category represents today's best opportunity to provide better vision to older patients while enhancing practice profitability. This is especially true in the current economic downturn, with many practices allocating more of their marketing efforts to meeting the needs of the more financially stable senior population.

The New Premium Lineup

In 2005, a surgeon offering premium IOLs had choices that included two multifocals (the AcrySof IQ ReSTOR from Alcon and the ReZoom from Advanced Medical Optics), an accommodative (the Crystalens from Eyeonics) and the Staar toric, which at that time was designated as a New Technology IOL (NTIOL).

Today, the landscape has totally changed. Advanced Medical Optics was recently acquired by Abbott Labs and is now known as Abbott Medical Optics. Its flagship premium IOL is the recently approved aspheric Tecnis Multifocal. Eyeonics, which developed the Crystalens, was later purchased by Bausch & Lomb. The Crystalens that was available in 2005 was first supplanted by the Crystalens 5-0 and more recently by the Crystalens HD. Alcon has upgraded the original ReSTOR with the approval of the aspheric AcrySof IQ ReSTOR +3D and +4D. In addition, Alcon has added a new aspheric toric to its line of premium lenses, while the Staar toric has stood the test of time and remains in wide use after being re-designated in 2007 from NTIOL to being eligible for patient-shared billing.

Johnny Gayton, M.D., of Warner Robins, Ga., offers a view that is fairly typical of surgeon sentiment in assessing the lineup of current premium IOL options.

"While we still do not have an A+ lens, we are continuing to make progress in this area," says Dr. Gayton. He says patient feedback on the newer lenses is "very positive but still not perfect."

David R. Hardten, M.D., of Minneapolis, also has a positive but somewhat guarded assessment of the newer premium IOLs.

"I think that having more options available allows us to titrate the IOL to match the needs of the patients better, allowing us to have a lens that better matches the patient's visual demands. In general, the types of patients that have a reasonable chance of success are similar to what they were a few years ago, but there are still challenges to overcome. The patient who has a reasonable chance of being happy with a presbyopic IOL has a strong desire to have reduced dependence on glasses and contact lenses after IOL surgery, has an otherwise healthy eye with good visual potential, is willing to work through the extra hassle of the usual postoperative issues and is willing to pay extra in time and money for this reduced dependence."

Pros and Cons

While the comments of Drs. Gayton and Hardten represent the consensus view of the newer premium IOLs, some surgeons are more enthusiastic about next-generation lenses while others are less so.

For example, Mark Packer, M.D., of Eugene, Ore., is definitely in the enthusiastic camp. He cites impressive data from an FDA-monitored clinical trial in which 88% of the patients who received the Tecnis Multifocal reported never wearing glasses 4 to 6 months after surgery.

"These results give the Tecnis Multifocal the highest rate of spectacle independence, or freedom from glasses, of any intraocular lens studied so far in the United States," notes Dr. Packer.

Dr. Packer says he is now using the Tecnis Multifocal, the ReSTOR +3D and Crystalens HD, depending on the patient's specific goals — and that typical patient feedback is "Wow."

Jack Holladay, M.D., of Houston, is a bit more reserved in his judgment. Recent improvements in premium lenses are "incremental," he says. "Nothing that knocks my socks off." He still will not use a multifocal lens for any patient who will not accept a certain amount of nighttime glare and halo.

"You take a long-haul trucker who does a lot of night driving. You can't give him a multifocal because of the glare and halos," asserts Dr. Holladay. "You can eliminate the glare and halos by giving him a Crystalens, but then he might have trouble reading his manifest in the dim light of the truck cab. So, with these lenses, it's all about knowing the patient's needs and making compromises."

Why Newer Premiums Are Better

Every surgeon interviewed for this article agreed that the premium IOLs available in 2009 are better overall than the premium lenses that surgeons had to choose from in 2005. The least-approving appraisal of the newer options came from Steven Silverstein, M.D., of Kansas City, who called improvements "minimal and inconsistent between companies."

Jay Pepose, M.D., of St. Louis, enumerated what he considers to be the technical advances achieved by the lens manufacturers.

"The Crystalens has gone through two additional iterations since the original 4.5 mm design. The optic is now 5.0 mm, which is better for patients with larger pupils. The haptic design has changed, allowing more force transferred from the contracting ciliary body and compressed vitreous to be conveyed to the optic, resulting in a change in shape called accommodative arching. The central aspheric modification of the optic in the (Crystalens) HD creates greater depth of field and moves the optimum near focus in a myopic direction.

"The ReSTOR now comes in aspheric, which may improve its modulation transfer function (MTF). The (ReSTOR) 3.0 creates a more natural near focal point for the majority of patients, eliminating problems at intermediate distances, such as computer (viewing).

"The Tecnis Multifocal also has the benefit of aspheric optics and is less pupil-dependent than other multifocals." Like many of his colleagues, Dr. Pepose notes that "all multifocal lenses still have a higher incidence of night glare and reduced contrast compared to accommodating or monofocal IOLs.

"The Alcon toric, now available as an aspheric design, offers rapid visual rehabilitation for patients with high degrees of corneal astigmatism."

Premium IOLs in Practice

William Lahners, M.D., of Sarasota, Fla., points to the introduction of aspheric optics as "the single biggest improvement in premium IOLs." Dr. Lahners says the new Tecnis and ReSTOR aspherics are able to "balance out" existing spherical aberrations, reducing distortion, glare and halos. He says the aspheric lenses are contributing to better quality of vision and greater patient satisfaction.

"I also believe we have been able to shorten the neuroadaptation process so that patients are seeing better sooner," he says. "Some of that is because of better lens technology and some is from experience with the patient-selection process. It's difficult to measure but that's been my observation."

Like other surgeons, Dr. Lahners will mix lenses if he believes it will benefit the patient. He finds that initial implantation of a Tecnis Multifocal in the non-dominant eye, followed by a Crystalens HD in the dominant eye, is often a good combination.

Dr. Lahners also says that some types of patients who were either not premium IOL candidates or only marginal candidates in the past can now be given a premium lens.

"Someone who had myopic LASIK or even RK would not have been a good candidate previously because they had so much spherical aberration that we couldn't use a multifocal lens," he notes. "But with the aspheric lenses that we have today, they become good candidates. In addition, I would be comfortable in giving the Crystalens HD to a patient who had early macular changes — but not full-blown AMD. The Crystalens doesn't split the light. That's an important consideration for someone who has macular changes."

Adds David Chang, M.D., of Los Altos, Calif. "Multifocal IOLs reduce contrast sensitivity, and while the clinical effect on early AMD is not known, I would not use them in patients who already manifest early maculopathy. These patients will be less likely to achieve the near uncorrected acuity they desire, and I offer them a monofocal or accommodating IOL."

(Editor's note: Some surgeons have reported using a ReSTOR IOL in patients with stable, dry AMD, including Dr. Gayton, who now implants the aspheric ReSTOR +4.0 in AMD patients whom he deems as appropriate candidates. Subjective quality-of-life statements he collected pre- and postoperatively indicate improved visual function and better lifestyle quality with ReSTOR implantation. The use of multifocals in patients with AMD remains a contentious topic that Ophthalmology Management will address in a future article).

Farrell (Toby) Tyson, M.D., of Cape Coral, Fla., is also having success with the new aspheric premium IOLs. He says the newer lens options now enable him to provide a range of specific choices that offer less glare and halo, better intermediate vision and a more comfortable reading position.

"With today's lenses, we've expanded the percentage of the patient population who are good candidates for premium lenses," says Dr. Tyson. "We've increased our premium conversions from 15% of cataract surgery patients to 27%."

And Uday Devgan, M.D., of Los Angeles, notes that "the Tecnis Multifocal allows us to implant a diffractive multifocal that is not pupil-dependent — this is a benefit to patients with larger pupils who may not have previously been good candidates for diffractive multifocals."

Two Views on Additional Candidates

One of the areas where surgeons disagree is the question of whether the new IOLs are creating more candidates for premium lenses. While most of the surgeons interviewed for this article, such as those quoted above, say that the new IOLs are expanding the number of candidates, others see it differently.

"I don't think [the new premium IOLs] have increased the number of candidates," says Michael Korenfeld, M.D., of Washington, Mo. "The pool is still primarily limited by economics, not so much technology."

Dr. Silverstein adds "though our volume has increased, the technology has minimally changed the patient profile." He does note that, like Dr. Lahners, he now feels comfortable in using the newer Crystalens 5-0 and HD in patients with mild, stable retinal disease.

But even those surgeons who see the premium patient pool as still limited report having good results and high rates of patient satisfaction with the premium lenses that they do implant.

Dr. Korenfeld says his "success rate is close to 100%" with the Crystalens and also very high with the AcrySof toric, the only two premium lenses that he currently uses. Dr. Silverstein says that 95% of his approximately 2,000 premium IOL patients "are pleased with their outcomes." He also tells "every appropriate patient that this is the lens I will have in my eyes when my time comes."

Premium Torics Find Favor

In the toric category, the Staar toric has been a dependable lens for more than a decade while the more recently approved Alcon AcrySof toric is receiving excellent reviews from the surgeons who use it.

"The Alcon toric is a home run," asserts Alan Aker, M.D., of Boca Raton, Fla. "This will be available to a greater number of patients if Alcon can gain FDA approval for higher amounts of astigmatism."

"I like the Alcon toric IOLs, particularly the T5 model, which corrects +2D at the corneal plane, and more so now that they are available in an aspheric version," says Dr. Devgan. "I wish that there were higher corrections such as +3D or +4D at the corneal plane for those higly astigmatic patients."

Dr. Devgan says he uses the toric IOLs for patients with +2D or more of corneal astigmatism and does limbal relaxing incisions (LRI) for +1.5 D or less of corneal astigmatism. Several other surgeons interviewed reported similar parameters for their use of torics.

Dr. Chang notes that "toric IOLs are a wonderful adjunct to LRIs for management of astigmatism during cataract surgery. In addition to preferring them for higher amounts of astigmatism, I also favor them for younger cataract patients (LRIs are much more effective with greater corneal rigidity characteristic of older patients) and for astigmatism that is not of a classic bow-tie pattern on topography."

Dr. Korenfeld says that "if patients don't want to pay for the AcrySof toric and the setting is right, I will still do LRIs, but they are definitely less accurate and precise."

Larry Patterson, M.D., of Crossville, Tenn., says "in terms of stability, the Alcon toric is a huge improvement."

And Kevin Waltz, M.D., of Indianapolis, notes "with the torics, we can now cover the cost of the lens and the extra services. This increases the likelihood of their use." He also notes that "the greater number of toric power options is very helpful and getting better."

The Premium Wish List

While most of the surgeons interviewed were complimentary regarding the progress made thus far in premium lens technology, they were unanimous in their belief that further advances are needed.

The most often-expressed wish is a lens with 3 D of true accommodation that would essentially replicate the healthy lens of a 35- to 40-year-old adult. Some surgeons say the ideal of replicating the 20-year-old eye is possible, especially with some of the investigational lens concepts that are currently being studied.

Here's what some of the surgeons say they hope for in future lens technology:

Dr. Patterson: "even better accommodative IOLs with better consistency and stability."

Richard Lindstrom, M.D., Minneapolis: "accommodating IOL with 4+D accommodation. Power adjustable."

Dr. Packer: "Negatively aspheric, coma-compensating accommodative structure. An accommodative IOL with higher amplitude such as the Visiogen Synchrony may get us closer to that ideal."

The Synchrony is a dual-optic lens linked by spring haptics. It is currently approved in Europe but could be coming to these shores before long.

Dr. Chang is the medical monitor for the U.S. phase 3 trial of the Synchrony.

"With more than 480 eyes implanted, we anticipate submission to the FDA later in 2009," he notes. "This is the first dual-optic accommodating IOL, and can be implanted through a clear-corneal incision thanks to a pre-loaded injector. Preliminary data reported at the last AAO meeting by Ossma and colleagues from Colombia indicates better contrast sensitivity and distance-corrected intermediate acuity when compared to the spherical ReSTOR 4.0. Most importantly, halos and glare were not an issue."

Dr. Tyson: "Toric multifocals. Accommodatives with better reading vision."

Dr. Devgan: "How about more options in the premium channel? Presbyopia and astigmatism are great, but what about other options?"

Dr. Waltz: "fewer side effects. More variety of cylinder powers. More accommodation."

Dr. Korenfeld: "more lenses that achieve near vision through mechanisms that don't split and redistribute light."

Dr. Pepose: "Toric versions. Accommodating IOLs with increased near."

Dr. Silverstein: "no halos, better optics."

Dr. Holladay: "The ideal is a lens that matches the original we possess when we are 19 years old and performance is optimum. This is a journey and we're not there yet."

Not "there" yet, but getting closer. OM