A Patient-Centric View of Premium IOLs

When picking which premium IOL is best for a patient, consider the patient’s visual needs and lifestyle. And, treat him or her like family.

By Jim Owen, O.D., M.B.A.

Goal Statement:

Each patient who walks into your practice needing an IOL deserves your complete attention and best efforts—just as if you are family. Make sure to match each patient to the IOL that will most benefit him or her. Consider patients’ lifestyle and visual needs, and thoroughly explain the pros and cons of each lens.

Faculty/Editorial Board:

Jim Owen, O.D., M.B.A.

Credit Statement:

This course is COPE approved for 2 hours of CE credit. COPE ID 27037-RS. Please check with your state licensing board to see if this approval counts towards your CE requirement for relicensure.

Joint-Sponsorship Statement:

This continuing education course is joint-sponsored by the Pennsylvania College of Optometry.

Disclosure Statement:

Dr. Owen is a consultant to TLC Laser Eye Center, and he is on the Speakers’ Bureau of Allergan, Abbott Medical Optics and Bausch & Lomb.

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My mother had cataract surgery last summer, and we all had many choices to make regarding the type of lens to implant into her eye. You bring every patient through this same process, but with your mother, there is this voice—her voice—that amplifies any decision. So, we had many conversations. I never once said “apodization” or tossed around other jargon, but we did cover all her options completely, exactly how I would with any other patient.

The decision of what type of IOL to insert in a patient’s eye is relatively new. The first multifocal IOL, the Array (AMO) was FDA approved in 1997, and the first toric IOL, AcrySof Toric (Alcon), was FDA approved in 2005. Before then, the choice of IOL was based largely on the surgeon’s preferred insertion technique and materials.

Now, however, more factors— such as optimal vision correction—must be taken into account. Currently, three IOLs that help a patient’s near vision and two IOLs that correct astigmatism are available. This article reviews these lenses and how they will impact your patient’s life and vision.

Toric IOLs

A toric IOL, such as AcrySof Toric or the STAAR Toric (STAAR Surgical), is the simplest IOL to describe to patients with sufficient corneal cylinder. Toric IOLs’ powers range from -1.50D to -3.00D, giving them an effective power of up to -2.00D at the corneal plane. Higher amounts of astigmatism can be managed with limbal relaxing incisions. Accurate corneal cylinder measurements are required, either through keratometry or IOL Master measurement.

Patients whose astigmatism is less than 1.25D can have it corrected with the placement of the incisions. In cases of stronger astigmatism, a toric lens does very well.

Patients who might not be as successful with a toric IOL are those who have an unstable capsular bag or demonstrate pseudoexfoliation and/or weak zonules. In these patients, the lens may rotate once implanted, altering the patient’s vision. But, one study reported that 93.9% of eyes corrected with toric IOLs were within 0.50D of attempted cylindrical correction, and that 66% of eyes were within 20/20 uncorrected visual acuity.¹

Currently, neither toric lens is able to correct near vision.

Diffractive and Plate Haptic IOLs

Some patients should consider lenses that can correct near vision as well as distance vision. Two of the following lenses use diffractive technology, and the third accommodates through a plate haptic design. All three of these lenses are second generation or later and include improvements on the original lenses.

• Tecnis Multifocal IOL. The Tecnis Multifocal IOL (Abbott Medical Optics) uses an aspheric optic design to offset the spherical aberration of the cornea. The lens has a prolate (curved centrally and flattened peripherally) anterior surface with 0.27µm of negative spherical aberration and a posterior surface with diffractive rings to provide the near and distance images.

According to FDA data, the Tecnis Multifocal IOL provides both good near and distance vision.² At four to six months, binocular uncorrected visual acuity was 20/22 and distance-corrected near vision was 20/23. But, this study also found patients’ reading speeds to be 175 words per minute in bright light and 142 words per minute in low light.

Overall, the Tecnis Multifocal IOL provides good vision for patients at near and far. In a study comparing the Array, ReZoom (AMO) and Tecnis Multifocal IOL, 87% of patients were spectacle free with the Tecnis Multifocal IOL vs. 53.3% with the ReZoom lens and 43.7% with the Array lens, demonstrating the apparent superiority of the diffractive technology.³

• The Acrysof ReStor. The first diffractive lens approved was the Acrysof ReStor 4.0 Multifocal IOL (Alcon). Recently, Alcon received approval for a 3.0 version of the ReStor lens. The ReStor 4.0 is a single piece, aspheric, ultraviolet and blue light-blocking diffractive lens. It uses the mathematical concept of apodization to produce a gradual blending of the diffractive steps as small as 0.2µm in the lens.

The difference between the 4.0 version and the 3.0 version is the add power. As expected, the 4.0 includes a 4.00D add, which yields a 3.20D add at the spectacle plane. The 3.00D add will yield a 2.50D add at the spectacle plane (figure 1). In studies, 81% of patients reported being free of glasses completely with the 3.0 lens.⁴

1. This binocular defocus curve demonstrates the differences between the Acrysof ReStor 4.0 and 3.0 Multifocal IOLs. Both have a focus of light at plano, but the 3.0 has its second focus at 2.50D and less of a drop off in the intermediate range, resulting in improved intermediate vision.

Patients should experience good distance and near vision with these lenses. In a study comparing the 3.0 to the 4.0, 88.1% of patients saw 20/25 with the 3.0, and 88.4% of 4.0 patients saw 20/25 at distance without correction. Distance corrected near vision was 20/25 for 82.1% of 3.0 patients and 72.8% of 4.0 patients. But, intermediate vision is where the 3.0 lens outperforms the 4.0 lens. Research shows that 68.7% of patients see 20/25 with the 3.0 lens, and that 27.3% of patients see 20/25 with the 4.0 lens. Overall, 95% of patients indicate that they would have the same lens implanted again.⁴

The principle side effects of diffractive lenses are glare and halo, secondary to the two light foci within the eye. And, these lenses cause a reduction in contrast sensitivity as a result of the separation in light energy into the two bundles. When comparing the contrast sensitivity of the ReStor Multifocal and the Tecnis Multifocal to a monofocal control, there are measurable differences in contrast sensitivity between the two groups at higher spatial frequencies under both photopic and mesopic conditions. With diffractive optics, 41% of light energy is dispersed to the near image, and 41% of light energy is dispersed to the distance image. This leaves 18% of non- functional light.^5,6

Keep in mind that the human eye is not accustomed to processing multiple images, so it may take time for it to adapt to a diffractive lens. This process can take anywhere from weeks to a year. In a 16-site study, 67% of 159 patients with the ReZoom IOL reported an improvement in halo and glare between six weeks and six months.⁷

The incidence of dysphotopsias, however, differed drastically when patients were directly asked about it (20% to 77%) or asked to self-report it in the event that they manifested (0.2% to 1.5%). It has been found that younger patients, patients without maculopathy and patients with better convergence are more likely to neuroadapt.^8,9

• The Crystalens HD. The Crystalens HD (Bausch & Lomb), the most recent version of the Crystalens, is a plate haptic IOL with several unique features. The haptic on the lens acts as a “hinge” to allow the lens to move slightly forward and flex secondary to vitreous pressure during accommodation (figure 2). The optic of the lens moves forward with the contraction of the ciliary muscle through an increase in vitreous cavity pressure. Also, the lens “arches” centrally, which increases negative spherical aberrations and coma (figure 3). Additionally, the central asphericity of the Crystalens HD increases depth of focus, providing improved near vision.

2. The haptic allows the Crystalens HD (Bausch & Lomb) to move slightly forward and to flex in response to vitreous pressure.

3. When the Crystalens HD (Bausch & Lomb) flexes, it arches centrally, increasing negative spherical aberration and coma.

Crystalens HD patients experience good distance vision after surgery—in one study, 91.9% of patients demonstrated uncorrected visual acuity of 20/25 bilaterally.¹⁰ At 40cm, 72.6% of patients saw 20/25 or better bilaterally, and at 80cm, 98.4% of patients saw 20/25 or better. When the successive versions of the Crystalens are compared (4.5, 5.0 and HD), the wearer notices consistent distance and intermediate vision and gradual improvements in near vision.¹⁰

In order to achieve a “flexing” of the lens, it must sit completely pos- terior within the capsular bag. If it sits differently, the distance prescription may be impacted, and also, the lens may not move forward enough to achieve good near vision.

Patients’ Selections

These options can be confusing to patients, but it is important that they are aware of the lenses available. Steven Dell, M.D., has developed a survey to help patients understand that none of the lenses can provide “everything” (figure 4).

4. Developed by Steven Dell, M.D., the Dell Survey can be an effective tool to determine what type of vision (near, intermediate or distance) is most important to each patient.

This tool, or something like it, can help patients understand if their day-to-day lives require more distance, intermediate or near vision. The survey also helps you understand which patients are more or less likely to neuroadapt to multifocal IOLs. Such tools can help direct the conversation with cataract surgery patients about premium IOLs.

Several factors determine the IOL that best suits each patient. These include the patient’s age, occupation, hobbies, daily activities, pupil size and retinal health.

Both diffractive lenses, the ReStor Multifocal and the Tecnis Multifocal, reduce the patient’s contrast sensitivity.^6,11 Contrast sensitivity is also reduced as a result of macular degeneration, macular edema from diabetes and advancing glaucoma. The combination of retinal problems and reduced quality of vision from a diffractive lens may result in vision that is intolerable for the patient. Another condition with which to consider the chance of reduced contrast sensitivity: radial or astigmatic keratectomy. Patients who had such a procedure, as well as those with retinal problems, may do better with the Crystalens HD because it does not reduce contrast sensitivity.

Pupil size is also important to consider. Patients with very small pupils (less than 3.5mm) may not benefit from the full effect of the diffractive optics, and those patients with large pupils (greater than 7mm) may have increased glare and halo when implanted with diffractive lenses.

Because these patients are paying a premium for these lenses, their demands for high-quality vision can be greater than those of the “average” cataract patient.

We have discussed the limitations of patients with retinal issues, but the tear layer can also affect vision. Evaluating the tear layer should be part of the normal preoperative evaluation. When necessary, treating ocular surface disease before surgery improves the quality of vision after surgery.¹² That treatment can include artificial tears, cyclosporine, hot compresses, fish oil pills and punctal occlusion.

A patient’s motivation to be free of glasses is also an important factor to evaluate. Some patients are very happy with glasses and are almost fearful to be without them. While spectacle dependence is minimized with all premium IOLs, complete independence cannot be expected with any of them, and none of the lenses accommodate as easily as a 25-year-old’s eye.

It is crucial to counsel patients as to the strengths and limitations of the different options. In general, patients who prefer close vision over intermediate vision will be happier with a diffractive lens. Those who are concerned about glare and are willing to use reading glasses as needed will be happier with Crystalens HD. Of course, each patient needs to be treated individually.

Patient Considerations

There are several statements and questions that are important to communicate with a patient who is considering a presbyopic IOL. Document this conversation in the patient’s record in your own hand in order to decrease your liability through clarifying and creating a record of the conversation.¹³ If you are considering a diffractive IOL, always ask the patient, “Will you be okay with glare at night?” This question is very specific and direct. Not that all patients with these lenses are permanently troubled by glare at night; but, they all must understand that they will experience glare early on and possibly forever. Most patients will probably respond with something to the effect of, “I have so much glare now! If I could just see more clearly and read, I would be happy.”

What I have found by asking this question of every patient is that occasionally, a patient is very taken aback and alarmed. In such cases, I do not recommend a diffractive IOL.

As long as you are direct and upfront about the chance of glare at night, most patients throughout postsurgical follow-up comment that there is some glare, but that it has improved since surgery and–– most importantly––does not bother them at all.

Similarly, when considering the Crystalens HD, I always ask patients if they are willing to wear reading glasses for small print and close work. Again, most patients find this to be perfectly fine. On a rare occasion, patients may indicate that they do not want to wear glasses at all if they are going to pay more for the premium IOL.

Warn this patient very clearly that there are no guarantees of surgical outcome. Though it may seem likely that currently available technology will not satisfy such patients, other factors may weigh more heavily in their decision—the desire to lessen dependence on glasses, for example.

It is key to ask each patient the same list of questions: glare, acceptability of glasses for near work, etc. You will find there is only a small subset of answers.

I presented my mother with all these questions and it became clear what lens would be best for her. More importantly, it led me to create a program in my practice called “Just Like My Mom,” in which every patient understands that he or she will be asked the same questions as my Mom, be given the same time as my Mom, and be managed exactly the same as my Mom—hopefully resulting in the same wonderful outcome my Mom experienced. By making time for each patient and handling each case with patience, you will create thoroughly informed patients who should be aware of and satisfied with the outcomes with today’s premium IOLs.

The 10 Commandments of Patient Communication About Premium IOLs By John A. Hovanesian, M.D.

Currently, nearly 75% of eligible cataract patients in our practice elect to have a premium IOL. Our unusually high conversion rate has been a direct result of our constant effort to improve the way we educate our patients preoperatively. The following “10 commandments” will contribute to your success in patient conversion, as they have with ours. I: Believe in the Technology. Through our experience and discussion with many happy patients, we have learned that we would eagerly recommend a premium implant to any close friend or family member. Every member of our staff has been extensively trained in the benefits of presbyopia correction and shares in this enthusiasm from his or her heart. If you have even a small reservation in recommending a premium lens, it will be apparent to your patient, and you may not be ready to manage the greater expectations these patients are likely to have with a premium product. To determine if you understand the details of the procedure and the product, meet with or talk to patients who have had the procedure; observe surgery and some patient follow-up visits to witness the patient response firsthand; go into surgery and observe the first patients you comanage; or ask a staff member with cataracts to consider the procedure to then better explain it to patients. II: Understand the Importance of the Discussion. Selecting an IOL is a life-changing decision for the patient, and the cost is high. If information is presented too quickly, the patient, confronted with the stress of such a decision (a frightening upcoming surgery, in his or her perspective), may just opt out by default. In such situations, many simply give up and say, “I don’t mind wearing glasses. I’ve done it all my life.” For this reason, do not begin the discussion by asking whether the patient is interested in a premium implant. Instead, take the time to explain the benefits of a high-tech lens in understandable terms to every single patient. Schedule extra time for this discussion for patients who may be ready for cataract surgery. III: Match the Technology to the Patient. We ask each patient to fill out a questionnaire that rates his or her visual disability and determines his or her needs for distance, intermediate and near vision. We also rely heavily on recommendations from the primary care optometrist, who has been managing this patient for the past several years. If you are working with a surgeon who uses more than one type of premium implant, make a recommendation to the surgeon as to which lens you think would best fit the patient. An 80-year-old who spends most of her time watching television and reading the Bible might be a better candidate for a multifocal IOL, such as ReStor or ReZoom, while another patient who uses a computer and drives after dark is probably be better served by an accommodative IOL, such as Crystalens HD. Patients who have had monovision may do very well with an accommodative implant, but also do very well with monovision IOL combination targeting one eye for distance and one eye for near. IV: You Do the Educating. Use several educational tools. We always have multiple brochures, videos and consent forms—not to mention our website—that are always available to patients before their consultation. But, the first verbal discussion about IOL choices—and thus the burden of proper, thorough education—is with the doctor. This is the portion of the process that ensures reasonable expectations and requires you to customize the education process to the patient’s needs. Such vital information must come from the most trusted source—the doctor. V: Keep It Simple. Rather than presenting IOLs by name and brand to patients, make an individual recommendation. We like to say, “There’s a new standard in cataract lens implants that has been emerging during the past five years—to use a ‘high-tech’ implant designed to correct not only your cataract, but also your vision. These implants cannot guarantee a life without glasses, but they’re designed to give you a much better ability to drive and read without glasses.” This way, we speak in terms of activities, rather than Snellen acuity. Instead of mentioning distance, intermediate and near vision, we talk about driving (including at night), seeing the computer (or the dashboard, grocery aisle, sheet music or mobile phone) and looking at the newspaper (stock page, crossword, sewing, etc.). Patients appreciate this context, and they may receive your message a little more clearly because you’re using terms and practices that they are more likely to understand and apply in their daily lives. VI: Know the Technologies. With the availability of technical information online, patients are more frequently asking specific questions about lenses and technologies. To be an effective educator, you must thoroughly know not only the technology that he or she recommends, but others as well. Patients appreciate a candid comparison. If you don’t explain it, patients will think you are not aware of these new technologies. VII: Enhancement Needed? No Charge. Work with surgeons who offer excimer laser or piggyback IOL enhancements at no charge, when needed. This, along with clear, upfront communication about the procedure and outcome, ensures that your patient will be satisfied with the result and that he or she is prepared in the event of a refractive “surprise.” But, it may not be best to mention the availability of no-charge enhancements before cataract surgery. Enhancements are generally needed in less than 10% of cases, and some patients may request enhancement when it is not necessary, putting you in the uncomfortable position of having to explain why you are withholding something you had previously dubbed an “entitlement.” VIII: Be Clear About Limitations. We always tell patients, “Don’t expect perfect. If you compare what you have to perfect, you’ll be disappointed—whether you’re talking about your lens implant, your car, your computer or your spouse.” If you compare vision with a premium IOL to that with an older implant, the difference is huge. Many people can pass a driver’s test without glasses, but they may need glasses to feel comfortable reading road signs at night. Likewise, many people can read a newspaper, but if they’re going to read it cover-to-cover, they might prefer to wear reading glasses. Tell patients to expect to need glasses for some things, like prolonged reading or reading of fine print. IX: Be Clear About Extra Costs. Patients need to know the approximate cost of their lens choices and that financing is available. Patients should also understand that nearly everyone wants a high-tech lens, but not everyone can afford it. We explain: “The good news is that the biggest costs are covered by your insurance, including the operating room, anesthesia fees, fees for surgery, nursing and supplies. All those add up to about (such an amount) per eye, which is covered by insurance. Adding a high-tech implant adds about (such an amount) per eye that is not covered by any insurance. It’s optional. Our staff can tell you about financing options that make it as affordable as a few dollars a day.” X: What Would You Do for Your Mother? It’s important for the patient to understand that even though the benefits of a premium, presbyopia-correcting implant are greater, he or she will still be happy with a standard monofocal lens. Patients appreciate hearing about how you would take care of your family members in this situation, and they are comforted by the knowledge that they are being given this level of care. Dr. Hovanesian is a clinical instructor at the UCLA Jules Stein Eye Institute and is in private practice in Laguna Hills, Calif., with Harvard Eye Associates. He specializes in refractive and lens implant surgery, cornea and external disease.

Dr. Owen graduated from the Illinois College of Optometry and received his MBA from San Diego State University. He is a Fellow of the American Academy of Optometry and is the current President of the Optometric Council for Refractive Technology. He has a private practice in Encinitas, Calif.

References

1. Mendicute J, Irigoyen C, Aramberri J, et al. Foldable toric intraocular lens for astigmatism correction in cataract patients. J Cataract Refract Surg. 2008 Apr;34(4):601-7.
2. Abbott Medical Optics, Inc. TECNIS Multifocal Foldable Acrylic Intraocular Lens package insert. Santa Ana, Calif.
3. Cillino S, Casuccio A, Di Pace F, et al. One-year outcomes with new-generation multifocal intraocular lenses. Ophthalmology. 2008 Sep;115(9):1508-16.
4. Alcon Labs. Acrysof IQ ReSTOR SN6AD1 package insert. Fort Worth, Tex.
5. Ravalico G, Parentin F, Sirotti P, Baccara F. Analysis of light energy distribution by multifocal intraocular lenses through an experimental optical model. J Cataract Refract Surg. 1998 May;24(5):647-52.
6. Palmer A, Faina P, Albelda A, et al. Visual function with bilateral implantation of monofocal and multifocal intraocular lenses: a prospective, randomized, controlled clinical trial. J Refract Surg. 2008 Mar;24(3):257-64.
7. Pepin SM. Neuroadaptation of presbyopia-correcting intraocular lenses. Curr Opin Ophthalmol. 2008 Jan;19(1):10-2.
8. Aslam T, Gupta M, Gilmour D, et al. Long-term prevalence of pseudophakic photic phenomena. Am J Ophthalmol. 2007 Mar;143(3):522-4.
9. Davison J. Positive and negative dysphotopsia in patients with acrylic intraocular lenses. J Cat Refract Surg. 2000 Sep;26(9):1346-55.
10. Bausch & Lomb. Crystalens HD package insert. Rochester, N.Y.
11. Hofmann T, Zuberbuhler B, Cervino A, et al. Retinal straylight and complaint scores 18 months after implantation of the AcrySof monofocal and ReSTOR diffractive intraocular lenses. J Refract Surg. 2009 Jun;25(6):485-92.
12. Donnenfeld ED, Roberts CW, Perry HD, et al. Efficacy of topical cyclosporine versus tears for improving visual outcomes following multifocal intraocular lens (IOL) implantation. Presented at: 79th Annual Meeting of the Association for Research in Vision and Ophthalmology; May 6-10, 2007; Fort Lauderdale, FL.
13. Personal conversation with John Potter, O.D., F.A.A.O. February 2009.