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  • Working to Make the Premium IOL Patient Happy

    By Lori Baker Schena, Contributing Writer

    This article is from February 2009 and may contain outdated material.

    Though relatively small in number, the cataract patients who choose a premium IOL and find themselves unhappy with the visual result can be very vocal. Use these pre- and postoperative strategies to help optimize their outcome.

    Without a doubt, one inevitability in the life of an eye surgeon is the unhappy patient. “No matter how experienced you are, no matter how careful you are, and despite your best efforts, there will always be a small but vocal group of patients who are simply not happy with their results,” observed Steven I. Rosenfeld, MD, who is in private practice in Delray Beach, Fla.

    One group of patients that is making its feelings known is what Dr. Rosenfeld terms “unhappy IOL patients,” specifically: unhappy premium IOL patients. From the physician’s office to the Internet, these patients are not shy about voicing their displeasure with the cataract surgery experience. “With all the new premium IOLs, the manufacturers will tell you that they have lots of happy patients,” Dr. Rosenfeld said. “They experience good distance, medium and near vision despite the hypothetical limitations of each lens. But there is still a group of patients that is not seeing clearly. This is in large part due to the reality that none of the lenses can do everything for every patient, a fact ophthalmologists must take seriously.”

    A Short History

    In the 24 years that Dr. Rosenfeld has been in practice, he has seen cataract surgery go through several advances, each with the expected hiccups that occur when new technology is intro duced. “Over the last few decades, cataract surgery had come to a point where we had reliable and reproducible results for distance vision,” he said. “Yet that wasn’t good enough. When the Baby Boomers, many of whom had LASIK, wanted the vision of a 20-year-old, the multifocal IOLs proved to be the answer.”

    First step. Dr. Rosenfeld recalls the introduction of AMO’s multifocal Array IOL, which the FDA approved in 1997, allowing patients to see both distance and near. While the lens represented a breakthrough, a sizable number of patients experienced visual side effects, including glare, halos and night vision complaints, and the lens was eventually taken off the market. But the expectation for multifocals had been set.

    Up and running. Fast-forward to 2004, when the FDA approved Bausch & Lomb’s Crystalens, followed a year later by the approval of Alcon’s AcrySof ReStor and AMO’s ReZoom lens. “A majority of my patients have been quite happy. Some admitted they had halos at night but were so pleased to experience near vision that they tolerated some of the side effects,” said Dr. Rosenfeld. Yet, from the start, he knew that there existed a small group of unhappy patients.

    Shortcomings of the Premium IOLs

    Each of the premium IOLs has shortcomings, which can lead to patient dissatisfaction. For example:

    • The Crystalens has flexible haptics that move the optic, so that when the eye accommodates and the ciliary muscle contracts, the optic vaults anteriorly and the patient can see at near. “The one drawback,” said Dr. Rosenfeld, “is that the near vision is variable because the ciliary muscle contraction isn’t as effective in some people. Consequently, the lens doesn’t move back and forth adequately, so they don’t read well.” The monofocal optic on the Crystalens, however, does not usually cause glare and halos, he said.
    • The ReStor multifocal lens features multiple concentric circles that alternately allow for distance and near vision. In his experience, Dr. Rosenfeld has found that this lens has three shortcomings. First, the design can contribute to glare and halos at night. Second, the intermediate vision can be inadequate. Third, the lens depends on neural adaptation. “Different people have different capabilities to neurally adapt to this lens,” Dr. Rosenfeld said. “And in this day and age, we have no way to predict who can successfully adapt with these lenses.”
    • The ReZoom also has shortcomings, said Dr. Rosenfeld. This second-generation multifocal lens distributes light over five optical zones to provide near and distance vision. In working with the lenses, Dr. Rosenfeld has found that patients who opt for this multifocal tend to have better intermediate vision than ReStor patients but not as good near vision. “In seniors, the pupil doesn’t tend to dilate efficiently in the dark. With the design of the ReZoom lens, if your pupil doesn’t dilate well, you won’t read well,” Dr. Rosenfeld explained. The ReZoom lens also seems to create more glare and halos than its competitors, he said.

    Both the ReStor and ReZoom multifocal IOLs distribute the incoming light to more than one focus on the retina. This decreases contrast sensitivity and increases glare disability because the image of a distinct focus is always overlapped by out-of-focus images generated by the multifocal principle, said Dr. Rosenfeld. The process of neural adaptation involves the brain learning to adapt to, or ignore, the simultaneous images.

    Virtual Voices on the Internet

    These shortcomings are resulting in some unhappy individuals. And these patients are not voicing their displeasure only in their doctor’s office. Thanks to the Web, their complaints are being widely disseminated. A few years ago, John C. Hagan III, MD, who is in private practice in Kansas City, Mo., stumbled across one particular site——that had an eye care section with a Q & A component. “I was shocked that the person answering patients’ questions was an optom etrist, and that the answers were poor or flat-out wrong,” said Dr. Hagan.

    Eye M.D. to the rescue. Incensed, Dr. Hagan took the matter into his own hands, contacting the Web site and volunteering to take over the Q & A. (In 2007, the Academy partnered with MedHelp to provide ophthalmologists to answer questions posted in the “Ask a Doctor” eye care forum and the “Eye Care Medical Support Community.”) For Dr. Hagan, the experience has been eye opening. He and his colleague, Michael J. Kutryb, MD, who is in private practice in Titusville, Fla., “were both impressed by the number of unhappy patients with multifocal implants.” He was so taken aback that he decided to conduct a retrospective study, which was published in the January/February Missouri Medicine. (Dr. Hagan is also the journal’s editor.)

    Identifying the problems. In their study, Drs. Hagan and Kutryb looked at all postings on the “Ask a Doctor” eye care forum and the eye care “Medical Support Community” on MedHelp from Nov. 1, 2007, to May 1, 2008, that dealt with cataract extraction/IOL implantation, convalescence and satisfaction/dissatisfaction. They reviewed 750 postings and analyzed 341 threads for causes of satisfaction or dissatisfaction. While not controlled, the study findings showed that common complaints involved unwanted visual aberrations, night blind ness, blurred vision, pain and dependence on glasses. When the writer specified the IOL type, there were more adverse comments about multifocal IOLs than monofocal IOLs. In addition, there were more complaints about ReZoom than the ReStor or Crystalens.

    Dr. Hagan noted the limitations of his study. In addition to its retrospective design, he said, “it deals with a population that is seeking help for problems. Happy patients aren’t trolling Internet Web sites.” Interestingly, older cataract surgery patients may be less inclined to use the Internet, thus skewing Dr. Hagan’s methodology toward a younger patient perhaps more inclined to opt for a multifocal IOL. Yet many of the postings were from children and grandchildren of surgical patients.

    “We made three conclusions from our study,” Dr. Hagan said. “First, most Internet eye care forum users complain about problems with their cataract/IOL surgery. And while multifocal patients make up only 10 percent of the cataract surgery population, the premium IOL patients posted a disproportionately large number of complaints, problems and disappointing outcomes.” Second, said Dr. Hagan, the study suggests that ophthalmologists must be up-front with their premium IOL patients regarding the postoperative possibility of spectacle dependence, difficulty with night vision and manifestations of dysphotopsia. Finally, he noted, “We believe that medicine, and ophthalmology in particular, needs to do more Internet-based studies, especially in terms of complications and unmet patient expectations,” Dr. Hagan said. “This is where things are moving, and we need to pay closer attention to eye health care forums.”

    Postop Strategies for Dissatisfed Patients

    Dr. Rosenfeld outlined seven steps to take when caring for unhappy patients.

    1. Residual refractive error. Refract the patient and look for residual error because it can cause blurry vision and dysphotopsias, including glare, halos and night vision complaints.

    2. Residual astigmatism. Perform corneal topography, which can pick up regular or irregular corneal astigmatism. This may require treatment with limbal relaxing incisions or laser vision correction.

    3. Ocular surface disease. Consider the ocular surface. “Dry eye and blepharitis after cataract surgery tends to make the quality of vision worse,” Dr. Rosenfeld said. Interestingly, patients with dry eyes can sometimes present with subtle or nonexistent symptoms, so the ocular surface must be checked.

    4. Posterior capsular opacification. “We have learned that patients with multifocal lenses are more sensitive to this condition,” he said. “And the postscript: If you have a patient who is unhappy and has mild posterior capsular opacification, you should consider doing a YAG laser capsulotomy. It is a very benign procedure for a common occurrence.”

    5. Poor IOL centration. Make sure the lens implant is properly centered, which is a key issue with all three lenses. “Sometimes just in the process of healing, the lens can shift a bit due to asymmetric contractile forces, causing distortion of vision,” Dr. Rosenfeld said.

    6. Maculopathy. There may be something going on with the retina. The ReZoom and ReStor lenses are associated with reduced contrast sensitivity, said Dr. Rosenfeld. Thus, if the patient has any type of maculopathy, such as macular degeneration, cystoid macular edema or a macular epiretinal membrane, which causes a loss of contrast sensitivity, a multifocal lens may be making a bad situation worse.

    Besides a thorough dilated fundus exam, Dr. Rosenfeld also recommends performing fluorescein angiography and/ or an OCT to better evaluate the macula. The OCT is very helpful in diagnosing patients with cystoid macular edema, and in documenting if the CME is improving. “OCT is also good at picking up macular epiretinal membranes, which may occur with aging, or following any intraocular surgery,” Dr. Rosenfeld said.

    7. Problems with neural adaptation. There are some patients who complain about their vision but don’t have any of these conditions. In that case, it may be problems with neural adaptation. “There is no way to stimulate neural adaptation,” Dr. Rosenfeld said, “leading to some frustrated patients.”

    Good history. Roger F. Steinert, MD, director of refractive, cornea and cataract surgery, and professor of ophthalmology and biomedical engineering at the University of California, Irvine, also has some advice to deal with the unhappy premium IOL patient. He recommended first taking a careful history—listening closely to the patient and asking nonleading questions—and examining the patient before and after dilation. “Words like ‘halo’ and ‘glare’ are confusing,” he said. “Your version is not necessarily your patient’s version.” Dr. Steinert often asks patients to bring in sketches of their problems to their office visit for clarification. Another key step is to figure out which eye is giving the patient problems, he said. While this sounds basic, some patients never actually place one hand to their face at home to determine which eye is giving them problems.

    One important question to ask is whether distance is satisfactory or a problem. If distance is satisfactory but intermediate or near is bad, this can be solved with glasses or custom matching the implant in the other eye, which leads to two key points. First, never promise zero use of glasses, said Dr. Steinert. Instead stress that the lenses reduce the amount of time the average patient uses glasses. Second, never rush to implant the second eye until the first eye checks out. “If there are any issues with the first eye, the second eye can be custom matched to the appropriate premium lens.” Dr. Steinert stressed: “Use the ‘go slow’ strategy.”

    Like Dr. Rosenfeld, he also recommended refracting to detect astigmatism and looking at ocular surface, tear film, macula, optic nerve and posterior capsule issues as well.

    Preop Strategies to Prevent Dissatisfaction

    Dr. Rosenfeld said that the most important step the ophthalmologist can take to avoid the unhappy IOL patient is to man age expectations. Thoroughly explaining the possible side effects is an excellent investment in time. “I tell ophthalmologists they should under-promise and over-deliver,” he said.

    Get the lay of the land. Another strategy that many surgeons find helpful is doing preoperative corneal topography. Once the domain of refractive surgeons, this diagnostic tool is being used increasingly for premium IOL cataract surgery patients.

    Parag A. Majmudar, MD, associate professor of ophthalmology at Rush University in Chicago, says the combination of advances in corneal topography have made this diagnostic tool an essential step in evaluating candidates for premium IOLs. “A vivid example is the patient who presents with keratoconus, which is a contraindication for multifocal and toric IOLs,” Dr. Majmudar pointed out. “You can save yourself the hassle and aggravation by detecting keratoconus up front.” Corneal topography also can be used to identify topography abnormalities that may preclude laser vision correction enhancements following premium IOL implantation.

    Robert J. Weinstock, MD, in private practice in Largo, Fla., agrees, pointing out that a cataract consult is becoming like a refractive surgery consult, especially in light of the new premium IOLs. About 10 years ago, surgical pioneers who were correcting astigmatism at the time of cataract surgery would use early topography machines prior to limbal relaxing incisions and toric implants. Now, corneal topography has proven useful in evaluating which premium lens would best benefit the patient.

    Dr. Weinstock contrasted past to present. “Traditional cataract surgery involved obtaining a rudimentary evaluation of the eye to obtain the minimum data for IOL selection.” These tests, included a single K-reading to determine the corneal curvature and an A-scan biometer to determine the axial length of the eye. “For years, this was considered the gold standard,” Dr. Weinstock said. “Now, with all the new options available, it is imperative to go above and beyond these simple tests.”

    Measure the eye from more than one angle. In Dr. Weinstock’s practice, patients receiving premium IOLs undergo several tests, including wavefront aberrometry, the IOLMaster, corneal topography and ultrasound. “We incorporate multiple formats to gather the data and identify any issues that need to be addressed,” he said. “We combine these data with the patients’ visual goals in making all decisions related to choice of IOL lens.”

    When the Patient Is Really Unhappy

    If someone is truly not happy with a premium IOL, and his or her condition is not t reatable, is it worth taking out the premium lens and exchanging it for a standard lens? “This is something that not every surgeon is comfortable with,” said Dr. Rosenfeld. “It is a technically more sophisticated procedure w ith greater risk. In addition, the longer a lens implant is left in place, the more difficult it is to remove.” This is a double-edged sword because while time is a factor in removing an IOL, it is also a factor in determining whether the patient will improve because of neural adaptation.

    The best thing a surgeon can do in the first place is listen to the needs of their patients, and implant the appropriate premium IOL. For example, Dr. Rosenfeld said, a patient who works on a computer and thus needs good intermediate vision may be best served by the accommodative Crystalens. He added that the ReZoom is also an alternative because it offers better intermediate than near vision. “But the patient who has strict near demands—someone who does needlepoint or collects coins—would be better served with the ReStor, factors that a surgeon cannot determine unless he or she takes the time to listen,” he said.

    Meet the Experts

    In private practice at Discover Vision in Kansas City, Mo.
    Financial disclosure: None.

    Associate professor of ophthalmology at Rush University in Chicago.
    Financial disclosure: Consultant to Alcon, Allergan, AMO, Inspire and IOP Inc., but reports no financial interests in any product discussed in this article.

    Voluntary associate professor of ophthalmology at Bascom Palmer Eye Institute in Miami and in private practice at Delray Eye Associates in Delray Beach, Fla.
    Financial disclosure: Speaker for Allergan.

    Professor of ophthalmology and biomedical engineering, and director of refractive, cornea and cataract surgery at the University of California, Irvine.
    Financial disclosure: Consultant to AMO, LenSx, ReVision Optics and Rhein Medical.

    In private practice and director of cataract and refractive surgery at the Eye Institute of West Florida in Largo.
    Financial disclosure: Consultant to Bausch & Lomb.