Symposium: Presbyopic IOLs: Do you really know what your patients want?

Stephen G. Slade, MD: Cataracts are the leading cause of vision loss worldwide. Patients with cataracts often choose IOL implantation after discussing treatment options with physicians. Accommodative IOLs are attractive to patients because they improve all ranges of vision, unlike other IOLs that cannot improve all ranges. In addition, accommodative IOLs use a monofocal optic, which can reduce the risk of glare and halos.

What is accommodation, and how do surgeons explain loss of accommodation to patients?

“When describing loss of accommodation, I use the term dysfunctional lens and explain how lenses become dysfunctional at about age 40 years.” — Harvey L. Carter, MD

Harvey L. Carter, MD: Accommodation is the dioptric adjustment of the crystalline lens to attain maximal sharpness of retinal imagery for an object of regard. Accommodation is the ability of the eye to afford clear imagery of a stimulus object over a range of distances.

I explain accommodation in simple terms that patients can understand. When describing loss of accommodation, I use the term dysfunctional lens and explain how lenses become dysfunctional at about age 40 years. The term “dysfunction” is commonly used by baby boomers, easily understood by patients and has become the politically correct way of explaining a number of age-related issues to this group of patients.

Slade: What is the mechanism of action of accommodative IOLs?

Michael Colvard, MD: Pseudophakic accommodation can be accomplished by several mechanisms. For further clarification, I find it helpful to use a classification of mechanisms suggested by Samuel Masket, MD.¹ Dr. Masket revealed the three basic IOL designs used by developers of accommodative IOLs: IOLs with flexible haptics that are designed to move forward with accommodative effort; IOLs with flexible optics that are designed to change in contour and increase in dioptric power with ciliary contraction; and IOLs that use dual optic systems and are designed to function like a Galilean telescope.

Focal Points of Premium Channel IOLs Figure 1. Unlike accommodative IOLs, such as the crystalens (eyeonics), multifocal IOLs, such as the ReSTOR (Alcon) or ReZoom (Advanced Medical Optics), present the retina with multiple images. Source: Waltz KL

The crystalens IOL (eyeonics) is the only accommodative IOL approved for clinical use by the FDA. The IOL is designed to move forward with accommodative effort, and recent wavefront studies suggest that some of its accommodative effect may also arise as a result of a change in lens contour with ciliary contraction.

The crystalens IOL provides a full range of visual function in a way that seems natural to patients. The amount of effective accommodation, however, varies from patient to patient. Some patients require reading glasses to see small print or to read in low levels of illumination, but the majority of crystalens patients are able to perform most of their daily activities without glasses.

Slade: What is the mechanism of action of the crystalens IOL?

Colvard: The crystalens provides an accommodative effect, but its mechanisms of action are not fully understood. The lens is designed to move forward with accommodative effort. Jack T. Holladay, MD, MSEE, FACS, suggests that the 4.5-mm optic of the crystalens IOL gives the crystalens IOL a greater depth of field than is seen with other IOLs.² In addition, Kevin L. Waltz, OD, MD, has presented wavefront data that suggests the crystalens, which is thin and more flexible than other IOLs, arches forward with ciliary contraction.³ Dr. Waltz believes that a central bowing forward of the lens in some patients results in a steepening of the anterior surface of the IOL, increasing accommodation.

Slade: How do multifocal or multi-image IOLs differ from accommodative IOL technology?

Colvard: Unlike accommodative technology, multifocal IOL technology is stationary and uses diffractive or refractive optics to present multiple foci to the retina. Multifocal IOLs can present the retina with either two images or multiple images, and the brain selects which images to view (Figure 1).

Patient needs key to IOL selection

Slade: Achieving optimal surgical outcomes with IOLs depends on careful patient selection. Surgeons should understand a patient’s preoperative lifestyle and postoperative expectations. How should surgeons present different lens replacement options to patients?

Colvard: The key element to success is to listen carefully to the needs of the patient. If ophthalmologists take time to understand the needs of the patient, then ophthalmologists will be able to suggest the presbyopic lens option or options that most closely match these needs.

“Achieving optimal surgical outcomes with IOLs depends on careful patient selection. Surgeons should understand a patient’s preoperative lifestyle and postoperative expectations.” — Stephen G. Slade, MD

I prefer to collect information regarding a patient’s lifestyle and activities before I begin discussing surgery or the options for presbyopia correction. Once I have this information, I begin the discussion by explaining the concept of lens exchange surgery. The majority of patients in my practice are cataract patients, so I begin with the basic explanation that a cataract is a cloudiness in the focusing lenses of the eye and that cataract surgery involves the removal of this cloudy lens and the implantation of a new, clear lens. I then explain that we are fortunate today because we have new options for the correction of vision — the standard monofocal IOL, which provides a single focus, and the new accommodative and multifocal IOLs, which have the potential to provide a youthful range of visual function without spectacles.

Slade: Which presbyopia-correcting IOLs do you use in your practice? How do you select which options are best for a particular patient, and how do you counsel patients on the available options?

Carter: I predominantly use the crystalens IOL for refractive lens exchange (RLE) and cataract upgrades. I have implanted the ReZoom IOL (Advanced Medical Optics [AMO]), but I am reluctant to use the ReSTOR IOL (Alcon) due to a high explant rate of this IOL in my community, which includes one ophthalmologist. Also, in my clinical experience, side effects of the multifocal IOLs, such as glare, halo, night-driving impairment and decreased contrast sensitivity, leave me reluctant to use multifocal IOLs for RLE except in patients with the high degrees of hyperopia.

“Understanding the lifestyle needs of a patient and desired ranges of vision is most important when counseling on which presbyopic IOL to choose.” — Harvey L. Carter, MD

Through an informed-consent conversation, I will specifically counsel the occasional patient who requests a specific multifocal IOL to expect to have side effects and clearly document the conversation in the patient’s chart. I am concerned that ophthalmologists may see multifocal IOL side effect issues come up as malpractice litigation in the future just as ophthalmologists have seen in some of the LASIK litigation cases and verdicts.

Understanding the lifestyle needs of a patient and desired ranges of vision is most important when counseling on which presbyopic IOL to choose. I use the Steven J. Dell, MD, questionnaire to help determine what zones of vision the patient will tolerate (Figure 2). The questionnaire also serves as a framework for a discussion of realistic expectations regarding the capabilities of the different IOLs.

J. Trevor Woodhams, MD, FAAO: I primarily use the crystalens IOL. I also use the AcrySof ReSTOR IOL as an adjunct to the crystalens IOL.

Many of my patients come to me for LASIK, not cataract surgery. I counsel patients on the benefits of lens-based surgery, as opposed to LASIK. I am uncomfortable performing LASIK on patients older than 55 years, and I will not perform LASIK on patients older than 60 years. I review a patient’s age; any activities requiring sight for distance, intermediate, and near vision; sharpness; acuity; and functioning in low-light situations. These factors help determine whether monovision would be appropriate, which is infrequent in my practice, and whether to use an accommodative or multifocal IOL.

Figure 2. The Steven J. Dell, MD questionnaire assists ophthalmologists in determining the treatment best suited for a patient based on the patient's visual needs. Source: Dell SJ

Colvard: I implant the crystalens IOL in approximately 70% of patients who elect to have presbyopia correction and ReSTOR or ReZoom IOLs in the remaining patients.

Patient vocation, avocation and lifestyle are the primary factors I use to counsel patients when choosing a presbyopic IOL. Most important, I am interested in night-driving habits and vocational needs. Ophthalmologists must understand patient activities to help guide the decision-making process. Although many factors should be considered, I tend to guide the patients whose lifestyles require a high level of visual quality toward the crystalens and the patients for whom reading entirely without glasses is of highest priority toward the ReSTOR IOL or a combination of ReZoom and ReSTOR IOLs.

Kevin L. Waltz, OD, MD: The presbyopia-correcting IOLs I use in my practice are the crystalens, ReSTOR, ReZoom and Array (AMO) IOLs. I use a matched set of these lenses as well as mix and match the IOLs for specific patients, which allows me to treat extreme myopes and piggyback over a monofocal IOL.

I choose the IOL system to treat a patient based on preoperative Tracey wavefront at distance and near, patient’s age, refractive error and specific patient needs. The Tracey wavefront provides a good estimate of a patient’s historical exposure to higher-order aberrations (HOA) and a patient’s tolerances for HOAs postoperatively. A patient’s age provides an estimate of presbyopia and spherical aberration as an indication of severity of the preoperative symptoms. A patient’s habitual refractive error is a direct measure of preoperative lower-order aberrations. Specific patient needs provide a unique perspective of each patient’s visual demands.

The goal of my preoperative counseling is to determine the patient’s tolerance for HOAs postoperatively. The greater a patient’s tolerance of postoperative HOAs, the more likely I am to use a multifocal IOL. The less tolerant a patient is to postoperative HOAs, the more likely I am to use an accommodating IOL.

Improved accommodation

Slade: The crystalens IOL has a small focal area that can produce a significant amount of accommodation. How long does accommodation last with the crystalens IOL?

Woodhams: A widespread misconception is that once the capsule contracts and fibrosis occurs, the effect of the crystalens IOL will disappear. My experience, however, does not show that the effect disappears. Changes in vision occur with the increasing hardness of the capsule, but accommodation does not change. Once YAG capsulotomy is performed, a patient has the same amount of accommodation immediately postoperatively.

Slade: In the FDA trial of the crystalens IOL, accommodation improved over time (Figure 3). If a patient had a YAG capsulotomy, accommodation improved.⁴

Binocular uncorrected near visual acuity post-crystalens IOL implantation Monocular intermediate visual acuity through the distance correction post-crystalens IOL implantation Binocular uncorrected distance visual acuity post-crystalens IOL implantation Figure 3 Source: eyeonics

Woodhams: It is important for ophthalmologists to remember that a patient’s lens, not the ciliary muscle, loses the ability to function. Lens rigidity is the problem. The muscles can work fine with exercise.

Colvard: Two discoveries in the original FDA clinical study were that elderly patients achieve a significant accommodative effect with the crystalens, and that accommodation improves over time. The findings suggest that the ciliary muscle is still able to function effectively, even if a patient has been without useful accommodation for many years. In my experience, patients’ near vision is better at 2 months than at 2 weeks, and patients’ vision continues to improve for up to 1 year.

The improvement in vision, however, occurs only if patients exercise their accommodation. Paul Koch, MD, has created a series of puzzle workbooks that are designed for use by patients after crystalens IOL implantation. The workbooks stimulate accommodation and help patients to improve their reading vision without glasses.

Slade: The crystalens IOL is similar in action to the natural lens and has a dynamic quality that can increase accommodation with time.

How does the ReZoom IOL function?

“In presbyopic IOL exchange, I prefer to implant the crystalens IOL in the dominant eye and a ReSTOR IOL in the nondominant eye.” — J. Trevor Woodhams, MD, FAAO

Carter: As with any multifocal IOL, the ReZoom IOL breaks down and separates rays of light. The ReZoom IOL, like all multifocal IOLs, however, is optically limited in the ways light can be broken down and separated, leading to a bimodal distribution of where the light rays will focus. The strength of the ReZoom IOL is distance vision. In my clinical opinion, with only 17% of the light rays dedicated to intermediate vision, the ReZoom IOL may not deliver for computer distance vision. The 3.5 D add at the IOL plane provides for fairly good near vision.

Slade: Another multifocal IOL option is the ReSTOR IOL. What is your experience with the ReSTOR IOL?

Woodhams: The ReSTOR IOL is an excellent IOL that provides significant magnification. Many patients spend 10 to 15 years gradually holding reading materials farther away. By the time a patient is 55 years old, with 55 to 60 years being the typical age range for presbyopic IOL exchange, the patient is holding reading materials at 14 to 20 inches away from his or her eyes. After ReSTOR IOL implantation set at +0.25 D to +0.5 D, a patient has near vision of 9 to 10 inches. In my clinical opinion, however, the ReSTOR IOL does not provide a significant increase in intermediate vision.

Slade: Which patients are implanted with the ReSTOR IOL in your practice?

Woodhams: I have a different approach than most ophthalmologists. In presbyopic IOL exchange, I prefer to implant the crystalens IOL in the dominant eye and a ReSTOR IOL in the nondominant eye (Figure 4).

Binocular uncorrected acuity crystalens-ReSTOR 3 months postoperatively Binocular Uncorrected Visual Acuity crystalens-ReStor Figure 4. Vision improved with the crystalens IOL implanted in the dominant eye and the ReSTOR IOL implanted in the nondominant eye. Source: Woodhams JT

crystalens IOL capabilities

Slade: What are the visual quality capabilities of the crystalens IOL, and how do they compare with the capabilities of the ReZoom and ReSTOR IOLs?

John F. Doane, MD: The crystalens IOL provides high-quality distance vision, excellent intermediate vision, and good near vision. The crystalens IOL is not ideal for every patient, however. ReZoom and ReSTOR IOLs may be superior in quantity of near vision; however, I believe they lack quantity of intermediate vision that the crystalens provides. I also believe distance vision with ReZoom and ReSTOR IOLs is slightly less when compared with the crystalens IOL.

Slade: With the crystalens IOL, some ophthalmologists aim for the nondominant eye to be slightly myopic. What is the ideal final refraction in the nondominant eye?

Doane: The ideal final refraction in the non-dominant eye is patient dependent. Patients perform best overall if one eye is slightly myopic, -0.5 D, and the alternate eye is plano. If the distance eye is plano to -0.25 D and the nondominant eye is -0.5 D, the overall visual function at near, intermediate and distance is maximized. Some patients, however, cannot tolerate the discrepancy between eyes despite being J1 at near and 20/25 at distance in the myopic eye. If the patient cannot tolerate the discrepancy, then enhancement surgery to put the myopic eye at a plano refraction will be required.

Carter: With the crystalens IOL, I prefer to aim in the nondominant near eye between -0.5 D and -1 D, but I would stress that the ideal final refraction is patient dependent. In the dominant distance eye, I aim for a target of -0.25 D.

Patient satisfaction

Slade: What feedback have you received from patients with crystalens IOL implants?

Woodhams: Feedback from patients depends on the severity of a patient’s condition prior to IOL replacements. Patients who have +3 D, +4 D and +5 D of hyperopia are impressed. They have near vision to a degree they probably did not have for decades. Distance vision, which they often thought was good, is much better than it was prior to surgery. Patients who have -10 D will also be impressed, but only with distance vision. Patients with low degrees of myopia, such as -2 D, are not as satisfied as other patients. A patient with a low degree of myopia bilaterally will often be disappointed with near vision results after IOL implantation. Ophthalmologists must prepare patients for that disappointment.

Slade: Ophthalmologists regard patients with low degrees of myopia as less satisfactory candidates for IOL implantation than plano patients with presbyopia.

Woodhams: Surgeons must explain to patients in no uncertain terms that the reason they have near vision is not because they do not have presbyopia, but because they have magnification due to myopia.

Slade: Discuss the incidence of glare, halos and night-vision problems with the crystalens IOL and other IOLs.

Colvard: Incidence of glare, halos and night-vision problems with the crystalens seems similar in LASIK patients and in patients with standard monofocal IOLs. Visual aberrations are seldom a problem with the crystalens. When visual aberrations do occur, they seem to be caused primarily by defocus. A patient with a refractive error is more likely to notice visual aberrations than a patient who is emmetropic.

Doane: With any IOL implantation, issues of dysphotopsia may arise; however, with the crystalens IOL, dysphotopsia is rare. Of the 600 implants I have performed, I explanted IOLs from one patient due to dysphotopsia. The incidence is low. The few patients who have symptoms of dysphotopsia are not disabled from any type of work functions.

Slade: What has been your experience with explantation of the ReZoom and ReSTOR IOL due to contrast sensitivity?

Doane: I have limited experience with the ReZoom and ReSTOR IOLs. One patient had the ReSTOR IOL implanted in one eye and the ReZoom IOL implanted in the other eye. The patient preferred the ReSTOR IOL and demanded the explantation of the ReZoom IOL. After exchanging the ReZoom IOL with the ReSTOR IOL, the patient is satisfied.

I have treated other patients with the ReZoom IOL, and they are satisfied with the results. I believe the tolerance of dysphotopsia is a patient-specific circumstance that can be difficult to predict.

Slade: Some patients adapt to the halos and dysphotopsia over time. The phenomenon is called neural adaptation. Is neural adaptation real, and, if so, how are patients adapting? Discuss neural adaptation with the crystalens IOL compared with multifocal IOLs.

Waltz: I am convinced neural adaptation is a real phenomenon that is age-related. Teenage patients who were implanted with a multifocal or accommodating IOL do not complain of unwanted visual sensations because the brain eliminates them; however, older patients do complain of unwanted visual sensations.

Human cognitive function peaks at about age 25. At 25 to 30 years, cognitive function in humans begins to deteriorate. When a person wakes up in the morning, vision is not sharp. Vision becomes sharper over the next half-hour to hour for a variety of reasons, one of which is neural adaptation. The crystalens IOL has a unique advantage over other IOLs because it requires less neural adaptation.

Learning curves, challenges

Slade: Is there a learning curve in implanting the crystalens IOL?

Carter: The learning curve with implanting a crystalens IOL is relatively short. The crystalens IOL platform itself is different from all other IOLs that the typical surgeon used before, and certainly the movement, flexibility and dynamic nature of the IOL implant are new and challenging for the beginning surgeon.

Doane: One factor that maximizes control when implanting the crystalens IOL is selection of the viscoelastic device. The crystalens is flexible at the hinges, and I have found a cohesive viscoelastic device will provide a highly controlled delivery environment. With a cohesive viscoelastic device, it is as if the IOL is held in suspension compared with trying to implant it under a thin, noncohesive viscoelastic device. The viscoelastic will help the beginning surgeon with the crystalens.

Slade: What are the surgical challenges involved with implanting the crystalens IOL?

Colvard: The size of the capsulorrhexis with the crystalens IOL is important. If the capsulorrhexis is too large, the IOL tends to vault forward. If the capsulorrhexis is too small, however, implantation is difficult. Also, the IOL is flexible, and placement of the IOL within the capsular bag must be performed carefully. Ophthalmologists must ensure that the IOL is placed symmetrically within the bag.

In addition, the incision must be tightly sealed, because any loss of chamber volume postoperatively can result in a forward movement of the IOL, which can lead to an anterior vault of the crystalens and postoperative myopia. Postoperative loss of chamber volume can be avoided by putting a single suture in all patients.

Slade: How does lens orientation affect clinical outcomes?

Waltz: I conducted a number of wavefront studies and observed distance and accommodative wavefront preoperatively.⁵ I used information from the studies to orient the crystalens IOL at certain angles relative to the preoperative information. Using the preoperative information to orient the IOL decreases the variability in outcomes when using the crystalens IOL.

Some ophthalmologists prefer automatically placing the crystalens IOL vertically, some prefer automatically placing the IOL horizontally and some ophthalmologists place the IOL randomly. If one eye has a better axis than the other and an ophthalmologist places the crystalens IOL randomly, then some of the results will be randomized. Ophthalmologists should try to detect the optimal axis preoperatively.

Recently, Richard L. Lindstrom, MD, suggested placing the crystalens IOL along the axis of greatest coma. Observing the amount of coma in the distance wavefront and placing the IOL along that axis may provide more consistent outcomes with the crystalens IOL.

Complication management

Slade: What complications did you encounter when first implanting the crystalens IOL, and what complications do you observe now?

Waltz: My initial start-up complications with the crystalens IOL were related to challenges with wound control. Many surgeons have never performed scleral incisions and are not comfortable touching the sclera. A scleral incision is not a good option for surgeons uncomfortable with the sclera. Some surgeons view placing a suture somewhat negatively. I, too, had a negative view of sutures, although I am comfortable working with the sclera. I performed scleral incisions in my first 10 IOL implantations and had leaks with all of them and unpredictable refractive outcomes.

I returned to a clear corneal incision and put in sutures, and my refractive outcomes significantly improved. I am amazed at how much my refractive outcomes improved. The presumption is that my incisions were leaking more than I thought. The number one thing that helped me going forward was accepting that I had to suture a clear corneal incision.

Woodhams: When first implanting the crystalens IOL, I found managing the capsule and ensuring that the IOL was within the capsule were more critical than usual. With the original crystalens, I had a few early cases of capsular contraction syndrome (CCS), which is marked by an asymmetrical vault of the IOL. CCS was a hurdle of the original crystalens, with symptoms occurring 1 to 7 months postoperatively and including a gradual myopic shift in refraction.

One case concerned a patient who had 20/20 vision on the first day and was extremely pleased. When she came back for the 1-week visit, I dilated her eye and the IOL popped into a Z position, and I had to reposition it. The problems did not reoccur after I learned how to handle the capsule, the importance of IOL positioning and how to ensure that the IOL was within the bag and symmetric.

Doane: Capsular fibrosis occurs with all patients and with all IOLs, but it can be significant when an IOL moves inside the eye. If capsular contraction moves the IOL, which is CCS with the crystalens IOL, a patient will not experience positive long-term results. With time, a patient will have myopia and astigmatism with decreasing distance vision but improved near vision.

The incidence of CCS decreased when ophthalmologists created larger capsulorrhexis sizes. A smaller capsulorrhexis leaves a high number of lens epithelial cells, which induce fibrotic reaction and metaplasia of the cells that leads to anterior displacement of an IOL. The introduction of square-edge technology, such as with the crystalens SE IOL (eyonics), also contributes to a decrease in CCS.

Carter: The complication I saw when first implanting the crystalens IOL was CCS. Now, with the crystalens SE design, this complication is rare, and I have seen lower capsule opacification rates. As a problem, CCS is remote now.

“Capsular contraction syndrome was my first complication with the first-generation crystalens IOL; however, that complication has been overcome.” — John F. Doane, MD

Management of patients with the crystalens IOL has become easier. Complication management begins with a meticulous surgical procedure. I always use a scleral tunnel to obtain a water-tight, sealed wound. I try to make a consistent same-size capsulorrhexis. I am meticulous about cortex removal and rotation of the IOL as well as astigmatism control at the time of surgery. These procedures significantly reduce complications and increase postoperative patient satisfaction.

Doane: CCS was my first complication with the first-generation crystalens IOL; however, that complication has been resolved. I would conjecture that the majority of the asymmetric vaults were controlled by specific YAG capsulotomy techniques.

Carter: I agree. In my practice, I have performed more than 1,200 cryatalens IOL implantations, and I have never had to explant a crystalens IOL because of CCS. I have been able to treat all patients who had CCS with a selective YAG capsulotomy. A number of patients who had CCS and were being prepared for IOL explantation were referred to my practice for YAG capsulotomy, and none of these IOLs have been explanted either. Explantation for CCS should be rare or nonexistent, and I believe that surgeons experienced in selective YAG capsulotomy can successfully treat CCS.

Colvard: The modified edge of the new crystalens SE IOL seems to have had a significant effect on reducing the incidence of posterior capsular opacification. Dr. Koch and I are in the process of conducting a 3-year prospective study of the incidence of capsular opacification with the crystalens SE. At the end of 1 year, neither of us has performed capsulotomies in any of the 125 patients in the study. In contrast, the incidence of YAG capsulotomies in the FDA study of the original crystalens IOL design was 30% in the first year.

Slade: Complication management also includes managing astigmatism. Should ophthalmologists treat astigmatism postoperatively or at the time of surgery?

Colvard: I prefer to correct low to moderate amounts of astigmatism with limbal relaxing incisions at the time of surgery. Patients with high levels of astigmatism benefit from bioptics. If the ophthalmologist can anticipate that a patient will need laser correction for an astigmatic error, then creating a flap before the lens procedure can be helpful. In this way, ophthalmologists can make the astigmatic correction earlier rather than later.

Waltz: I believe an ophthalmologist should treat the cylinder when the flap is created. Ophthalmologists should not wait until after the cataract surgery is completed. When creating the flap prior to cataract surgery, an ophthalmologist is guaranteeing cataract surgery, intraoperative surgery and surgery for astigmatism, and a patient may need an enhancement later. The result is four surgeries per eye. If an ophthalmologist treats the cylinder at the time the initial flap is created, then implanting the IOL is easier. Patients will be satisfied, especially if they were hyperopic and some of the hyperopic cylinder is removed.

Slade: How does an ophthalmologist decide when to perform a YAG capsulotomy?

Colvard: Most ophthalmologists perform a YAG capsulotomy to improve vision when there is opacification, or when asymmetric contractual forces lead to CCS.

Woodhams: I have a different thought on the need and desirability of YAG capsulotomy. I conducted a study using modulation transfer function (MTF) analysis, confirmed by subjective and objective measurements of vision, on patients who had routine ±20/20 vision on 100% contrast logMAR charts. The subjective improvement in near and distance vision was impressive, although improvement on logMAR charts was minimal to nonexistent. Are the results the placebo effect? The MTF measurements suggest that results are not due to the placebo effect, because function for patients significantly improved (Figure 5).

Modulation Transfer Function of Premium Channel IOLs MTF Measurements Per ISO 11979-2 Annex C Figure 5. Source: eyeonics

Most ophthalmologists refrain from performing YAG capsulotomies, fearing that patients will develop cystoid macular edema or that the capsulotomy will increase the risk of retinal detachment, but those ideas are based on out-of-date experience.

Prior to performing a YAG capsulotomy, however, surgeons should allow the IOL to seal into place, which occurs at about 3 months’ postoperatively.

Doane: With the crystalens IOL, I do not perform YAG capsulotomies because of decreased distance vision. If a patient with excellent distance vision and improved near vision after crystalens IOL implantation retains distance vision over time but stalls or reverses field with near vision, then I will consider a YAG capsulotomy. With the crystalens IOL, and likely with all presbyopia-correcting IOLs, ophthalmologists will not perform a YAG capsulectomy due to decreased distance visual function but because of decreased near visual function.

Carter: Early in my experience, I noted that some patients implanted with a crystalens IOL had excellent 20/20 distance vision and also had J1 or J2 vision but had complaints. A patient’s capsule may have had a small amount of fibrosis, slightly increased reflex, or a wrinkle. After performing a YAG capsulotomy, patients would return satisfied with their unchanged 20/20 and J1 or J2 vision. The crystalens IOL demonstrates that a small amount of capsular opacity or fibrosis changes the quality of a patient’s vision significantly because the IOL sits close to the nodal point.

Enhancement rate, predictability

Slade: Discuss enhancement rates and predictability in presbyopic IOL channel.

Doane: The enhancement rates with the presbyopic IOLs are significant and likely close to the percentage of patients who a practitioner refers to an optician for distance correction after bilateral distance monofocal IOL implantation. The optical shop does not guarantee satisfaction with presbyopic IOLs. The surgeon, therefore, must be prepared to either perform correction of the low refractive error by corneal surgery or sulcus piggyback lenses or refer the patient to a corneal refractive surgeon for final correction.

Waltz: Cataract surgeons who want to become refractive lens surgeons should review their last 100 cases of cataract surgery. It is unlikely that they performed a refractive enhancement.

New refractive lens surgeons are unhappy if they miss a target refraction. The first 100 cases a new refractive lens surgeon performs will have a 20% or better refractive enhancement rate. The ophthalmic community should redefine what is acceptable and normal for new surgeons so that they feel good moving forward when they have a 20% refractive enhancement rate.

Doane: New refractive lens surgeons who are unhappy with their refractive enhancement rate can also review their last 100 monofocal IOL cases to find the percentage of patients who must use glasses to improve night vision. Perhaps 30% of monofocal IOL patients must wear glasses. Initially, The enhancement rates for presbyopic IOLs are probably identical to the percentage of patients with monofocal IOLs who need glasses.

Colvard: I agree. I find myself performing enhancement on 10% to 20% of crystalens patients, and yet, I almost never perform enhancements on standard monofocal patients. My colleagues and I wanted to know if the crystalens was less predictable than the standard monofocal or if our desire to achieve emmetropia in crystalens patients had simply raised the bar of what we felt was an acceptable refractive outcome. We looked carefully at a series of 60 consecutive monofocal eyes and 60 consecutive crystalens eyes to determine whether the crystalens IOL is inherently less predictable than standard monofocal IOLs. We found no difference between monofocal results and the crystalens IOL results in terms of refractive outcome vs. preoperative targets (Figure 6).

Prediction Error (SE from Target) Figure 6. Prediction error of the crystalens IOL Source: Colvard M

Postoperative follow-up

Slade: What anti-inflammatory treatment regimen do you use when implanting the crystalens IOL?

Doane: I use prednisolone acetate four times a day for 2 days preoperatively along with a nonsteroidal anti-inflammatory drug (NSAID), typically Acular (keterolac tromethamine ophthalmic solution 0.5%, Allergan) qid. Postoperatively, I use higher cortical steroids than when implanting other IOLs. Prednisolone acetate 1% along with a nonsteroidal will be tapered over a month, and an NSAID will be used 1 to 2 weeks postoperatively. Some effort is necessary to minimize capsular fibrosis and contraction in the early postoperative period to stabilize the plates and the IOL in the desired position.

Carter: I use prednisolone acetate and an NSAID, usually Voltaren (diclofenac, Novartis), for 2 days prior to surgery, and then I use the same agents four times a day for 2 weeks after surgery and then two times a day for 2 more months after that, for a total of 10 weeks.

Practice management

Slade: How can ophthalmologists prepare their staff for incorporating the crystalens IOL into clinical practice?

Carter: The chair time with the crystalens IOL and multifocal IOLs is similar. The most important point is to spend a large amount of time preoperatively with patients discussing expectations and the pros and cons of the IOL implant they are receiving. As a result, chair time afterward is significantly reduced.

Doane: Ophthalmologists cannot underestimate the amount of work required to prepare staff for adding the crystalens IOL or any presbyopic IOL into practice. My practice began 10 years ago as an exclusive laser vision correction practice. Prior to the commercial availability of presbyopic IOLs, I performed refractive lens replacement procedures with planned monovision to facilitate near and intermediate function. With the crystalens IOL, the staff needed to be trained on how to check near vision consistently, which was something they never did before.

Staff should be educated on why presbyopic IOL procedures may be more expensive than LASIK. A line item of procedures will best show the value of presbyopia-correcting IOLs. The whole team will then understand a presbyopic IOL provides benefits that LASIK cannot. LASIK cannot correct presbyopia to the same degree as a presbyopic IOL. The process is different, and ophthalmologists must ensure that the team understands the value of giving a patient distance, intermediate and near vision, which is almost priceless.

Waltz: Ophthalmologists should spend time with staff to ensure that they are comfortable with presbyopic IOL decisions.

The staff, especially at a traditional cataract practice that has not been involved with refractive surgery, may adopt the perspective that an ophthalmologist is operating on normal eyes. The staff may question implanting a presbyopia-correcting IOL when glasses can correct a patient’s vision after basic cataract surgery. Therefore, helping staff understand the value of presbyopic IOLs is important.

Slade: Do you recommend that surgeons conduct a staff education seminar to inform staff of the administrative changes with presbyopic IOLs?

Doane: All staff members, including operating room nurses and managers, administrative workers, the billing department, technicians, doctors and refractive educators, must understand the direction in which the practice is moving.

Waltz: I conducted a series of discussions with staff prior to introducing presbyopic IOLs, and every 4 to 6 months after, we have additional discussions. It is a challenge for the staff to accept new procedures, and a 2- or 3-hour meeting is difficult to conduct. In my experience, a 1-hour meeting a couple times a month effectively communicates information.

"I believe a patient implanted with a crystalens IOL is easier to comanage with an optometrist than a patient implanted with a multifocal IOL." — Kevin L. Waltz, OD, MD

I also put incentives in place for my staff. My staff was reluctant to discuss corneal relaxing incisions (CRI) with patients. As an incentive for talking with patients about CRI, 20% of the cost for each CRI is placed into a pool that is awarded to the staff every 6 months. The incentive helped our CRI utilization rate, because the staff is not as resistant to having the discussion and spending extra time with patients. My practice will incorporate the same incentive program with presbyopic IOL procedures.

Slade: Discuss comanaging presbyopic IOL patients with optometrists.

Waltz: I believe a patient implanted with a crystalens IOL is easier to comanage with an optometrist than a patient implanted with a multifocal IOL. Optometrists understand the potential limitations of a crystalens IOL. If a surgeon has a significant comanagement practice, the postoperative algorithm for comanagement with a crystalens IOL is beneficial for optometrists.

Slade: How should ophthalmologists approach billing for presbyopic IOL procedures?

Doane: With all presbyopic IOLs, ophthalmologists must separate the cataract component from the upgraded presbyopic component. In my practice, I clearly state to a patient that his or her insurance will pay for cataract extraction but will not pay for any of the presbyopic component. My best advice to surgeons is to not get insurance companies or Medicare involved. Surgeons should not send a bill to third-party payers for the extra services.

Slade: When should surgeons notify patients about additional charges in implanting a presbyopia-correcting IOL?

Doane: Notifying the patient of additional charges should occur at the patient-education level. Surgeons must inform patients that, with the upgrade, patients will have to pay a certain amount out-of-pocket.

Additionally, ophthalmologists should have financing options available, similar to those in standard laser vision-correction practice.

Slade: Many surgeons attending presbyopic IOL courses are cataract surgeons who do not perform refractive surgery. What internal and external marketing practices can a cataract surgeon use to shift from a cataract-only practice to one offering refractive surgery?

Colvard: Internal marketing is important for cataract surgeons, because it informs patients who are already in the practice of the many options available with presbyopic IOLs. The most effective way to educate patients on different treatment options is to send them a newsletter describing the technology. Ideally, surgeons should provide new patients with information about the technology before patients arrive at the office. This gives basic information before their visit and allows them to ask more informed questions.

Doane: Two years ago, any ophthalmologist involved with cataracts in the United States knew the presbyopic solution was coming. Now, all ophthalmologists are discussing presbyopic IOLs, and a large number of surgeons are getting involved with implants. At this point, in the patient counseling process, ophthalmologists should discuss alternative treatments. The alternatives are beyond a monofocal IOL. Ophthalmologists should inform patients of the alternative with presbyopic IOLs that will minimize the need for glasses. Ophthalmologist who are not presenting the information are not informing patients of all reasonable alternatives and may upset some patients who may feel they have been ill-informed. It is analogous to a practitioner in 1996 who spoke to a patient about radial keratotomy and not about laser vision correction because the practitioner did not offer laser vision correction. The patient needs to be fully informed of surgical options if the patient is a candidate.

Future considerations

Slade: What is the future for presbyopic IOLs?

Carter: I believe that within 5 years, the surviving IOL platform will be an accommodative-type platform, such as the crystalens IOL or its successor. The multifocal or bifocal platforms will have become extinct.

Waltz: Presbyopic IOLs will lead to more positive interactions with colleagues and competitors. Many surgeons will find it difficult to provide these IOLs and will seek their colleagues with whom they will comanage these patients. I anticipate that comanagement will lead to improved interactions among local surgeons.

Woodhams: In the coming years, a significant amount of refractive surgery will become intraocular surgery, not just corneal surgery. I believe the group undergoing surgery will be young, with the primary lensectomy surgery group between 40 to 65 years old. I think many patients, by the time they are eligible for Medicare, will already have had their lenses removed and replaced with increasingly more sophisticated presbyopic accommodative IOLs.

Slade: Patients will undoubtedly benefit from the evolving presbyopic IOL technology and sophisticated designs. Current advances in accommodative IOL technology can improve all ranges of vision and reduce the risk of glare and halos.

I would like to thank the panel for their comments, Ocular Surgery News for organizing this symposium and eyeonics for providing its support.

References

1. Masket S. New accommodating IOL designs. Paper presented at: American Academy of Ophthalmology Annual Meeting; November 2003; Anaheim, Calif.
2. Holladay JT. Panel presentation at: Future trends in ophthalmology; October 1, 2005; Miami, Fla.
3. Guttman C. Multimodal mechanisms of lens may account for near vision performance. Ophthalmology Times. June 15, 2005.
4. United States Food and Drug Administration Web site. Available at: http://www.fda.gov/cdrh/pdf3/p030002.html.
5. Waltz KL. Accommodative arching of the natural lens and the crystalens IOL. Paper presented at: Annual Symposium of the American Society of Cataract and Refractive Surgery; March 19, 2006; San Francisco, Calif.