Symposium: Milestones in Medicine: Adding Accommodative IOLs to Your Practice

R. Bruce Wallace III, MD: In November 2003, the first accommodative IOL, Crystalens (eyeonics, inc., Aliso Viejo, Calif.), was approved for implantation in the capsular bag to correct aphakia and presbyopia in adults who have undergone cataract extraction. I would like to hear about the practical function of the Crystalens. How do you explain to your patients how the Crystalens works?

Stephen G. Slade, MD: The majority of my patients who receive the Crystalens are in their mid 50s and early 60s and are presbyopic with cataracts or large refractive errors. They are well aware of the vision loss that they have experienced, and they remember their near vision ability. When counseling patients, I explain that implantation with the Crystalens will rejuvenate a large portion of the near vision, and patients will have less dependence on reading glasses. Another advantage is the actual repair of the cataract, which is indicated on the labeling. Implantation with the Crystalens will also fix any significant amount of myopia or hyperopia that a patient has.

I have found that my patients understand the risks and benefits of the surgery and are anxious to be rid of their dependence on reading glasses and to simply see better.

Wallace: Do you find that patients in this specific age group are interested in receiving LASIK, but are not aware that an alternative option such as the Crystalens exists (Figure 1)?

Slade: In my experience, patient populations overlap. Patients in their mid 50s are often good candidates for the Crystalens. Eligibility depends on any lens changes that they have, the degree of myopia or hyperopia and the level of compromise with accommodation. When LASIK is performed on a patient with early-stage cataracts, a physician may actually make vision functionally worse because he or she has disjoined the aberrations on the cornea that once meshed with the aberrations on the lens. As the spherical aberration of the lens changes, the cornea no longer compensates for the patient’s natural lens because the cornea has been altered by LASIK.

Jeffrey Whitman, MD: I prefer to show patients slides or a video of the posterior, intermediate and anterior lens movement for their close up vision so they are able to see what the Crystalens will do for them. I explain to them how the Crystalens will provide a natural quality to their vision without the use of glasses or contact lenses. I also explain that, with the natural movement of the eye and the Crystalens, their postoperative vision will be similar to their pre-presbyopic vision.

In my practice, the Crystalens has heralded in the new era of refractive cataract surgery. Many patients who come in for LASIK have early cataracts. If patients are at least 55 years old, physicians are more compelled to perform refractive cataract surgery than to proceed with LASIK and induce more aberrations in the cornea.

Figure 1 Figure 1: Highest interest shown in Accommodating IOLS; lowest interest shown in Multifocal IOLs. This information is included in the 2004 Survey of US ASCRS members, presented by David V. Leaming, MD, at ASCRS 2005. (Figure 1 Courtesy of David V. Leaming, MD)

Harvey L. Carter, MD: My threshold for LASIK surgery has changed in recent years. For example, I would previously perform LASIK on patients older than 40 years of age with impunity and/or refractive errors up to -12 D. Surgeons have commonly excised more than 100 µm of corneal thickness during these procedures, but since patients are living longer, they may need that corneal tissue later in life. Therefore, as the life span continues to increase, surgeons may need to alter their surgical procedure of choice.

Preoperative counseling

Wallace: What do you discuss with patients in terms of the risks that are associated with this procedure compared to other procedures such as LASIK?

Whitman: I explain to patients that I strive for perfection. Patients must understand that surgeons are not just trying to get close with this lens; they are trying to give the best vision possible. It is possible that the lens will need to be removed and replaced within the first weeks or that LASIK may be needed. If conditions warrant, patients must understand that their surgeon will do what is necessary to remedy the situation. Patients must be made aware that implantation of an alternative lens is a possibility.

I also inform patients that the major part of this surgery is the removal of the natural lens or cataract and the minor part is implanting the lens. This surgery is more of a lens removal surgery than it is a lens implant surgery. Jeffrey Whitman, MD

I also inform patients that the major part of this surgery is the removal of the natural lens or cataract and the minor part is implanting the lens. This surgery is more of a lens removal surgery than it is a lens implant surgery.

John F. Doane, MD: By nature, when a surgeon introduces a “presbyopic solution,” patients interpret this as “no more glasses and perfect vision at all focal points forever.” However, as with LASIK, surgeons must clearly and repeatedly provide realistic expectations. Crystalens patients may initially need assistance with near vision, but this need diminishes with time. Although the majority of patients remain spectacle-free in the long-term, not all patients will experience this result. Expectations must be understood by the surgeon, the staff and, most importantly, the patient.

Slade: In my experience, patients being implanted with the Crystalens are focused on the lens itself. This type of patient is different from one undergoing cataract surgery, where the focus is on removing the cataract. Crystalens patients are often under the impression that cataract removal is something that must be done just so they can receive the lens.

I do not tell all patients that the Crystalens will make them see perfectly up close and at distance. The majority of patients experience those results, but not all of them.

Steven J. Dell, MD: Many patients feel that implantation with the Crystalens will result in perfect vision at all distances. Therefore, it is necessary to manage patient expectations. If patients are not educated about likely outcomes, some will be disappointed. It is always better to under-promise and over-deliver.

Whitman: Unlike LASIK, which is a surface procedure, implantation with the Crystalens is an intraocular procedure. Patients must realize that Crystalens implantation is a surgical procedure and the risks found in cataract surgery exist in this procedure as well.

Stephen Updegraff, MD: I explain to patients that the plan is to implant a Crystalens. However, if the architecture of the eye is not perfect, I may not be able to use the Crystalens and may need to implant a multifocal IOL in the sulcus or use another IOL style.

Patient criteria and contraindications

Wallace: Besides refractive error and the characteristics listed in Figure 2, what would indicate that a patient is a good or bad candidate for implantation with the Crystalens?

Figure 2 Characteristics of an ideal Crystalens patient An ideal candidate for implantation with a Crystalens should have: cataracts previous hyperopia or myopia of 2 D or more good vision potential normal ocular health low corneal astigmatism realistic expectations and be 50 years of age or older Source: eyeonics, inc.

Doane: Patients who are eligible for this procedure fall into three categories. The first category consists of patients, regardless of age, with cataracts. The second group consists of patients with large spherical ametropias or astigmatism in whom LASIK or PRK in the form of bioptics will be performed. The third group consists of patients who have had prior corneal refractive surgery.

Updegraff: A pupil size of 4 mm or smaller is ideal.

Whitman: I have performed modified glare studies and looked at many pupil sizes. I have not found pupil size to be a problem with the Crystalens.

Updegraff: My emphasis is not so much on the glare, the starburst and halos because they are optical phenomena. I prefer to work with small pupils because I have found that they help with near vision.

Slade: My colleagues and I investigated the importance of small pupil size in regard to near vision and did not find a positive correlation in patients participating in the Food and Drug Administration clinical trial. We also investigated patient-reported side effects, such as glare and halos, compared to a control group of patients with monofocal IOLs, and did not see an increase with the Crystalens. I agree with Dr. Updegraff. A smaller pupil is going to help, but I do not believe that a larger pupil will be detrimental.

Dell: The extreme posterior positioning of the Crystalens and its excellent centration have protected against dysphotopsia.

Wallace: Please comment on relative and absolute contraindications for the use of the Crystalens.

Whitman: A patient desiring perfect vision immediately postoperatively should be avoided. Also, there is no point in attempting Crystalens implantation in a patient with phacodonesis or trauma that results in a less than perfect capsule. Relative contraindications include patients with perfect distance vision, those who are near plano or have excellent close-up vision, and those in their 50s with a refractive error of –2.25 D and excellent near vision.

Slade: Relative surgical contraindications include patients with a traumatic cataract, patients with pseudoexfoliation and patients on Flomax (tamulosin hydrochloride, Boehringer Ingelheim). It is not impossible to implant the Crystalens in these patients, but it is more difficult. It is imperative that patients understand that they may not be able to receive the Crystalens because of such contraindications.

Updegraff: Two more significant contraindications are patients with diabetes and patients who may need retinal surgery in the future. The retinal surgeon with whom I work has performed three vitrectomies on patients implanted with the Crystalens. The surgeries were challenging because of the movement of the IOL during surgery. Also, I do not recommend implantation with the Crystalens in a patient with age-related macular degeneration.

Wallace: What are your experiences implanting the Crystalens in patients who have had LASIK or PRK?

Whitman: I have performed nine Crystalens implants on patients who have had RK and have been even more satisfied with their results than those of post-LASIK patients.

Slade: Crystalens implantation is usually successful for the majority of our post-RK patients. An added significant advantage is that the lens has the potential to compensate for the fluctuation in vision that RK patients may have.

Updegraff: I have found that post-RK patients are some of the most challenging patients to work with. They have very high expectations. Many of them had excellent vision for years and only recently have experienced progressive or latent hyperopia.

I have only had to explant one Crystalens for severe consecutive hyperopia on a post-RK patient approximately 10 days postoperatively. In that patient, I was amazed at how quickly the haptics fibrosed into the bag. I was able to explant the IOL without a problem, but it made me aware that at approximately 2 weeks, there is a window where the IOL is easy to exchange. However, after 2 weeks, the window begins to close. Surgeons must know that in post-RK patients in which a refractive surprise may occur, a decision to perform an explantation may need to be made sooner with a Crystalens than with a standard three-piece IOL.

With a three-piece IOL, surgeons normally wait 2 months for the cornea to stabilize prior to making any surgical decisions. With the Crystalens, at some point, surgeons will need to make a decision to either stay with the lens or do an exchange. With a regular, monofocal lens, surgeons have more of a luxury to wait and see.

Whitman: I agree. In RK patients, 6 weeks is often not enough time for the lens to truly settle down. The STAAR AQ-5010V (STAAR Surgical, Monrovia, Calif.) low-power lens implant works well in the sulcus on these patients if small corrections are needed after the Crystalens has fibrosed in the bag.

Doane: I have had an excellent experience in post-RK, post-LASIK and post-PRK patients. However, additional work may be required to correct for residual astigmatism or spherical refractive error. If a patient has had a prior RK procedure, I recommend that PRK is performed. Also, if a patient has had a prior LASIK procedure, I recommend lifting the flap to correct the necessary ablation.

Procedure techniques and characteristics

Wallace: How does cataract surgery involving the Crystalens differ from other cataract surgeries?

Whitman: Cataract surgery demands good hands and a strong heart, but when we, as surgeons, perform this type of surgery, we demand perfection of ourselves. The main differences among procedures are that we proceed slower, are more aware of all aspects, observe every movement of the capsule and are more meticulous. Implanting the Crystalens has made me a better cataract surgeon.

I am careful with each step, down to the last bit of irrigation and aspiration (I&A). I want to get the IOL in a good position and have a perfect capsulotomy to give patients the best chance of having a functioning lens. Once a surgeon masters a capsulotomy, he or she can perform Crystalens implantation.

Every technique refinement that is performed during the Crystalens implantation leads to better cataract surgery. These refinements include the watertight stab wound, a more centered, controlled capsulorrhexis and better cortical clean-up. Stephen G. Slade, MD

Slade: Every technique refinement that is performed during the Crystalens implantation leads to better cataract surgery. These refinements include the watertight stab wound, a more centered, controlled capsulorrhexis and better cortical clean-up. They are all advantageous to the patient.

I find myself using many of the techniques for Crystalens implantation in my regular cataract surgeries as well.

Updegraff: Even though the majority of the nuclei are soft, a surgeon must modify his or her technique for this. I recommend cortical cleaning hydrodissection and hydrodelineation of the nucleus, as made popular by I. Howard Fine, MD. I use a 0.5-mm I&A tip so that I minimize the use of the phaco tip. Meticulous attention to detail will pay off.

Wallace: In terms of correcting astigmatism at the time of surgery, have you been successful, or do you try to avoid patients with astigmatism?

Doane: Patients with astigmatism are excellent candidates for implantation with the Crystalens. If patients have an astigmatism of less than 2.5 D, I treat them with limbal relaxing incisions (LRIs). If patients have an astigmatism greater than 3 D, I recommend a planned bioptics treatment, which has worked well for up to 6 D of corneal astigmatism.

Updegraff: When surgeons implant refractive IOLs, it is imperative that they have access to a laser. Prior to surgery, patients must be educated on the refractive enhancement procedures and what they can expect. At 12 weeks postoperatively, a surgeon may have to perform a LASIK or PRK touch-up, depending on the situation. Therefore, surgeons must have those techniques in their armamentarium. I move the incision depending on the location of the astigmatism. I then operate on the steep axis and perform arcuate keratotomy during surgery. Any residual astigmatism is fixed with the laser.

Dell: I perform LRIs in the majority of my Crystalens patients. If surgeons neglect this component of patient ametropia, even the best biometry will be worthless. Surgeons spend a significant amount of time trying to improve the accuracy of their biometric measurements, and the same emphasis must be placed on astigmatism management.

Whitman: I feel that the Crystalens surgery lends itself to bioptics treatment nicely, particularly for patients with high amounts of astigmatism where a laser would not be ideal as sole treatment.

Postoperative experiences

Wallace: Please describe some of your postoperative experiences with the Crystalens.

Updegraff: I have noticed an interesting phenomenon in my practice and in general. Patients do not feel it is negative when they need to have an enhancement with LASIK.

In my practice, approximately 95% of the patients who eventually receive the Crystalens initially desire LASIK. After patients are educated about the Crystalens and how it can improve their vision, they desire to receive the Crystalens procedure.

Whitman: In my office, my colleagues and I have had to perform LASIK on only approximately 7% of our Crystalens patients.

Carter: I have found that approximately 4% of my patients receive a LASIK enhancement. Also, at the time of surgery, I perform LRIs for as little as 0.5 D of astigmatism. I do this because I want patients to be content immediately instead of telling them that their vision will be blurry and astigmatic for 3 months and they will need to return for more enhancements.

Updegraff: I provide my patients with any needed enhancements as a package deal. Do you charge the patient for enhancements?

Whitman: I include all needed enhancements in a package deal.

Dell: In my practice, enhancements for routine Crystalens cases are part of a package price as well. However, if patients come in with a history of previous refractive surgery, we advise them that the chances of needing a touch-up are high. Under this scenario, refractive enhancements are not included, but are performed at a reduced fee.

Wallace: How quickly are patients who have received the Crystalens able to function normally after surgery? What expectations do you give patients about what their vision will be like postoperatively?

Doane: I expect distance vision to be excellent. If this is the case, the intermediate vision should be excellent as well. Patients must understand that near vision will improve throughout the first 24 months after surgery. I have found that approximately 30% of individual eyes see J1 at 1 month postoperative, 60% of individual eyes can see J1 at 12 months postoperative and 80% of patients can see J1 at 24 months postoperative.

Updegraff: Patients who had high hyperopia are thrilled to be able to see closely again. It is important to remember, though, that patients are dilated for 2 to 3 weeks, which can be a trying experience. I make a point to warn patients that it will be 3 months before they actually start experiencing an improved range of vision and that their vision will continue to improve for at least a year. Patients must understand that this is a continuum and must not have abnormally high expectations for immediate near vision.

Whitman: It is imperative to spend time with patients on accommodative exercises, such as having them change their focus between a distant and near target as fast as they can for 5 to 10 minutes. This will increase their eye’s focus flexibility. Patients must understand from the beginning that there is a plan: distance vision is first, followed by intermediate vision. Also, I find that the majority of my patients experience intermediate vision within 2 or 3 weeks. I leave their nondominant eye slightly minus, which helps ensure that vision improvements will occur more quickly than expected.

It is wise for new surgeons to aim for myopia at first. If a patient ends up too minus, the surgeon can always go back and perform LASIK later. However, a surgeon does not want a patient to end up 0.5 D or 1 D because the patient would face lens removal and replacement.

Wallace: What type of distance, intermediate and near vision can patients expect immediately after implantation with the Crystalens?

Slade: Immediately postoperatively, the standard regimen calls for dilating the patient. Therefore, patients are typically not able to see well at near but they have adequate distance and intermediate vision.

Whitman: Assuming that there is little inflammation immediately postoperative, the majority of patients notice an immediate improvement in distance acuity. Intermediate vision, such as using the computer, should improve within 2 to 3 weeks in the majority of patients. The best functional near vision occurs at different time periods, from weeks to months, depending on patients’ individual accommodative abilities.

Wallace: What other comments do you have about the surgical experience?

James Denning Our internal outcomes data show that the A-scan measurements and the outcomes on RK patients are closer to target than that of patients who have had LASIK.

James Denning: From a statistical standpoint, surgeons are beginning to see many patients who have received RK or LASIK come in for Crystalens implants. Our internal outcomes data show that the A-scan measurements and the outcomes on RK patients are closer to target than that of patients who have had LASIK.

Wallace: What do eyes that are healing well look like? What do eyes that a surgeon should be concerned about look like?

Updegraff: Evidence of posterior IOL vaulting is the most critical. If there is evidence that patients are mid-vaulted, then they must be atropinized and cyclopleged.

Whitman: I agree. However, evaluating patients who have received Crystalens implants is no different than evaluating typical cataract patients. Patients should look how you would want patients to look after cataract surgery.

Wallace: When treating a patient who has received a Crystalens implant vs. a typical cataract patient, do you alter your postoperative regimen in terms of medications?

Whitman: I administer a cycloplegic drop to patients who have received a Crystalens implant.

Carter: When I evaluate patients 1 day postoperatively, I look at the anterior capsulotomy size to see if it changed after surgery. I also look at whether the posterior surface of the optic is in contact with the posterior capsule, and I make a note if that is not the case. I then begin grading how far back the anterior surface of the optic is from the anterior capsule, and I keep track of that over time.

Wallace: Please comment about evaluation in the immediate postoperative period, checking the posterior placement of the lens and the incidence of cycloplegia.

Whitman: I check the position of the Crystalens at 1 day and 10 days postoperatively. If I notice an unusual amount of postoperative myopia, I would suspect anterior displacement of the Crystalens. Confirming or restarting cycloplegia will most often resolve the matter as long as no wound leak is present. It is rarely necessary to surgically reposition the Crystalens.

Slade: It is imperative to ensure that the IOL is in the proper position postoperatively. It should be centered and noticeably vaulted posteriorly. The iris should be dilated as well with the current recommendations.

Wallace: Would you consider a patient who has received a Crystalens implant stable beyond 1 month postoperatively?

Whitman: It is atypical to observe a significant amount of change beyond 1 month postoperatively, unless there is the beginning of fibrosis in the capsule. Fibrosis in the capsule can occur during the first year after surgery and requires vigilance. I perform a YAG laser capsulotomy on the majority of my patients early in their postoperative care, because it helps prevent capsular contraction syndrome (CCS). Since I initiated that postoperative care, I have not seen any cases of CCS and my patients experience better reading vision than before the YAG procedure.

Updegraff: Out of a retrospective series of 168 eyes, with a 6-month follow-up, I witnessed a 2.8% rate, or five cases, of CCS, which is optic tilt and induced cylinder secondary to capsular fibrosis. Consequently, I perform a YAG procedure on all patients at 2 to 2.5 months and have not had problems with capsular fibrosis or CCS.

The cases of CCS were corrected with YAG capsulotomy. All of the IOLs vaulted posterior and maintained their range of accommodation. However, two IOLs experienced vitreous prolapse into the anterior chamber around the optic. Once a patient develops an asymmetrical vault, tension occurs on the capsular bag. Therefore, even though a surgeon attempts to perform a controlled capsulotomy, extension of the capsulotomy can occur out to the edge of the 4.5-mm optic. If a surgeon initially performs a capsulotomy at 2 months, while there is no tension on the capsular bag, he or she can then perform a controlled capsulotomy without risk of extension and vitreous prolapse.

Carter: Have you seen any cases of cystoid macular edema (CME) or adverse effects as a result of performing 100% YAG laser capsulotomy at 10 to 12 weeks?

The theory of accommodative arching

Kevin Waltz, OD, MD The natural crystalline lens found in the human eye changes its radius of curvature with accommodative effort. The accommodative ability of the natural lens changes over time. For example, the lens in a young adult’s eye dramatically changes its radius of curvature over the majority of its surface, whereas the lens in a 35 year old changes its radius of curvature only over a smaller portion of its entire surface. This decreasing response to accommodation continues for decades until eventually there is no response. The goal of treating patients with presbyopia with IOL implantation is to reverse this decreased response as much as possible. The Crystalens (eyeonics, inc., Aliso Viejo, Calif.) has been proven to reverse the decreased response of the natural lens to accommodation. Its Food and Drug Administration labeling allows Crystalens to claim a treatment of approximately 1 D of accommodation at the time of cataract surgery. There is evidence that the majority of patients who have been implanted with the Crystalens see well at near vision. Basic geometric optics suggest that it is unlikely that the Crystalens can move forward enough to provide the measured level of near vision. There are several theories as to how the Crystalens actually works. One possible explanation is that a patient with a smaller pupil has more accommodating ability. Another theory is a phenomenon that I have measured that I call accommodative arching. Figure Figure: A series of images of the right eye of a 72-year-old man who was implanted with a Crystalens 3 months prior were taken over a few minutes with a Tracey Wavefront Aberrometer (Tracey Technologies, Inc., Houston, Texas). The red is increased minus power and the blue is increased plus power. The image on the left is with maximum accommodative effort and shows a peak power change of 10 D in the red and an associated area of decreased power. The middle image is the eye relaxing its accommodation. The image on the right is fully relaxed accommodation. These changes in wavefront are most likely caused by changes in the radius of curvature of the IOL with accommodation. (Figure courtesy of Kevin Waltz, OD, MD) Accommodative arching is a localized change in the radius of curvature with accommodative effort that is present in all normal adult crystalline lenses and in some patients who have been implanted with a Crystalens. Accommodative arching is an area of dramatic change in the power of an IOL over small time intervals that can be explained only by a change in the radius of curvature of the Crystalens. When accommodative arching is combined with a decrease in pupil size, it accounts for a significant change in the focusing power of the eye. This is true for the natural crystalline lens, as well as for the Crystalens. Therefore, it appears that the Crystalens, when implanted during cataract surgery, is a significant step in reversing the effects of aging in the eye.

Updegraff: I have not witnessed any cases of CME or adverse effects.

Whitman: I have not witnessed any incidences of CME or adverse effects. However, one patient developed an extensive amount of glare. Prior to the YAG laser capsulotomy, the patient experienced no daytime or nighttime glare.

Updegraff: Pupil size can play a role in the development of glare following a capsulotomy. If a patient has anterior capsular fibrosis or capsular phimosis, he or she may develop glare from the edge of a fibrotic anterior or posterior capsule.

Doane: In the FDA studies, we did not see a significant incidence of CME or adverse effects. After we began teaching the courses, we decided to make smaller capsulorrhexes (approximately 4 mm to 4.5 mm) to minimize early anterior vaults that were thought to be due to wound leakage. Although I had not previously come across anterior vaults due to CCS, I suddenly began to see them.

Currently, I perform all my capsulorrhexes at 5.5 mm to 6 mm with a continuous curvilinear capsulorrhexis (CCC) and, in the last 3 months, I have not seen a single case of CCS.

Dell: I agree with Dr. Doane. The smaller capsulorrhexis is the culprit in the majority of CCS cases. However, I do not agree with the idea of a routine posterior capsulotomy. I have not found that to be necessary. I feel that it is better to evaluate the patients individually and perform YAGs on an as needed basis.

Slade: In the FDA trial, surgeons made 5.5-mm or 6-mm capsulorrhexes and did not see any cases of CCS. Due to these findings and our experiences with CCS, surgeons have reverted to a larger capsulorrhexis. As long as the polyamide loops at each end are covered, the IOL is initially implanted so that it is vaulted. The IOL is kept cyclopleged and remains vaulted, which leads to better overall performance.

Carter: My colleagues and I reviewed the first 500 eyes on which the Crystalens was implanted and investigated the rates of CCS and fibrosis. We found that the rate of each was 1% to 2%. We then investigated the average capsulotomy size, and found it to be approximately 4.3 mm, which is smaller than that which the FDA study used. When the capsulotomy size was made smaller, the incidences of CCS and fibrosis markedly increased.

Since my colleagues and I began performing YAG laser capsulotomies on patients with IOL implants, we have not had to explant a lens because of CCS.

Wallace: The majority of patients who have undergone an IOL surgery that involved removal of the crystalline lens and the implantation of an IOL experience some CCS. How can the incidence of CCS be reduced?

Doane: As Figure 3 mentions, I have found the size of the capsulorrhexis to be a component in the prevention of CCS. Another significant component is any residual lens epithelial cells or cortex. It is only a matter of time before the lens epithelial cells that remain become metaplastic and a fibrous metaplasia results. The patient will also experience contractile forces from the actin filamentous change, which causes the IOL to move in a certain direction.

Creating a 5.5-mm CCC incision and removing the cortex that may be caught up on the polyamide loops are necessary to alleviate CCS.

Figure 3 Recommendations to prevent CCS 5.5-mm to 6-mm capsulorrhexis meticulous cortical clean up minimum of 4 weeks of anti-inflammatory agents Source: eyeonics, inc.

Wallace: Please explain what you do when striae are present in the posterior capsule. Where should YAG be done and why?

Whitman: I am not concerned with striae in the posterior capsule. I perform a YAG procedure in the majority of my patients centrally 3 months postoperatively.

Carter: When dealing with posterior capsular striae, I make a kite-shaped capsulotomy with the tail of the “kite” at the area of the striae and the top of the “kite” approximately 1 mm inside the opposite hinge or at the edge of the optic.

Wallace: Please discuss your most recent explantation rates.

Doane: I have implanted 450 Crystalenses and have explanted only one due to dysphotopsia. This case was unique, as the patient had small pupils. In that specific case, miotics were used but the patient still experienced nighttime symptoms that did not disappear. To date, in the 18,000 lenses implanted, only three have been explanted as a result of dysphotopsia.

Wallace: Please comment on any other postoperative complications you have experienced.

Whitman: The distance vision experienced with the Crystalens is equal to that which is experienced with any IOL implant. With the Crystalens, distance vision has never been a topic of concern at any time of day. I have experienced a zero explantation rate for dysphotopsia. One lens was removed and replaced with another Crystalens due to an initial malposition.

Updegraff: Cortical cleanup is imperative. However, surgeons will never be able to remove all of the lens epithelial cells and there will always be some form of capsular contraction.

Carter: There is an extremely low incidence of CCS, regardless of the size of capsulotomy. Meticulous cortical cleanup, along with prolonged use of anti-inflammatories, decreases the rate of CCS.

With proper YAG laser capsulotomy techniques, the IOLs will return to their appropriate posterior vaulted position and will continue the range of accommodation. Even though CCS can be a nuisance, it is easily treated. It does not require explantation of the IOL and the patients are satisfied.

Wallace: Does keeping patients on steroids longer postoperatively help avoid other complications?

Doane: Extending the corticosteroid regimen up to 8 weeks and including a nonsteroidal for at least 4 weeks is essential to guard against CCS.

Slade: It is important to state that Crystalens is not the only IOL that experiences complications. This is the first time that a dynamic lens that moves has existed. It is the good fortune of other accommodative and dual-optic IOLs that are being developed that Crystalens is dealing with adverse outcomes now because they will all eventually have to face them.

Wallace: How should the Crystalens be positioned in the eye after implantation?

Whitman: If I am making an ovoid capsulotomy, I prefer to leave the long axis toward me because it is easier for me to perform cataract removal and I&A. I then rotate the lens into a 12 o’clock and 6 o’clock position.

Wallace: What are some advantages of the Crystalens compared to other IOLs?

Updegraff: One advantage of the Crystalens is the quality of vision that it provides. Its ability to move forward and backward gives patients an advantage. Also, patients do not experience glare and halos with the Crystalens, which may occur with other IOLs.

Whitman: FDA studies proved that 3.3% of patients reported severe night vision problems and 11.6% of patients reported moderate ones.²

Slade: The Crystalens is not a bifocal or trifocal IOL. Patients will have the ability to see the area between the near and far points of focus. They typically experience intermediate vision of J1 and have excellent far vision like they experienced in their youth.

Internal marketing

Wallace: Are there any new techniques in the area of internal marketing? What works well in your respective practices?

Daniel Chambers: My colleagues and I have used the brochures and information that have been provided by eyeonics, inc. and they have been useful in creating an interest in the procedure. We have also had success with the Patient Education DVD.

Our staff has become efficient at choosing patients who would benefit from the Crystalens, particularly those who are hyperopic and those with early or incipient cataracts who note glare complaints. Extensive staff education has been most effective.

Whitman: The conversion from LASIK, particularly for patients 50 years of age and older, to Crystalens is the most important step that is being taken in terms of internal marketing changes. It is important for the staff not to confuse patients and leave them feeling conflicted. Therefore, it is necessary for the staff to provide patients specific examples, such as, “Here are the advantages and disadvantages to this procedure. Let us see what we can find that will be appropriate for you.”

Patients can undergo LASIK now and undergo implantation with the Crystalens later. This gives surgeons the chance to bond with their patients. Even if a patient decides not to have a procedure done immediately, he or she understands the available options.

Updegraff: A challenge is educating the staff and developing a system that is right for a surgeon’s practice. Introducing a 50 year old, who initially contemplated LASIK, to a refractive lens implant takes skill by the physicians and counselors. It is important to be decisive and ensure that patients feel decisions have been made by the physician and options are concrete and clear.

For the majority of patients, even if they choose not to have the Crystalens procedure at the time, they leave thinking, “Wow. No one told me that before. You gave me that option.” A surgeon’s credibility increases when he or she can offer different procedures. Invariably, patients will return and have the Crystalens implanted.

Doane: I always ask patients what they want. If they say, “I never want to wear glasses again,” they are not a LASIK candidate. A surgeon will need to offer another option, such as a refractive IOL.

Slade: Another one of the advantages of the Crystalens is that this lens self-refers. Much like LASIK, Crystalens patients refer other patients. I do not know of another IOL that people ask for by name.

Denning: This technology is a marriage between LASIK and cataract surgery.

Chambers: In my practice, I have seen a 20% reduction in the percentage of LASIK procedures in patients older than the age of 45. This means that surgeons are more comfortable in providing an alternative to our patients. For patients who have been diagnosed with a cataract, at least 50% of the non-Medicare patients opt for the Crystalens procedure.

Wallace: How do you provide incentive and encourage your staff?

Chambers: In our office, we have had a generalized bonus system for years. With the introduction of Crystalens, we have been able to become more financially successful in achieving our profit goals. As such, we have shared our financial success with our staff. There is a general feeling in our practice that if we are successful financially, we all benefit.

External marketing

Wallace: Are any particular external marketing methods better than others?

Whitman: Techniques that are useful for marketing LASIK are also useful for marketing the Crystalens. Educating the market that another option is available is imperative because until now people did not know that the Crystalens existed.

Chambers: The three traditional methods for LASIK marketing have been print, radio and television. They still remain strong marketing vehicles. Marketing on television in the early morning hours has been effective with attracting Crystalens patients. My opinion rests with the needed frequency of ads at affordable rates during this time of day. Print advertisement is also a strong marketing technique, mainly because older presbyopic patients tend to be more mature and read the newspaper regularly.

Of the three major marketing techniques, unlike LASIK, radio seems to be less effective for the Crystalens in our practice. While our practice targets patients between 50 and 65 years of age, we may not be selecting the “appropriate” population segment that can afford the upgraded Crystalens services. Or, we may need to direct our efforts and focus more on talk radio shows. Our radio advertisements are commonly aired during commuting time because the target audience is not in the traditional stay-at-home Medicare market, but rather the productive, independent and active population who are still employed.

Wallace: How do you get your target audience to respond? Do you offer free seminars and screenings?

Whitman: In our practice, we offer seminars and patients are offered a free consultation. We also try to open all portals for patients to have their questions answered.

Denning: Practice administrators do not have to significantly alter their marketing programs because Crystalens marketing is an extension of LASIK marketing. The main difference is that advertisements include messages about intermediate and near vision.

Differences exist between LASIK patients and Crystalens patients. For example, LASIK patients are typically 40 years old, with 50% being women and 50% being men. Crystalens patients are, on average, 53 years old and 57% women. The technology is different in that LASIK delivers unifocal vision and Crystalens delivers seamless vision at all focal points, near, intermediate and distance. This results in an older patient base and marketing plans must be adjusted to meet the needs of this older market.

Chambers: In our practice, we have seen a 49% to 51% split between men and women. We have focused our marketing slightly toward the older age range. A marketing campaign that targets 40- to 65-year-olds is different from one that targets between 50- to 65-year-olds.

Doane: I agree. I come from a refractive surgery background, so initially my practice experienced some months where procedures performed were 80% refractive and 20% cataract and some months where it was the exact opposite. Our most recent month was at least 60% refractive and 40% cataract.

Denning: Marketers should not present LASIK and the Crystalens as comparable procedures. To the contrary, they are different procedures. The Crystalens provides patients with vision at all focal points and LASIK provides patients with vision at one focal point. By stating that the Crystalens provides patients with better vision, more value has inherently been placed on the Crystalens than LASIK. This explanation leads the way for a price differentiation because surgeons cannot perform a Crystalens procedure at the same price that they can perform a corneal refractive procedure. Therefore, it is important that staff understand that differentiation.

Prices

Wallace: What are you charging for these procedures? What is included in that charge?

Updegraff: George Waring, MD, said that he charges the same for refractive lens implants as for LASIK; however, the patient pays the surgical center additional costs for the nurse anesthetist and staff involved with the intraocular procedure. I feel this is a good way to reason with patients about the increased cost of the procedure.

Denning: Once intermediate and near vision is offered, the bar is raised and surgeons are committed financially to deliver a premium outcome. The value of the procedure should be priced accordingly. An extensive amount of non-covered technical work expense is involved with the preoperative process and postoperative process that are necessary to achieve satisfactory near, intermediate and distance vision. A surgeon is able to correct residual refractive error after conventional cataract surgery with a pair of glasses. With presbyopic cataract surgery, such as implantation with a Crystalens, surgeons are able to avoid residual refractive error with additional, non-covered testing and preoperative analysis.

Also, if patients are left with residual refractive error after implantation with a Crystalens, this will be corrected with additional surgery, not glasses. Non-covered procedures, such as conductive keratoplasty (Refractec, Inc., Irvine, Calif.) and LASIK, must be figured into the initial cost. The cost of implantation with a Crystalens is approximately $4,500 per eye. Of that global amount, approximately $2,300 is paid to the practice and $2,200 is paid to the facility for the actual cost of the Crystalens. The majority of surgeons experience the same expense. Implantation with a Crystalens is refractive presbyopic surgery, not just cataract surgery.

Personal experiences after bilateral implantation with the Crystalens J. Stuart Cumming, MD The surgical procedure was completely without discomfort. Additionally, postoperatively there was absolutely no discomfort. Immediately after surgery, my distance vision in the first eye was excellent, approximately 20/25. After the surgery on the second eye, my distance vision was again 20/25 at 1 day postoperative. I am currently 3 weeks postoperative and experience 20/15 in each eye individually and am able to read J2 bilaterally. I do not experience any glare at night, my intermediate vision is superb and I do not wear glasses unless I have to read small print for a prolonged period of time. I am delighted with the surgical outcome and have no hesitation recommending implantation with the Crystalens to family members and friends. J. Stuart Cumming, MD, FACS, FRCOphth, is the inventor of the Crystalens technology.

Whitman: Exact fees for the procedure depend on the region of the country. The price also depends on if a surgeon owns his or her own surgical center, what services the anesthetist or anesthesiologist has agreed to provide and how removal and replacement of the IOL, if necessary, will be performed.

Carter: Medicare has allowed the Crystalens procedure to be a private patient/payor circumstance in terms of the correction of presbyopia and other refractive services. It is largely through the efforts of eyeonics, inc. over the last 5 years that Medicare made this change. Medicare has always supported a patient’s right to choose treatments.

Chambers: I have seen an increase, as opposed to a decrease, in price for the Crystalens procedure in a number of practices after implementation.

Surgeons are asking a premium price and must be prepared to deliver premium services. Premium service can be defined as: less wait time for patients, more face time with patients and more effort to make sure that the patients are satisfied with their expected refractive outcomes, including any necessary enhancements down the line — all for a single price.

Certification process

Wallace: I know a number of you have been involved with the certification process. What can you tell me about it?

Doane: The certification process is important for multiple reasons. One, the Crystalens is a new technology with its own inherent issues that must be understood. Proper training is the only way to ensure that this is done. The process is centered around the lens and in dealing with this new type of refractive-minded IOL patient.

The proctoring that takes place for the first 20 Crystalens implantations ensures that emmetropia is achieved. If surgeons achieve emmetropia with their patients, the lens will do the rest. From a company standpoint it is important that the Crystalens implantation occurs flawlessly in the first 20 cases, otherwise surgeons will lose faith in the process.

Dell: A significant effort is put into physician certification courses. It is surprising how many surgeons enter the Crystalens certification process without the necessary tools for success. Biometry, astigmatism management, wound construction and the management of patient expectations are important components of the Crystalens certification course.

Whitman: Clinical application specialists from eyeonics, inc. help a surgeon decide what lens implant power to use in the first 20 Crystalens implantations. The application specialists are present at the surgery, the day after surgery and at 10 days postoperatively. There is an incredible commitment to making this work. However, it is not unreasonable to ask each surgeon to make this commitment to implanting 20 Crystalenses to determine how this lens functions and to achieve the highest level of IOL function.

Impact of Crystalens and the future

Wallace: What impact has the Crystalens had on your practice? Please discuss the future in terms of your practice and technology.

Denning: The financial impact of the Crystalens has been significant. In my practice, we receive approximately $5,000 per eye. If 30 to 40 eyes per month are implanted with the Crystalens, $150,000 in revenue is generated every month, which is between $1.8 and $2 million a year. The bottom line is: In an industry where between 1% and 2% of profits are cut each year, the Crystalens is a welcome addition. A practice the size of the one where I work would not be able to pay staff a market wage and equipment would not be replaced as often without refractive IOL technology.

Updegraff: The Crystalens has allowed us to offer a better quality of refractive care to our patients. Surgeons are not performing LASIK on patients with early nuclear sclerosis; but are instead moving immediately to the Crystalens. Last year, our practice experienced a 34% growth, which is unprecedented in a small business. Fifty percent of that growth was due to the Crystalens.

eyeonics, inc. IOL Registry Presented by Guy Kezirian, MD, FACS, at the ISRS/AAO 2005 meeting in Hong Kong, China. Crystalens’ manufacturer, eyeonics, inc., saw the need to gather outcomes from surgeons who routinely perform Crystalens implantations. They felt it was important to investigate the credentialing process and technology validation to confirm that post-approval results match the FDA trial outcomes. They also wanted to be able to detect problems that existed and to identify surgeons with results below normal levels. A final purpose was for research and development in general to identify opportunities to improve on the current results. Participation Registry began in October 2003 214 surgeons were given the software 137 (64%) surgeons have entered data Data Snapshot: 3/31/05 3225 eyes have been entered since 10/03 through preop exam Surgery has been entered on 2812 (87%) eyes “Required” postoperative is the 12-14 day exam - 1857 eyes have been (66%) entered Outcomes Clinical Outcomes - Refraction predictability (“Prediction Error”) - UCVA Reports are based on 3-month data (N= 814) Does the Crystalens accommodate? Patients with emmetropia have functional vision at both distance and near. This vision cannot be explained by residual astigmatism. Eyes with astigmatism saw worse than those with emmetropia. Distance and near acuities in eyes with residual postoperative error show results consistent with accommodation. Taken together, results indicate that the Crystalens accommodates. Comparison to FDA results DA results showed trends similar to registry data - Similar mean acuities for distance and near vision - Similar trend for improvement over time Distance UCVA of 20/40 or better - FDA: 89.1% - Registry: 85% (3 M) Near UCVA of 20/40 or better - FDA: N/A - Registry: 81% (3 M)

Chambers: One of the most important lessons that I have learned is that if a surgeon wants to become certified to implant the Crystalens, he or she should find a physician mentor who has had experience with the Crystalens.

Doane: I am enthusiastic about the future of accommodative IOLs. Accommodative IOL technology is only going to grow and improve.

Whitman: Accommodative IOLs will continue to advance the field of ophthalmology. Multifocal IOLs will not achieve what surgeons want because they produce a number of dysphotopsias that will not be acceptable in the future. Surgeons will obtain the best refractive surgery results with lens implants that provide adequate accommodative function.

Wallace: To conclude our discussion today, I would like to summarize some key points. Crystalens has had a positive impact on our practices and, in turn, this has resulted in positive patient outcomes. Many of the strategies that led to the successful adoption of Crystalens into our practices are sound medical approaches that can be utilized by any ophthalmology practice. Proven strategies include: selecting ideal patients and, therefore, the correct lens for each patient; managing patient expectations with proper preoperative counseling and accurate IOL-power calculations; performing surgeries with exquisite skills, including astigmatism reduction; and guiding each patient through his or her postoperative period to better full spectrum vision.

References

1. LASIK Eye Surgeons and Eye Surgery Information. The Council for Refractive Surgery Quality Assurance. Available at www.usaeyes.org/faq/subjects/crystalens.htm. Accessed on March 22, 2005.
2. Can be found at: www.fda.gov/cdrh/pdf3/p030002.html.