The New IOLs: Comanage with Confidence

Be your cataract patient’s advocate in deciding on premium intraocular lenses, and then stay involved in the patient’s care.

By Paul C. Ajamian, O.D., F.A.A.O.

Goal Statement:

In about a decade, the number of baby boomers in retirement age will swell to more than 50 million. New designs in elective presbyopia-correcting intraocular lenses now give these patients options for refractive correction at the time of cataract surgery. This article assists the optometrist in performing an expanded role as a trusted advisor to patients who are considering the various IOL options associated with cataract surgery.

Faculty/Editorial Board:

Paul C. Ajamian, O.D., F.A.A.O.

Credit Statement:

This course is COPE qualified for 1 hour of CE credit. COPE ID 23694-RS. Check with your local state licensing board to see if this counts toward your CE requirement for relicensure.

Joint-Sponsorship Statement:

This continuing education course is joint-sponsored by the University of Alabama School of Optometry. This course is supported by an unrestricted educational grant from Alcon.

Disclosure Statement:

Dr. Ajamian is on the speakers’ bureau for Allergan, Alcon and VSP.

---

Remember the good old days? As primary-care doctors of optometry, we would diagnose a patient with cataracts, then send them to our surgeon of choice for lens extraction and implantation of an intraocular lens (IOL). There was one kind of surgery and one implant option, so no lengthy discussion was necessary. The patient was told that the cloudy lens would be removed and a replacement lens inserted to correct for distance but not for reading. After two to four weeks, a bifocal prescription was written, the vision improved, and the patient was happy. Or so we hoped, because there were no other options available.

In 2005, two events occurred that changed the picture dramatically. First, several companies introduced newer generation presbyopia-correcting intraocular lenses (PrC IOLs). Second, the Centers for Medicare and Medicaid Services (CMS) ruled that patients could be charged for premium services (deemed “non-covered” by Medicare), allowing patients to pay out of pocket for these “new technology” lenses. For those interested in spectacle freedom, there were now several options to consider.

The Array IOL (Advanced Medical Optics [AMO]), which was first approved in the late 1990s, had been redesigned, and was reintroduced in 2005 as the ReZoom. The Crystalens (Bausch & Lomb Surgical) was launched in 2003 as the first “accommodating” IOL, and the AcrySof ReSTOR (Alcon) was introduced in 2005 with a unique diffractive technology to correct for distance and near.¹ All three lenses were a big improvement over the original Array IOL design. None are perfect; all have their strengths and weaknesses. But you need only ask the patients who have chosen them to quickly learn that most think it’s the best money they ever spent. In addition, the relatively new AcrySof Toric IOL (Alcon) can reliably eliminate spherical and cylindrical error in one procedure, with no limbal incisions, and is extremely stable over time.

But who is a candidate for these lenses, and what is the incentive to spend valuable chair time discussing them?

This article summarizes the state of the industry as we enter 2009, and is meant to assist you in maintaining your role as a trusted advisor to patients who are considering the various IOL options associated with cataract surgery. Most doctors of optometry are quite comfortable with refractive surgery. The new IOLs represent the blending of a refractive procedure with traditional cataract surgery. Getting up to speed is essential, and not difficult to do. We have heard it over and over again, but by the year 2020, the population of American baby boomers over age 65 will swell to more than 50 million.² With the demand that will be placed on our surgeons, our role in comanaging cataract surgery patients will continue to expand significantly.

AcrySof ReSTOR

This lens, using the same platform as the AcrySof monofocal lens, is based on the optical principle of apodization, a series of graduated steps that result in diffraction of light at distance and near. The power of the current lens is +4.00D, effectively a 3.20D add in the spectacle plane. A new +3.00D version, launched recently outside the U.S., will translate to approximately a 2.40D add in the spectacle plane, thereby increasing the reading range. It will be available in the U.S. in the first quarter of 2009, according to the company.

A significant advantage of the ReSTOR lens is how well it corrects reading vision while maintaining good distance acuity.³ With the new +3.00D lens, performance in the intermediate range will continue to improve as well.

As with any of the multifocal lenses, there is the potential for glare and halos at night. The aspheric ReSTOR, which has effectively replaced the original spherical ReSTOR lens, has reduced the incidence of significant symptoms while improving contrast sensitivity.⁴

ReZoom

This lens, a modification of AMO’s Array, consists of alternating refractive zones that correct for either distance or near.

The center optical zone corrects for distance, the next zone for near, the next for distance. Because of a near add that is effectively 2.50D in the spectacle plane, this lens provides good acuity in the intermediate range. Distance vision is good, but glare at night is more of a problem than with the other lenses.^5-7

Measuring pupil size is important when evaluating a patient for this lens as a small pupil will focus light through the central distance zone, resulting in sub-optimal near vision. Minimum pupil size is 2.5mm, but above 3.5mm is ideal.

Crystalens

The Crystalens is currently the only FDA-approved accommodative lens. It is hinged so that it can change position inside the eye as the patient looks at a near target. Distance vision is probably the sharpest with this lens because, similar to a monofocal lens, the surface of the lens is smooth. The initial “wow” factor at distance and intermediate ranges is good, but the lens only provides a near add of 1.50D to 2.00D, and this can decrease over time. These patients will likely need glasses to read. The lens has gone through a number of revisions. The latest version is called the Crystalens HD, with a new design to the central optic to improve near acuity.

As with all the PrC lenses, further studies are needed to determine the strengths and weaknesses of each lens.

Mix and Match

Because each of the PrC lenses has strengths and weaknesses, some surgeons have “experimented” with various combinations of lenses to come up with the best range of vision for a particular patient’s needs.

The most frequently used combination seems to be ReSTOR/ ReZoom, which is basically a modified form of monovision that targets one eye for near and one eye for intermediate vision.⁸ The choice of which combination and when to implant them seems to be more of an art than a science at this point. Combining different lenses could present a whole new set of problems related to visual distortion and stereopsis, although many surgeons anecdotally say that these patients are very happy.

A number of other surgeons are holding steadfast to the original concept that the lenses are designed for bilateral implantation, and there should be no mixing and matching until clinical studies prove otherwise.⁹

The Toric IOL

Astigmatism can be a problem if the patient would like to be spectacle-free at distance following cataract surgery. For small amounts of corneal cylinder (1.00D to 1.50D), limbal relaxing incisions are quite successful. Lesser amounts can be corrected by carefully locating the incision site. Greater amounts require other measures.

The AcrySof Toric IOL is rapidly gaining favor as a lens option for these patients because of its rotational stability and accurate correction of astigmatism.¹⁰ Surgeons use an online calculator to determine the exact axis and power. The balanced billing rule was applied to this lens in 2006. The patient price is significantly less than a premium presbyopic lens, making it an attractive option for many patients. If the astigmatism is above 3.00D, which is the maximum that this lens corrects at present, limbal relaxing incisions or a refractive laser procedure can be combined with the toric lens to more completely eliminate astigmatism.

Patient Selection

Getting on the “same page” as your surgeon is critical as you incorporate premium IOLs into your practice. You can talk about the lenses all you want, but if your surgeon doesn’t use them, it’s all for naught. While there are still a number of surgeons who haven’t yet embraced this technology, it would benefit you and your patients to find one who does.¹¹ At the same time, be sure that the surgeon works well with optometry, and that his or her surgical skills are top notch. Expect to see your patients for their postoperative visits, unless there is a complication or a good reason not to. Expect timely communication from the surgeon’s office, and likewise keep the surgeon informed of each patient’s progress. Expect nothing but the best customer service for these patients. They are spending a lot of extra money and expect a great deal in return.

So, who do you mention the premium lenses to? The answer is: everyone. You no longer have a choice. The lenses need to be consistently presented, but certainly not pushed. Even if not a candidate, your patients should know this technology exists.

Patients who are highly motivated to reduce their dependence on spectacles, but who know there are no guarantees, are the best candidates. Patients can be hyperopic or myopic, but if they have any cylinder over 0.50D, that needs to be addressed via incisional or refractive laser correction.

Those cataract patients who are considering LASIK or have thought about it in the past may be excellent candidates, as you can promote this procedure as a “two-for-one” (i.e., cataract and refractive surgery) without touching the cornea.

Many patients who have already had LASIK are now developing cataracts. They were originally thought to be off-limits for a multi-focal IOL, but some doctors will now consider these patients on a case-by-case basis. LASIK patients with cataracts present a particular challenge, regardless of the IOL chosen, because their pre-op K readings are rarely available and formulas must be used to extrapolate the final lens power.¹² In the end, a patient must be warned of the risks, and if the outcome is unacceptable after an adaptation period, then the lens can be explanted and a monofocal IOL put in.

Patients will also present with a history of a monofocal IOL in one eye and a symptomatic cataract in the other. The initial school of thought was that this patient was not a candidate for a multifocal IOL. More and more surgeons now consider a PrC lens in this eye, often with good results.¹³

The Evaluation

Pay particular attention to the degree of astigmatism in your potential premium IOL patients. For the best visual result, most if not all of the cylinder needs to be eliminated. Using limbal relaxing incisions at the time of surgery can eliminate up to 1.50D, depending on the surgeon. Astigmatism above this is typically a contraindication for multifocal IOLs until a lens like the AcrySof ReSTOR Toric, now in the pipeline, is approved.

Patients with any macular problem or distortion, such as a preretinal membrane, are not good candidates. Patients with a potential for a macular problem, such as those with diabetes or a history of cystoid macular edema, should only have this lens put in after careful discussion of the risks and benefits with the patient and family.¹⁴ Preoperatively, ocular coherence tomography (OCT) is always a good baseline test to have in the patient’s chart. Any patient with moderate to advanced glaucoma should not be considered a candidate for this lens. If significant blepharitis or dry eye is noted, treat the patient and get it under control prior to sending the patient for surgery. Any other corneal or anterior segment abnormality can affect outcomes as well. Corneal topography can be a valuable diagnostic tool in these cases.

The Money Talk

Too often, we present options based on what we think the patient can afford. Don’t assume anything when it comes to your patient’s finances. Have the same discussion with everyone, and let them decide. First, present the patient with a brief description of the premium lenses available and the additional out-of-pocket charges that cover the cost of the lens and the additional work necessary, and then let the patient tell you if they are interested.

It is important to mention that the premium lenses provide the advantage of greater range of vision, and less dependence on spectacles. Explain that, while Medicare has recognized the value of these lenses, it will not pay for the upgrade and there will be a significant cost to the patient that insurance will not cover. Medicare will pay for the basic procedure, so be ready to file the modifier 55 while the surgeon files the modifier 54, indicating surgical care only. As with LASIK, a comanagement fee over and above this is customary in order to cover your additional time and effort.

Education and Expectations

Patient education is critical for these IOLs. It begins by informing your staff of the various options. Holding in-office seminars is a key component to increasing staff buy-in, along with tapping into online and printed resources that can be used by staff and patients alike.

In addition to patient education, we must also properly manage our patients’ expectations. Tell all patients that they will probably need to wear some form of correction at one time or another after surgery, depending on lighting conditions.

The surgeon’s practice is an extension of your own, and it is important to convey a consistent message with consistent instructions. The better you know the surgeon’s protocols, the more seamless the experience will be. It’s a very good idea to make appointments for your patients, and communicate your results and your refractive goals to the surgeon in writing ahead of those appointments. This not only insures a proper outcome, but also protects you medico-legally. Giving patients a phone number and asking them to call and set up “surgical consult” for a “premium IOL” can lead to confusion and unintended results. Stay involved in the patient’s care. Don’t just refer and forget!

Post-op Visits

Doctors of optometry are experienced in post-op cataract management. Most patients, if given the choice, would probably rather see the doctor they are most familiar with for their post-op visits. The surgeon’s office should schedule the one-day post-op visit in your office if clinically appropriate, and then you schedule the rest.

Premium lens patients are no more complicated to see after surgery than conventional monofocal patients. Remember that this is a bilateral procedure in most cases, and the vision will be much better once the second eye is done. If there are any significant problems after the first eye, consult with the surgeon and consider postponing the second eye until the vision is stable.

Post-op Exams for Cataract Patients Here is a typical post-op schedule (monofocal or premium IOL) and what to look for: Post-op Day One and Post-op One Week Check the unaided acuity: if not 20/20, perform a quick refraction. Examine corneal incision. Grade the amount of cell and flare in the anterior chamber (typically trace to 2+ cells and minimal flare). If acuity is worse than 20/40 and cornea is clear, consider dilation. Check IOP: If it’s higher than 30mm Hg, consider a temporary anti-glaucoma medication (avoid prostaglandins). If it’s higher than 40mm Hg, consider alleviating pressure by “burping the wound” via paracentesis site. Post-op One Month Same as above with the addition of routine dilation, fundus exam and final refraction. If vision is not correctable to 20/20 at this visit, look for: Ocular surface disease (vision fluctuating). Posterior capsular opacification. Cystoid macular edema.

Even after both eyes are completed, expect some patients to get “buyer’s remorse” and complain that their near vision is not as good as they expected. Simply place a pair of -3.00D lenses in front of them and tell them that is how they would have seen up close without the new PrC lenses. It works!

Beware that ocular surface disease can significantly affect the performance of these lenses, so keeping the cornea and anterior segment lubricated and healthy is an ongoing challenge. Patients are also more sensitive to capsular opacification, prompting earlier YAG capsulotomy. As with any cataract patient, be vigilant for cystoid macular edema.

A New Day Dawning

Premium IOLs present a great opportunity for doctors of optometry and their patients. Discuss the new lens options with enthusiasm and confidence. There is a lot to be excited about! Toric lenses can eliminate large amounts of astigmatism. The presbyopic-correcting lenses can free up patients with active lifestyles who are interested in less dependence on glasses. Don’t prejudge and make decisions for them; just give them the facts and then guide them down the path that will best achieve their goals.

Direct your patients to a surgeon who uses the new lenses and will partner with you in providing the best care. You should recommend the best surgeons, not the closest. You should refer patients to colleagues who welcome your opinions. You should look for partners to comanage with, rather than practices to unload patients on.

The “good old days” were good, but the days ahead will be better, with more technology and more options for our patients. Be their advocate, be the expert, and most importantly be involved in their surgical care from the beginning to the end.

Dr. Ajamian is the Center Director of Omni Eye Services of Atlanta, General Chairman of the SECO International CE Committee, and editor of Review’s “Comanagement Q&A” column.

References

1. Quinn C, Mastrota K. New frontiers in IOL technology. Rev Optom 2008 Mar;145(3):105-11.
2. Himes CL. Elderly Americans. Population Bulletin. 2001 Dec;56(4):8.
3. Chang DF. Prospective functional and clinical comparison of bilateral ReZoom and ReSTOR intraocular lenses in patients 70 years or younger. J Cataract Refract Surg 2008;34:934-41.
4. Alphonso JF, et al. Visual Performance after Acrysof ReSTOR aspheric intraocular lens implantation. J Optom 2008;1:30-35.
5. Tipperman R. Pinhole image comparison with white light source for 3 multifocal lens designs. Poster presented at American Society of Cataract and Refractive Surgery (ASCRS) Symposium on Cataract, IOL and Refractive Surgery, April-May 2007; San Diego.
6. Schwiegerling J, Ye X, Choi J, Ernest P. Night-time visual quality with different multifocal IOLs. Poster presented at Annual Meeting of the European Society of Cataract and Refractive Surgeons, Sep 2006; London.
7. Chang DF. Prospective functional and clinical comparison of bilateral ReZoom and ReSTOR intraocular lenses in patients 70 years or younger. J Cataract Refract Surg 2008 Jun;34(6):934-41.
8. Pepose JS, Qazi MA, Davies J, et al. Visual performance of patients with bilateral vs combination Crystalens, ReZoom, and ReSTOR intraocular lens implants. Am J Ophthalmol 2007 Sep;144(3):347-357.
9. Solomon KD. Why not to mix and match IOLs. Cataract & Refractive Surgery Today 2006 Mar:99-101.
10. Lane S. The Acrysof Toric IOL’s FDA trial results. Cataract & Refractive Surgery Today 2006 May; 66-68.
11. Patterson L. The challenge of presbyopic IOLs. Ophthalmology Management 2008 Mar;12(3):4.
12. Wang L, Booth MA, Koch DD. Comparison of intraocular lens power calculation methods in eyes that have undergone LASIK. Ophthalmology 2004 Oct;111(10):1825-31.
13. Jacobi PC, Dietlein TS, Lüke C, Jacobi FK. Multifocal intraocular lens implantation in prepresbyopic patients with unilateral cataract. Ophthalmology 2002 Apr;109(4):680-6.
14. Mainster MA, Turner PL. Multifocal IOLs and Maculopathy: How Much is Too Much? In: Chang D, ed. Mastering Refractive IOLs: The Art and Science. Thorofare, NJ: Slack Incorporated; 2008:389-392.