Make Your Premium IOL Practice Blossom

As new technology and surgical advances improve outcomes, this category is ready for growth

By René Luthe, Senior Associate Editor

Despite years of marketing, the premium IOL category in the United States has not exactly boomed — according to MarketScope, the number of such IOLs implanted here hovers at around 7%. Ask surgeons why they think this is so and the most frequently mentioned reason you'll hear is the difficulty of delivering the uncorrected refractive outcomes that patients expect. Particularly when patients are paying higher fees out of pocket for premium IOLs, they want excellent results.

However, thanks to new technologies and better surgical procedures from doctors who have learned to hit the refractive target, many experts do expect premium IOLs to reach their much-discussed potential. Here's a look at several ways you can nurture your own premium IOL practice.

New Tools

A few new devices allow cataract surgeons to fine-tune outcomes for their patients. Below are first-hand accounts of the benefits that can be achieved by several new tools.

■ WaveTec Vision's ORange intraoperative wavefront aberrometer. Launched in 2009, intraoperative wavefront aberrometry provides real-time refractions during surgery and allows surgeons to make adjustments "on the fly." Attached to the operating microscope, the ORange captures refraction in two to five seconds, measuring sphere, cylinder and axis and displaying the results on a computer screen.

The information provided can improve the accuracy of toric lens positioning or limbal relaxing incisions as the procedure dictates. It can also allow the surgeon to choose a different IOL than originally intended if the wavefront analysis suggests that is necessary. And in a world where many cataract patients were previously refractive surgery patients, the ORange is capable of taking refractive measurements through a post-refractive cornea. It can confirm the refractive status of an eye immediately after IOL implantation, including phakic IOLs.

Mark Packer, MD, of Portland, Ore., uses the ORange to enhance the effects of limbal relaxing incisions at the time of cataract surgery. He reports that it has reduced his postop excimer laser enhancement rate from 16% to 3%. A recent update gives the ORange the capability of providing IOL power calculation at the time of surgery in the OR.

"It's useful as a check for us to examine the power. And that's in normal eyes," Dr. Packer says. "But the place that it's really critical is in the post-LASIK eye, where all of our methods kind of fall apart because the topography and keratometry are unreliable. But measuring the wavefront of the aphakic eye, during surgery, has now been shown to give a more accurate IOL power calculation."

■ Haag Streit's Lenstar. The Lenstar gives nine measurements in one sitting, and can measure central corneal thickness, anterior chamber depth, lens thickness and axial length, keratometry, corneal diameter, pupil size, eccentricity of the visual axis line and retinal thickness. It can provide all seven required measurements for the Holladay 2 IOL calculator without using other apparatus, saving labor. "The new Lenstar software has the Holladay 2 equation built in to eliminate transcription errors from manual entry," says Uday Devgan, MD, in private practice in Los Angeles.

He has only had the device for a few months, so while he feels that his accuracy is improved, it is still too early to do a statistical comparison to see if it has affected his enhancement rate. "For me," Dr. Devgan says, "part of the biggest benefit is having the Holladay 2 equation available. Because in unusual eyes — eyes that have a shorter axial length or eyes that have a flatter cornea — the Holladay 2 ends up being a more reliable equation."

■ Femtosecond laser cataract surgery. FS lasers allow surgeons to create a very precise capsulorhexis, which helps in securing the desired effective lens position, says Dr. Devgan; failing to achieve proper positioning is a significant source of IOL power error. The laser also allows the surgeon to create very reproducible incisons.

"Remember, every incision in the eye has some effect on astigmatism," Dr. Devgan says. "So the smaller the incision, the less the effect. The way the incision is constructed also can lessen the effect. You can have a very predictable incision architecture with a femtosecond laser, each and every time." The result, he says, is, theoretically, a more accurate refractive outcome.

LenSx received the first femtosecond laser clearance for a cataract surgery indication in August 2009 for anterior capsulotomy, followed by a clearance for corneal incisions in December and recently one for laser phacofragmentation during cataract surgery. OptiMedica and Lensar also are developing femtosecond lasers for cataract surgery.

Houston's Stephen G. Slade, MD, performed the first laser cataract surgery cases in the United States using a LenSx femtosecond laser. According to data presented by Dr. Slade at the recent ASCRS meeting, all 19 eyes in his study achieved BCVA of 20/30 or better, with 75% achieving 20/25 or better, and 25% achieving 20/20 or better.

"Hopefully there will also be other indications soon, such as making limbal relaxing incisions," Dr. Devgan says. "I am looking forward to using the femtosecond laser to chop up the cataract nucleus, so that you don't even have to use phaco energy or a phaco chop technique. The cataract is already chopped up, you just put the suction probe in and suck out the pieces."

In the Here and Now

Many of these innovations may not yet be widely available, or may be cost prohibitive for small practices, but take heart — experts say there is much cataract surgeons can do with the equipment they probably already have access to. A thorough preoperative evaluation is at the top of the list for improving outcomes for premium IOLs. William B. Trattler, MD, of Miami, describes it as the first step to being successful with the lenses.

Stephen A. Updegraff, MD, in private practice in St. Petersburg, Fla., agrees. "There are many surgeons I spoke with at ASCRS who do premium IOLs who share a similar concern with me that you could potentially have a plethora of very unhappy patients paying for a premium service, but one which the doctor could not deliver on because they didn't do the preoperative screening and the management of that patient postoperatively," Dr. Updegraff says. "You have to screen patients like you would a LASIK patient."

Jay S. Pepose, MD, PhD, professor of clinical ophthalmology at Washington University in St. Louis, says that in the preoperative phase, it is crucial that the doctor get any contact-lens wearing patients out of their lenses for a sufficiently long period of time before keratometry readings so that the effect of lens warpage is obviated.

Additionally, corneal topography should be performed to look for signs of irregular astigmatism from anterior basement membrane dystrophy or forme fruste keratoconus, which could affect the IOL's performance. He also recommends testing the patient's potential retinal acuity. "You want to avoid postop surprises like macular degeneration, epiretinal membranes or diabetic macular edema because these would also negatively impact IOL performance."

Dr. Trattler urges careful screening for conditions such as dry eye and blepharitis. According to a study he presented at last month's ASCRS meeting, blepharitis was present in 59% of a sample of 100 patients about to undergo cataract surgery.¹ Patients' signs and symptoms were determined to be mild or moderate, which the investigators speculate was the reason the disease was missed.

Preop blepharitis or dry eye, when encountered, must be treated aggressively to get under control before surgery, Dr. Trattler says. And using topography further helps eliminate the possibility of unpleasant surprises after surgery. Dr. Updegraff adds pachymetry and endothelial cell counts to the list of presurgical screening measures.

"Doctors who are trying to get into premium IOLs need to know that this preoperative work must be done," explains Dr. Trattler. "I do it routinely and know of other surgeons who do, and they tend to be the more successful ones."

Surgeons agree that the work pays off. "I had a referral where the doctor didn't look at the topography; the patient had keratoconus and there was no exit strategy, other than wearing an RGP," Dr. Pepose says. "The patient said, ‘Why did I spend a few thousand dollars to wear a contact lens?’"

Dr. Pepose adds that his own recent research has shown him that performance of multifocal IOLs is dependent upon pupil size. "It's not just in terms of the distribution of light between near and far, but also in terms of how sharp the image would be at near and far and how much light will be lost to useless foci," he explains.

Thus, he says, it is crucial to know the patient's pupil size and pupil dynamics. "Is this a patient who is sort of stuck at 2 mm and the pupil size never varies, or is it someone who has a pupil of 2 mm in bright light but when they're driving at night the pupil is 5 mm. The performance of some of these lenses and the quality of vision would vary tremendous ly for near, intermediate and far."

It is also in the preoperative stage, Dr. Pepose says, that the surgeon should assess whether the patient is a candidate for refractive surgery, should an enhancement be required.

Preoperative evaluation is critical because many patients have coexisting pathology, notes David R. Hardten, MD, adjunct associate professor of ophthalmology at the University of Minnesota. Macular degeneration, Fuchs' dystrophy, epiretinal membrane or previous retinal detachment are all conditions that suggest the patient may be better off with a monofocal implant and glasses for near vision after surgery. "I think coexisting pathology is one big factor in why premium IOL penetration isn't higher," he says.

A laser-cut capsulorhexis (a) provides greater precision and reproducibility. This perfect placement of the capsulorhexis ensures that the lens positioning (b) is ideal.

Intraoperative Strategies

Probably the most important intraoperative issue to improve premium IOL outcomes is correction of astigmatism, according to Dr. Packer. "You need to reduce the astigmatism to below 1 diopter, maybe below even 0.75 diopters," he says. "And so you need a plan, because about 30% of patients will need something done about their astigmatism so they can see clearly. Without that, the technology just doesn't fly." Limbal relaxing incisions are the usual way to handle astigmatism, he says, but concedes that those have a reputation of being somewhat unpredictable.

Dr. Pepose says that surgeons can improve their premium IOL outcomes by standardizing their approach. "It's critical — make the capsulorhexis the same, do the procedure the same, try to make things as uniform as possible."

Predictable and reproducible incisions are a key component to achieving astigmatic accuracy, agrees Dr. Devgan. To make incisions more reproducible is a matter of having the correct blades the surgeon desires, as well as a uniform lens architecture with a consistent tunnel length. To determine the astigmatic effect of the phaco incision, Dr. Devgan recommends examining the last 10-20 patients on whom you have performed cataract surgery and looking at keratometry measurements before and after the procedure.

"If I know what the cornea measurement was before surgery, and I know what the cornea measurement is after surgery, and I know where I made my incision, I can say that, on average from my last 20 patients, my cataract incision caused this much astigmatic flattening at the meridian that it was made," he explains. "For the average cataract incision of 2.8 mm, it's about a half of a diopter flattening at that meridian." In microincisional phaco, with its 2-mm wide incisions, Dr. Devgan finds approximately 0.25 to 0.3 diopter of flattening.

In order to make the capsulorhexis more reproducible, Dr. Devgan uses a forceps of his own design. The capsulorhexis forceps have two marks on them, one 2.5 mm from the tip and another at 5 mm so that he can measure the capsulorhexis as he makes it. Another method is to use a round marker and, at the beginning of surgery, make a light indent on the cornea. The surgeon would then attempt to trace the capsulorhexis to the size of the indentation. "These are good initial steps until we have widespread availability of femtosecond lasers for cataract surgery," Dr. Devgan says.

He adds that surgeons need to be very careful not to rupture the posterior capsule. "Part of the reason is that a lot of the premium lenses cannot be easily implanted in an eye with a ruptured posterior capsule," Dr. Devgan explains.

Postop Work

Dr. Hardten says that he finds postop premium IOL management "extremely interesting." Preop screening is done for all cataract patients, but presbyopic IOLs and astigmatism management require what Dr. Hardten calls a lower tolerance for coexisting pathology in this postoperative phase.

"You have to have a lower tolerance for doing a YAG capsulotomy, because small amounts of posterior capsular opacity bother the patient more when they have had presbyopic or astigmatic correction," he explains. "You have to have a lower tolerance for managing cystoid macular edema because small amounts of CME affect these patients visually more, so we use our non-steroidals a bit longer and work on the tear film a bit more by using cyclosporine, tears and plugs more often. Also, managing residual refractive error through corneal laser vision correction is very important."

Dr. Pepose agrees that it is an important phase to address in order to help the premium IOL live up to patient expectations. This is where the refining process begins. "You have to measure the outcome postoperatively, then go back and refine the A-constant, which is a ‘fudge factor’ in determining what power lens the surgeon will implant," he says. "By adjusting the A-constants, you're going to get better. You're getting better in terms of the average, but you also have to look at the standard deviation."

Last But Not Least: Patient Education

Technological innovations and surgical techniques can go a long way toward helping premium IOLs be all they can be, but cataract surgeons caution that good old-fashioned communication skills are still essential to success with premium IOLs. Providing the optimal outcome for patients begins with the counseling process, says Dr. Hardten.

Patients often think getting a premium IOL will be like wearing contact lenses or glasses, Dr. Updegraff says, and they need to be disabused of that notion. The surgeon must make clear to them that premium IOLs mean a commitment to more office visits for preoperative testing and postoperative evaluation, with the higher fees that the extra time with the surgeon entails. They also need to know that each premium IOL has its advantages and disadvantages.

After listening to all the caveats, Dr. Hardten reports that some patients conclude, "Gosh, this is a lot of work. I just want my cataract out!" When patients have suffered vision loss from their cataracts over a period of a few years, many are simply concerned with getting that vision back and aren't interested in all the considerations that go along with signing on for a premium IOL.

Dr. Hardten says that in his experience, the older a patient is, the more likely he or she is to choose a monofocal. "It's not just the cost factor, it's often the hassle factor," he explains. "They don't want extra office visits to check for potential problems, like the higher YAG capsulotomy rate or enhancement procedures for presbyopic or toric IOLs."

Yet even for the younger, active patients who tend to be willing to take on the extra work premium IOLs require, communication and people skills are necessary. "Being a premium IOL surgeon is a lot like being a refractive sur geon," Robert Maloney, MD, a private practice refractive surgeon from Los Angeles notes. "It's the same skill set." Like LASIK, it requires managing patient expectations.

The first among those expectations, Dr. Maloney says, is that patients should consider an enhancement a distinct possibility. Patients need to know that the surgeon may not achieve the desired refractive outcome on the first try. Second, patients must be made aware that in a small number of cases premium IOLs are not tolerated by the eye and lens exchange may be required. The bottom line is that the process may not be over when the IOL is implanted.

"You've got to tell the patient that if we don't reduce your astigmatism or if we don't hit the target right on, we may need to do other things," Dr. Pepose says. "We may need to do a YAG capsulotomy, we may need to do a laser vision correction, whether it be a surface treatment or LASIK." This means that going into the surgery preoperatively, the surgeon must assess whether the patient is a candidate for LASIK or PRK. "Because you don't want to tell the patient afterward, ‘I recommended this lens, we didn't hit the target and by the way, there's no good way to improve the outcome other than glasses or a contact lens.’"

Dr. Pepose agrees, and cautions that the patient could lose confidence in the surgeon if not informed beforehand that reaching the visual goal could be a multi-step process.

Dr. Updegraff shares their caution. "I believe there's a danger in making patients, or certainly surgeons, feel that their success solely lies in IOL accuracy. There's a whole other piece of this and that has to deal with the cornea and management of dry eye, ocular surface disease and these little micro corrections that can really affect the quality or the maximum efficiency of that IOL." Many of these patients, he warns, will still require bioptics or PRK, depending on what procedure they are a candidate for.

As in refractive surgery, however, careful counseling does not always eliminate the possibility of unhappy patients postop. What is needed in these cases, Dr. Maloney says, is a combination of medical and psychological care. "It's about being available, being responsive, direct and honest, not being defensive. These are skills we refractive surgeons have learned over the years, and have the battle scars to prove it."

Good patient education requires that the surgeon has realistic expectations of premium IOLs as well.

Accepting the Enhancement Bargain

"Refractive accuracy is critical" for successful premium IOL outcomes, Dr. Maloney says. But that's not an easy thing to achieve with these lenses. Even with the help of the IOL Master, Dr. Maloney points out, the standard deviation of the refractive accuracy is approximately plus or minus 0.6 diopter. "Well, that's a pretty good-sized error, particularly in terms of what we're used to nowadays with our LASIK results," he says. "And premium IOLs just don't work well unless you get the refraction spot on."

Even with the aid of innovations and careful preoperative evaluation, getting that refraction "spot on" often requires an enhancement after the initial surgery. "One of the biggest issues is that after surgery, a lot of patients are left with residual refractive errors, even in the best of hands," Dr. Packer says. He advises surgeons to expect an enhancement rate of 10% to 20% of premium IOL patients.

Dr. Maloney's 15 years as a refractive surgeon means that he is comfortable taking patients into his laser suite and performing an enhancement. However, he notes that some surgeons are struggling because they have neither the access to a laser nor the experience with laser refractive surgery.

Dr. Pepose concurs, adding that ophthalmologists who have not done laser vision correction surgery may not be comfortable talking with patients about the fees involved.

"It involves saying to patients, ‘this is not a covered service and this is what the costs are for the added value associated with the implantation of a presbyopia-correcting IOL.’ But some cataract surgeons are used to the insurance model and may feel less comfortable with the other model, particularly when you compound that with surgeons who don't have much experience or ready access to a laser not being too confident about getting the outcome they want."

Finally, Dr. Maloney notes that it is important the surgeon know when not to use premium IOLs. "We've seen problems when multifocal IOLs are used in patients with previous LASIK or PRK," he says, "particularly if the original LASIK or PRK correction was moderate or high and if there are aberrations that were induced by the original surgery. So I tend to counsel physicians to avoid multifocal lenses in post-refractive eyes."

Quality vs. Quantity

It is also important that cataract surgeons are aware that a successful premium IOL practice will require much more chair time with the patient — again, more like a refractive practice than the typical high-volume cataract model.

"It changes from being about quantity to being about quality," Dr. Packer says. "That's a fundamental change in mindset that is a stumbling block for cataract surgeons. You have to get past the idea that it's going to take an extra three minutes in the operating room to get these measurements and to act on them."

In short, new IOLs and ancillary tools do not make success with premium IOLs a sure thing. "All those new devices are fantastic to decrease our retreatment rate, but we should never give the patient the impression that we've got it so dialed in on that end that they are not going to have to worry about that," Dr. Updegraff says. "We're not there yet, and I don't know if we'll ever be. I hate to say that, and perhaps we will get there with lasers that can create a perfect capsulorhexis. But right now, that's where we are."

Even so, many surgeons believe premium IOLs are worthwhile for the excellent vision they can deliver. "It takes more time to get them right," Dr. Packer says. "But you have to keep in mind what the goal is, and that is that we want this person to get the best possible result." OM

Reference

1. Luchs J, Buznega C, Trattler W. Incidence of blepharitis in patients undergoing phacoemulsification. Paper presented at American Society of Cataract & Refractive Surgeons Annual Meeting; April 9-14, 2010; Boston.