Why is multifocal IOL acceptance so slow and difficult in Europe?

OSN Europe/Asia-Pacific Edition Associate Editor Matteo Piovella, MD, discusses the reasons for this lag in Europe.

ByMatteo Piovella, MD

Multifocal IOLs are a great advancement. They rejuvenate vision in cataract patients, as well as free younger refractive lens exchange patients, especially hyperopes, from spectacle use. They have improved over the years with increasingly fewer problems and offer, through the mix-and-match option, good vision at all distances, including intermediate.

Matteo Piovella

Why then, I wonder, are they still such a small part of the total number of implanted IOLs? Why are so many surgeons in Europe so reluctant to use them? Why do the detractors of multifocal IOLs greatly outnumber the supporters?

In the past year, I have used multifocal IOLs in 39% of my patients with great satisfaction. My patients are happy when they come back for follow-up visits because they have achieved what they wanted and have tremendously improved their quality of life. They are grateful to me because I have offered them this option.

Certainly, these patients have required more of my time and a lot of extra care. I work in a private practice and have the freedom to decide how much time I want to give to my patients and how much money I want to invest in my equipment. Working in a private clinic also gives me the option of whether or not I wish to offer my patients more expensive options (multifocal IOLs, in this case) for better quality outcomes.

Private practitioners do not have an easy life in Italy, but that is another story for another day. What I want to stress now is that at least we have the freedom to decide what is best for our patients (to the limited number of patients, of course, who can afford to come to us).

Overloaded, overworked, underpaid

The same does not apply to my colleagues who work within the National Health Service (NHS), in public hospitals or in conventional clinical practices.

In most European countries, public medical institutions have suffered for years because of chronic staff shortages. Doctors are increasingly overloaded with patients, duties, tasks (including a great amount of bureaucracy) and responsibilities. They see more patients per hour and do more surgery per hour, but are paid less per unit of work and have lost social and personal recognition. In addition, they have to deal with an increasing number of lawsuits.

In other words, they are under a lot of stress, are overworked, have lost motivation and therefore fear, rather than welcome, any new technology as a source of increased burden and potential problems, with little to earn in return.

Cataract surgeons in particular will identify with what I am saying. They have been reduced to chain-gang workers, with budget restrictions that force them to save on everything: equipment, surgical instruments, IOLs and time.

In Italy, Diagnosis-Related Group (DRG) reimbursement for cataract surgery is 1,000€ and has undergone continuous reductions over the years. Due to the high volume of cataract operations, the cuts made on them “earn” a considerable amount of money for the NHS.

With this sort of budget, new generations of IOLs (toric, aspheric, multifocal) are unaffordable.

Other NHS systems, such as in the United Kingdom, have similar if not worse problems.

Forms of copayment in which patients contribute to the extra expense when they wish to have something better than the standard product are refused by most European governments as discriminatory. This type of system in which patients can contribute to receive more expensive lenses has been introduced in Bavaria, Germany, and some East European countries (in some cases with a fairly unacceptable lack of control), and it is under evaluation in Spain.

However, unlike in the United States, where the co-payment contributes not only to the higher cost of a better lens but also to the extra services provided by the physician, Europe in general refuses the idea of incentives given to single doctors within the NHS. The most we can obtain, and the most we dare to ask, is co-payment for the product, as if recognizing the additional time, skills and knowledge required by more advanced procedures is somehow unethical.

Multifocal IOLs require more

All of us know that implanting a multifocal IOL is not quite the same as implanting a standard monofocal lens. Multifocal IOLs require a different and more personalized approach. You have to spend more time with your patient preoperatively, in between the two consecutive procedures and in the follow-up. You need more sophisticated equipment for preoperative and postoperative examinations. You need a selection of multifocal IOLs in order to choose the best type or combination for each patient. You have, as a consequence of all this, increased costs.

Accurate patient selection is crucial with this type of lens and should be made on the basis of the patients’ demands and daily habits but, even more, on the basis of objective parameters such as pupil diameter in different light conditions, eye dominance and biometry.

If you deal with a 70- to 75-year-old cataract patient, who is likely to have a narrow pupil with little motility, you have few problems. However, most of the candidates for multifocal IOLs are clear lens exchange patients around the age of 50 years, with a larger and still mobile pupil. In these patients, a multifocal lens, particularly of the refractive type, can cause night vision problems. You therefore need accurate pupillometry.

I generally prefer to implant a diffractive lens first, and always in the nondominant eye, which requires the further step of establishing eye dominance in each patient.

Diffractive lenses are less pupil-dependent. In the week that follows first-eye surgery, I examine refraction and assess adaptation to the lens and the subjective perception of halos. If the patient has no complaints, I implant a refractive lens in the other eye; otherwise, I go for a second diffractive. A patient who is sensitive to halos with this lens in the nondominant eye is unlikely to cope with a refractive IOL in the dominant one.

Accurate biometry is another key point, and I perform it both manually and automated (with the Carl Zeiss Meditec IOLMaster) in each patient, to be more certain of the results. You should have a result within 0.5 D to be on the safe side. Astigmatic eyes are also better avoided, unless a second procedure with laser or limbal relaxing incisions is planned in agreement with the patient.

For the increasing number of clear cornea patients, in particular for those at risk of glaucoma, preoperative OCT with the Visante (Carl Zeiss Meditec) helps the surgeon to measure the anterior chamber depth, lens vaulting and angle size.

Postoperative support must be given to the patient in the process of adapting to the new way of seeing after implantation. We use Eyevispod software, which simulates vision problems and helps the patient in assessing, by comparison, the progressive improvements that occur with adaptation over time.

Hoping for a better future

Needless to say, such a time-consuming, high-quality, personalized approach is unthinkable in the chain-gang, low-budget, poorly equipped cataract surgery factories provided by our health authorities. Those who use multifocal IOLs on these premises do so without the appropriate training and with the wrong criteria, treating it just like a standard monofocal lens. It should be no wonder if their results are poor. It should be no wonder if they contribute to creating a bad image for these lenses.

With the European federation of the national societies of ophthalmology, we are currently working on a document in which the common needs for better quality cataract surgery are clearly expressed, and the request of a 50% increase in the DRG is made to the health authorities of each country.

We are hoping in this way to make a small contribution to a better future for both patients and surgeons.

For more information:

Matteo Piovella, MD, can be reached at Centro Microchirurgia Ambulatoriale, Via Donizetti 24, 20052 Monza, Italy; +39-039-389498; fax: +39-039-230-0964; e-mail: piovella@piovella.com.