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Inside the New IOL That Reverses Presbyopia
Some are calling the Crystalens a dramatic breakthrough in refractive surgery. Here's one facility's early experience with the artificial lens implant.
Jim Van Dyke
Publish Date: October 10, 2007   |  Tags:   Ophthalmology

It's called the Crystalens. And as far as my surgeon and I are concerned, this new accommodative intraocular lens from Eyeonics is the most dramatic breakthrough in refractive surgery in the last 20 years. With these lenses, FDA-approved in August for reversing presbyopia, you can give your patients their near vision back - all while correcting or preventing cataracts. Here's how we're doing it successfully, and what you need to know to add the accommodative lens procedure to your facility.

Accommodative lens basics
The only accommodative IOL available on the U.S. market, the Crystalens is a single-focus silicone lens with hinges on the haptics that provides permanent vision correction. We tell our patients that the accommodation is natural because of the hinges, which let the lens move backward and forward in conjunction with the eye muscles - which in turn lets the eye focus on everything near, far and in between.

The nearest you can get to this kind of treatment for presbyopia with a traditional IOL is a multifocal lens, which has rings on it similar to a bifocal. But it won't move within the eye, as the natural lens would, and as the Crystalens does.

Since April, my surgeon, Britt A. Buckley, MD, has done the accommodative IOL procedure on 120 patients.

Surgeon training
Eyeonics requires that surgeons undergo a certification process before they can implant the lens. They receive training, then implant the lens in 20 eyes (10 patients) under the direct supervision of a member of the company's medical staff. To earn the certification, a surgeon's results must be within 10 points of post-op refractive targeted outcomes so that patients will have similar to or better outcomes than documented in the lens's FDA trials.

Eyeonics only lets you schedule four patients the first time you do the procedure; we did the other six about a week later. As soon as you've done eye No. 20, the company certifies you.

The company is very particular; I've heard of more than one surgeon refused certification - so you must be serious about adding the procedure. I also recommend that you have an ophthalmologist who is not only a cataract surgeon but also a refractive surgeon, because LASIK is required in about 5 percent of patients for fine-tuning. With patients who have more than 2.5-diopters astigmatism, the percentage of patients needing LASIK is much higher.

Patient selection is a bit more restrictive for the first 20 eyes; you won't operate on any with astigmatism. But once you're certified, you can perform the procedure on pretty much any presbyope.

Unique Design of the Crystalens

' The only accommodative IOL on the U.S. market

' Designed to mimic the eye's natural ability to focus on distant, middle and near objects and restore a full range of functional vision without total dependence on glasses or contact lenses

' A single-focus silicone lens with hinges on the haptics; the hinges let the lens move to seamlessly focus on objects near, far and all distances in between

' Used in conjunction with standard cataract extraction methods

' FDA two-year clinical study results: 92 percent of the people enrolled in the study (implanted bilaterally) could see 20/25 or better at distance, 96 percent could see 20/20 at arm's length and 73 percent could see 20/25 at near without glasses or contact lenses

Attracting patients
To line up our initial 10 patients, we offered a 50 percent discount on the cost of the procedure (which I'll talk about later) and filled the slots with potential LASIK patients. They really jumped at the chance.

We started by simply identifying Dr. Buckley's presbyopic patients and sending them a letter telling them about the procedure. We've done this three times in six months, and we're getting ready to do it again. We've also done television ads.

I talk to about 40 people a month about the procedure in information sessions and one on-one-consultations; about 60 percent go through with the procedure.

Complications range from minor, usually temporary side effects, to sight-threatening complications (such as infection and retinal detachment). According to current data, 98 percent of patients have no complications after surgery.

The majority of our patients are in the 50-to-65 age group, so if they have cataracts or developing cataracts, all the better: Their vision will be much brighter with the accommodative IOL than it was before. If they don't already have cataracts, removing the crystalline lens is part of the procedure so they won't develop them.

Finding the time
The implantation itself isn't much different than that for any other IOL; it's different in that the lens is shaped slightly differently, but you're looking at essentially the same procedure times as for cataract surgery - about 15 minutes to 20 minutes per eye. We typically give patients midazolam (Versed) and eye-numbing drops, so they're up and about 15 minutes after the procedure. From check-in to discharge, the patient is in the surgery center for about two hours.

Dr. Buckley does the procedures at an ASC one day a week and does about 10 or 12 each day for a total of 40 to 50 per month. He does one eye at a time, two weeks apart.

Regarding reimbursement
This is a pay-out-of-pocket procedure. I find that most patients are middle to upper-middle class and pay cash because they're at a point in their lives when children are out of the house, but they're still working and have discretionary income. They also want to see better, and they're willing to pay for it. A few patients have financed their operations - the companies that finance LASIK procedures will also do it for accommodative IOLs.

We charge $4,000 per eye, but many surgeons are charging $5,000 and I've heard of one charging $7,000 per eye. Calculate your facility overhead plus the cost of the lenses (about $800 apiece) to determine what you need to charge to turn a profit; Eyeonics puts it around $4,500 to $5,000.

Post-op eye push-ups
For the first 10 days post-op, we give the patients cycoplegic drugs to paralyze the ciliary and pupilary muscles so the lens can settle. This means they'll need reading glasses for anything up close and that they're going to be very light-sensitive, so sunglasses are in order. We see patients one-day and 10-days post-op to check that the lens is properly seated in the capsule and that the patient is seeing well at a distance.

Four days later, Dr. Buckley does the procedure on the second eye, and the cycle starts over again. Off the bat, we shoot for 20/30 vision in the non-dominant eye to give better close-up visual acuity. In addition, on the second day 10, we give patients eye exercises to do daily and instruct them to use their reading glasses as little as possible so their eye muscles begin to strengthen. We prescribe eye exercises - dubbed eye push-ups - 10 minutes at a time, once a day, every day. Depending on the patient and his dedication, it usually takes one month to three months for the patient to fully gain his near vision. We schedule another major check-up at three months post-op to check on the lens, the patient's progress with vision and to address whether LASIK will be needed for fine-tuning.

Even if patients haven't fully gained near vision at three months, many are very satisfied because they know it's going to get better. That's why managing patient expectations is so important - we tell them up front that this procedure doesn't result in instantaneous gratification, but that with diligence, they will achieve their goals. If patients go into the procedure knowing that, they're more likely to be satisfied post-op.

We've not seen any problems with the lens, and because it's similar to cataract surgery and profitable, it's been an easy transition and a great addition to Dr. Buckley's caseload.