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Should You Add Phakic IOLs?
This removable alternative to LASIK is a logical addition for surgical facilities already performing cataract surgery.
Jason Stahl
Publish Date: October 10, 2007   |  Tags:   Ophthalmology

Slowly but steadily, we're implanting more and more phakic IOLs at my surgical center. While the procedure is far from high volume (we do between five and 10 cases per month) and the price can be prohibitive to patients ($3,500 to $4,500 per eye for this elective procedure), the phakic IOLs can outperform LASIK in patients with moderate to high myopia. Plus, if you're performing cataract surgery, your center is already equipped to add phakic IOLs. So why not offer patients lenses with the power of refractive surgery?

Understand the market
Two phakic IOLs currently have FDA approval in the United States: AMO's Verisyse and the Staar Visian ICL. A third lens, designed by Alcon and now in trial, is referred to as the Alcon AcrySof Phakic IOL. Both approved lenses can provide better vision for higher myopes than corneal laser surgery. Many moderate and high myopes aren't ideal candidates for laser surgery because of their degree of myopia, inadequate corneal thickness, flat corneal curvature or corneal surface abnormalities. Traditionally, phakic IOLs were only performed on high myopes (-10 diopters to -20 diopters), but I have become comfortable with the procedure and will now consider phakic IOLs for even low levels of myopia (-3 diopters to -5 diopters) if the patients aren't great candidates for corneal laser surgery (LASIK or PRK).

The procedure is ideally suited for patients in their early 20s to late 40s. Patients in their 50s and older, especially those with high myopia, develop cataracts at an earlier age and are typically better candidates for a refractive lens exchange and implantation of a presbyopia-correcting IOL that provides both distance and near vision.

The lack of Medicare or private payer influences on this elective procedure means you can name your own price and pass 100 percent of the cost to the patient. But as with any price-setting protocol, you should focus on the basic laws of supply and demand. The target patient population for this procedure has disposable income, but won't spend it at your facility if prices are too high.

Patients are responsible for the cost of the lens, the facility's fee and the physician's fee. The Verisyse lens lists for $695 and the Visian ICL for $800. Your facility fee might range from $900 to $1,200. Physician fees typically run between $1,500 and $2,500. Those figures run the total patient bill to $3,500 to $4,500 per eye. That's a big number, and one you'll need to set carefully (see "Setting Your Fees" on the next page).

Setting Your Fees

Phakic IOL implantation is an elective procedure, meaning you can set your facility fee to cover your costs, turn a profit and pass 100 percent of the true IOL cost on to the patient. You can determine your price based on patient expectations and your competitive marketplace. Asking your patients to pay an exorbitant facility fee and implant charge will price you and your surgeons out of the refractive market.

Research your local market for a realistic idea of the procedure's price point. Refractive IOL patients will pay between $3,500 and $4,500 per eye, and that payment needs to satisfy your facility's fees, anesthesia services, the fees of the operating surgeon ($1,500 to $2,500) and the cost of the lens ($900 and $1,100, including shipping). We've seen facility fees range from $1,000 to $1,400. Charge more, and surgeons will look elsewhere for a facility that takes a smaller slice out of the $4,500 pie. Charge less, and you run the risk of failing to cover the procedure's expenses and a fair profit. - John Blanck

Mr. Blanck ([email protected]) serves as administrator of the Overland Park Eye Surgery Center in Overland Park, Kan., the facility where Jason Stahl, MD, performs his phakic IOL procedures.

Clinical considerations
Because both Verisyse and Visian ICL implants will block the natural flow of aqueous fluid through the pupil, a YAG laser peripheral iridotomy is performed before implanting either lens. Implanting the lenses without first performing iridotomies results in a build-up of the aqueous fluid in the anterior chamber, a spike in pressure and, ultimately, the risk of acute glaucoma.

While the purpose of the iridotomies is the same for both lenses, the timing of the laser procedure is different for each. Since the pupil is constricted with pilocarpine drops for both the YAG laser PI and Verisyse procedures, you can perform the iridotomy on the day of surgery when implanting the Verisyse - so factor additional pre-op time into the scheduling of your patients.

Surgeons must perform iridotomies one week to two weeks before they implant the Visian ICL because of the pupil dilation required for placement of the lens. If you don't already have a YAG laser, the surgeon will need to perform a surgical peripheral iridectomy at the time of phakic implantation, but most surgeons prefer YAG laser PIs. The laser equipment can be an expensive addition to your facility, ranging from $10,000 for a used model to $30,000 for new, but if your facility is currently performing cataract surgery you most likely already have the equipment for performing YAG laser capsulotomies.

In the OR, the skill sets required for the surgeon and OR staff to implant phakic IOLs are very similar to those for cataract surgery. Keep in mind that the phacoemulsification stage is eliminated. I can insert the Visian ICL in about 10 minutes and the Verisyse in 10 minutes to 15 minutes. The additional time for the Verisyse is due to the suturing of the larger incision that is required for implanting the lens.

Those times match those of my cataract cases. When considering scheduling for phakic procedures, you can count on the phakic cases fitting perfectly into your cataract blocks. If your facility is set up for 10 cataract cases, your surgeon can easily perform 10 phakic procedures.

One scheduling caveat when implanting the Visian ICL: Patients receiving this lens require a check of the intraocular pressure two hours to four hours post-op. The exam ensures the lens was adequately sized and all viscoelastic was removed from the eye. I see the patients in my clinic for the pressure check, but this exam can be done at the surgical center if it's equipped with a slit-lamp and tonometer. Schedule Visian ICL cases in the morning or early afternoon so you can still examine patients post-op without keeping you and your staff at work late.

Pearls for implanting
The methods used to implant the Verisyse and Visian ICL are slightly different. Different techniques and different challenges call for unique instrument requirements. Here are my instrumentation preferences for each lens.

  • Verisyse. Budo forceps (to hold the IOL during enclavation), enclavation needle (used to attach the iris to the IOL), 0.12 forceps, tying forceps, paracentesis knife, crescent knife, 3.0mm keratome, Miochol (intraocular syringe/cannula), Amvisc plus, Balanced Salt Solution with syringe/cannula and 10-0 nylon suture.
  • Visian ICL. ICL cartridge and injector, Vukich ICL manipulator, Duet lens-loading forceps, 0.12 forceps, paracentesis knife, 3.0mm keratome, Ocucoat, Balanced Salt Solution with syringe/cannula, Miochol (intraocular syringe/cannula) and suture set available in reserve.

The Verisyse is placed in front of the eye's natural lens and attached to the iris during implantation. You'll need to outfit your surgeons with specialized forceps used to hold the lens during this maneuver and an enclavation needle to attach the Verisyse to the iris. Because a larger incision is required to insert this non-foldable PMMA lens, surgeons need to suture the incision. I typically close the incision with three 10-0 nylon sutures.

The Verisyse Phakic IOL
Advanced Medical Optics
List Price: $695

  • How are lenses ordered? Order two lenses for each eye (one as backup) and then return the extra after surgery.
  • Is consignment offered or are there inventory requirements? AMO doesn't offer consignment and doesn't require you to maintain a certain inventory level.
  • Is OR staff training available? AMO's field team provides staff training as needed.
  • What instrumentation is required? Regular set up and equipment for a standard cataract surgery, plus instruments specific to the Verisyse: Verisyse IOL manipulator, Verisyse enclavation forceps, Verisyse implantation forceps and Verisyse enclavation needle. Peripheral irdidectomy is a standard part of the Verisyse implantation procedure so surgeons must have access to a YAG laser or be able to perform manual PI.
  • Do surgeons need to be trained and certified before implanting the lens? Yes, surgeons need to complete an online training module. AMO provides on-site didactic and wet lab training.

The Visian ICL
Staar Surgical
List Price: $800

  • How are lenses ordered? E-mail or fax.
  • Is consignment offered or are there inventory requirements? Lenses aren't consigned and there are no inventory requirements. Centers that take advantage of the inventory purchase program receive 10 percent off the list price. All orders receive a backup lens of the same power and length as the primary lens.
  • Is OR staff training available? Yes. Staar performs on-site staff training during the physician certification process. Practice development staff provides additional training as necessary.
  • What instrumentation is required? Implantation is performed using standard cataract instruments, with the addition of an ICL loading forceps and an ICL manipulator.
  • Do surgeons need to be trained and certified before implanting the lens? Yes. Physician certification is part of a two-step training program. Surgeons must first attend a three-day ICL training course. Day one includes four hours of didactic education covering appropriate patient selection, the pre-operative exam, surgical preparation, surgical technique and post-op care. Day two involves observation of live surgery; short- and long-term post-op patients are evaluated on-site and complication management is discussed in detail on the third day. After the training course, surgeons must receive on-site proctoring during their first five cases. Physician certification is achieved by successfully demonstrating proficiency in placement of the Visian ICL, with an ICL applications specialist present.

The Visian ICL is a foldable silicone lens. It's placed into an inserter and injected into the eye through a 2.8mm to 3.0mm incision. Once inserted, the lens unfolds and is maneuvered behind the iris and into the sulcus. Since the pupil is dilated and surgeons are working only in the small anterior chamber space, they must be very cognizant of avoiding any trauma to the eye's natural lens. If the crystalline lens is touched during the procedure, the patient will develop a cataract in that area.

Phakic IOLs are removable. They can be exchanged for power considerations or explanted if needed and the patient will return to their previous myopia. LASIK, of course, is not reversible.

Focusing on the future
Patient satisfaction with the phakic IOLs is excellent. Those who have the potential to achieve 20/20 vision often see at that level or better following surgery. The lenses improve patients' best-corrected vision and are the preeminent option for improving the quality and quantity of vision in highly nearsighted patients.

The popularity of phakic IOLs will slowly increase as the public becomes more aware of this myopia-correcting option and surgeons continue to familiarize themselves with the procedure. I believe that as lens technology improves over the next five years, the utility of the lenses will rival LASIK for even the correction of moderate myopia.