The recent approval of the Acrysof Restor IOL (Alcon Laboratories, Inc., Fort Worth, TX) gives patients the potential for freedom from their spectacles after cataract or refractive lens exchange surgery. Proper patient selection combined with careful preoperative evaluation and counseling are paramount both to successful results and to patients' satisfaction.
WHO IS A CANDIDATE?
As with any refractive cataract procedure, surgeons may subjectively rule out certain patients for the Restor IOL. I recommend avoiding individuals who are overly critical and have unrealistic expectations, such as the patient who states a need for perfect vision at all distances, in all lighting situations. Obviously, those who prefer wearing glasses for cosmetic or safety reasons are also poor candidates. Finally, a small percentage of subjects in the FDA trial of the Restor described halos as moderate to severe. Ophthalmologists should therefore caution individuals who must drive at night about the remote possibility of significant halos. Such patients are probably not the best initial candidates for this IOL.
Purely refractive patients should be aware of alternative treatments. The mild-to-moderate myope under 50 years of age may be better served by laser refractive surgery than presbyopic lens exchange based on his risk for retinal detachment. Even presbyopic myopes may opt for LASIK with some degree of monovision adjustment provided they have no cataract. Patients with ocular pathology that will limit their postoperative visual potential also are not good candidates for presbyopic correction.
If the patient has more than 1.00D of corneal astigmatism, the surgeon must be able to reduce the astigmatism to less than 1.00D or risk an unacceptable result. I strongly recommend using corneal topography to confirm the steep axis of the cylinder, the amount of cylinder, and the regularity of the astigmatism.
Patients who have been satisfied by monovision with contact lenses but no longer desire to wear contacts may be better suited to refractive lens exchange with monofocal IOLs, a modality that will mimic their current success. I hesitate to alter a presbyopic solution that is already working well.
Patients with small pupils need not be excluded, because the design of the Restor IOL allows for functional distance and near vision, even in the presence of very small pupils.
One must also reflect on the lack of coverage for presbyopic correction by Medicare and private insurance carriers. The Centers for Medicare and Medicaid Services, however, recently ruled in favor of allowing Medicare patients to pay out of pocket for the not covered service of presbyopic reduction, which includes charges for the IOL and surgeon's fees. It is important to consult a reimbursement specialist in order to fully understand which patients may be offered this new lens technology and what documentation is necessary.
Managing Patients' Expectations
Surgeons must provide each patient with as much information as possible regarding what the Restor IOL can and cannot do. They should discuss the surgical procedure, its alternatives and risks, how the IOL works, and its strengths and limitations.
Patients who have adjusted to presbyopia by holding reading material away from them need to understand that their best reading distance may be closer postoperatively. They must also recognize that, although their vision should be good at all distances, their distance and near vision will likely be superior to their intermediate vision. Patients should be counseled to expect some halos, which will likely be mild and decrease in time. Additionally, the ophthalmologist should address the possibility for an enhancement with a laser, IOL exchange, or a piggyback lens if the postoperative refractive result is not acceptable.
Accurate preoperative testing is essential to success. I suggest using optical biometry (eg, the IOLMaster [Carl Zeiss Meditec Inc., Dublin, CA]) to measure axial length most accurately. If a dense cataract prevents the use of optical biometry, an immersion A-scan is preferable to applanation ultrasound. Accurate keratometry is also important. I recommend confirming manual K readings with those from the IOLMaster or another secondary source.
To determine the correct IOL power, I recommend employing a newer-generation formula such as the Holladay II, SRK/T, or Haigis. All surgeons should evaluate their first 30 patients in order to personalize these formulae for their own “surgeon factor.” The recommended target postoperative refraction for the Restor is plano to +0.25D.
The Acrysof Restor IOL is a welcome addition to the options for patients undergoing cataract or refractive lens surgery. Proper screening, counseling, and preoperative testing will help to ensure successful outcomes and happy patients.
Robert J. Cionni, MD, is Medical Director of the Cincinnati Eye Institute in Ohio. He was an investigator in the FDA trial of the Restor IOL and is a consultant to Alcon Laboratories, Inc. Dr. Cionni may be reached at (513) 984-5133; email@example.com.