Incorporating the Verisyse Phakic IOL into Practice
Patient satisfaction with this IOL is high 1 year after FDA approval.
BY RACHEL RENSHAW, EXECUTIVE EDITOR

The Verisyse Phakic IOL (Advanced Medical Optics [AMO], Santa Ana, Calif.) was approved by the FDA on Sept. 10, 2004 after several years of clinical trials that showed the safety and efficacy of the implant for patients with moderate to severe myopia. The commercial availability of the phakic IOL opened new doors for patients who were previously not considered candidates for refractive surgery, and offered a viable option for patients who were hesitant to undergo a laser ablation procedure.

One year later, Ophthalmology Management talks with two of the original clinical investigators for the Verisyse to find out how this IOL has impacted their practices since FDA approval. This article will address patient demand, acceptance and satisfaction, as well as how clinicians can expect phakic IOLs to fit within their practice.

Gregory J. Pamel, M.D., medical director of Pamel Vision and Laser Group and an attending surgeon at Manhattan Eye, Ear and Throat Hospital in New York, and one of the clinical investigators for the Verisyse, says that patients' reactions to the IOL have been "overwhelmingly positive."

"During the clinical trials, the FDA mandated that we wait 3 months before implanting the second eye — everyone wanted to have their second eye done right away," he says. "Patients who were essentially functionally blind without glasses or contacts can now function with the lens, so the results are quite dramatic."

Eric D. Donnenfeld, M.D., medical director of TLC Laser Center in New York and a partner with Ophthalmic Consultants of Long Island and Connecticut, was also an investigator for Verisyse and implanted approximately 40 of these IOLs during the course of the FDA clinical trials. Dr. Donnenfeld says that his patients who have severe myopia and who are not candidates for LASIK are excited about the availability of the Verisyse IOL.

"Early on [after the initial FDA approval], there was a lot of demand from patients who were highly myopic and were actually waiting for this lens to become available," says Dr. Donnenfeld.

Dr. Pamel, who implanted approximately 50 Verisyse IOLs in the trials and who has implanted 60 more in the past year, reports that his results with this phakic IOL have been successful.

"The calculation for the implant powers are accurate so we're close to the initial refractive goal. As a result, patient expectations have been exceeded in terms of quality of vision," says Dr. Pamel. "Over 50% of the time, patients have gained one or more lines of vision than BCVA prior to surgery."

Dr. Donnenfeld agrees that the results with the Verisyse have been impressive.

"The patients who are candidates for this lens are the most visually handicapped in our practice, so they are also the most delighted with the results," he says. "We're taking these patients from -12 D, -18 D, and -20 D and giving them good UCVA, so they are thrilled."

Side Effects and Complications

While neither Dr. Pamel nor Dr. Donnenfeld has had to explant a Verisyse IOL because of patient complaints after surgery, there are some side effects, such as glare and halos, that some patients have experienced.

Says Dr. Pamel, "with time, the symptoms [of nighttime glare and halos] have subsided. I think that when the second eye is implanted, the glare subsides significantly."

Dr. Donnenfeld has also seen relatively few complications with the Verisyse.

"I've experienced no infectious complications, no cataracts and no endothelial cell problems," says Dr. Donnenfeld. "The kind of complications I've seen are those that are basic refractive surgery concerns. There may be some residual astigmatism after surgery, and there can be residual spherical problems so that occasionally patients are slightly under- or overcorrected, but for the most part, the preoperative calculations are fairly precise."

Dr. Donnenfeld says that when secondary procedures are required, he will either perform LASIK over Verisyse to correct residual amounts of refractive error or keratotomy to correct residual amounts of astigmatism.

In regard to the potential side effect of cataract development, both clinicians agree that it is important to inform patients preoperatively of the risk.

"I counsel every patient that because they are near-sighted, they are at higher risk for developing cataracts earlier. However, in the entire FDA clinical trial, there were only three or four cases of cataracts in over 1,100 procedures that were specifically attributable to the Verisyse," says Dr. Pamel.

Incorporating Verisyse into Practice

When patients come into Dr. Pamel's office seeking refractive correction, he says that the availability of the Verisyse extends the field of options.

"First, there are patients who come in for LASIK who are skeptical about the results because it's a permanent procedure that removes tissue from the eye," Dr. Pamel says. "Now there's an alternative procedure that I can offer them in the Verisyse that is potentially reversible."

"Second, there are those patients who come in wanting LASIK and are not candidates. Many of them have been waiting for this technology, have done their research and are ready to have the procedure done," he continues.

Dr. Donnenfeld says that while a steady number of patients come in for the procedure, Verisyse implantation represents a relatively small portion of his refractive practice.

"As far as an absolute number [of Verisyse IOLs implanted], we do about five to six patients per month," he says. "These are patients who are outliers for LASIK — there aren't many patients who need this surgery. However, the ones who do need it are the most thrilled with their results. It makes an enormous difference in patients' lives."

Dr. Donnenfeld says when patients are candidates for both procedures, he will still choose LASIK, but that it depends on the parameters he sets for patient evaluation.

"In general, patients who are -10 D and above are candidates for phakic IOLs and patients who are lower than
-10 D are candidates for LASIK," he says. "However, there is some overlap, and I've put phakic IOLs in patients who are as low as -8 D and performed LASIK on patients who are as high as -12 D, depending on pupil size, corneal pachymetry and keratometry."

In regard to pearls for enclavation, or the process of securing the haptics into a knuckle of the iris, Dr. Donnenfeld offers the following advice to surgeons implanting the Verisyse.

"Healon GV (AMO) has a tremendous advantage over conventional viscoelastic because it stays in the eye and maintains space better, making enclavation easier," says Dr. Donnenfeld.

To perform enclavation, Dr. Donnenfeld recommends that surgeons always err on the side of taking more iris into the haptic than less, because too little iris could translate into a displaced or unsecure IOL.

New Developments

Currently, Verisyse remains the only FDA-approved phakic IOL and the technology continues to evolve. Surgical pearls and new tools for implantation, such as new enclavation forceps being worked on by Dr. Donnenfeld and his colleagues, continue to be developed. Additionally, AMO will soon begin clinical trials on the foldable version of the IOL, the Veriflex.