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Phakic IOLs will bring ‘wow’ factor back to refractive surgical practices
Taking a patient from –18 D to plano is “a life-changing event,” surgeon says.
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Phakic IOL in the eye. Enclavation fixation. Images: Donnenfeld ED |
NEW YORK — Phakic IOLs will have a significant impact on refractive surgical practices in the near future, said Eric D. Donnenfeld, MD, here at the Ocular Surgery News Symposium: Cataract Glaucoma & Refractive Surgery.
“LASIK is the dominant, 800-pound gorilla right now,” he told meeting attendees. “But I certainly am beginning to feel that phakic IOLs … are going to have a very significant impact on all our practices.” The Artisan/Verisyse phakic IOL from Ophtec/AMO received U.S. regulatory approval immediately before the OSN New York meeting, Dr. Donnenfeld noted.
Phakic IOLs, he said, provide “high patient and surgeon satisfaction.” In study of 412 patients implanted with phakic IOLs, about 90% said they would recommend the surgery, and an equal number were satisfied with the outcomes at 1 year postoperatively.
In addition, for the 228 eyes in the study at the 3-year follow-up mark, 49% had gained at least one Snellen line. Only 6% lost a line or more at the 3-year follow-up, and some of those patients went on to develop cataracts. “I don’t think I’ve ever seen numbers like those before with a refractive procedure,” he said.
Phakic IOLs
Dr. Donnenfeld spoke about ways to integrate phakic IOLs into an ophthalmic practice. It is a safe procedure with long-term follow-up, and Dr. Donnenfeld noted the lenses have been used in Europe for more than a decade. The recent Food and Drug Administration clinical trials included 1,179 patients; only three developed cataract, Dr. Donnenfeld said. There was a small incidence of retinal detachment in the trial participants, and Dr. Donnenfeld said he believes these “were probably normal numbers” that would have occurred with or without the phakic IOL implantation because of the high levels of preoperative myopia.
“Again, these are people who are very high myopes, with a mean of –12.3 D. A lot of these people would have gone on to develop cataract regardless,” he said.
The PMMA optics of the Artisan phakic IOL “are better than corneal ablative procedures,” he said, and contrast sensitivity is unchanged or improved from preop levels, which is not always the case after a laser procedure for high myopia.
Healing occurs within the first few days after surgery with an IOL; 3 years postoperatively, patients are “incredibly stable,” said Dr. Donnenfeld. In his trial, patients showed a loss of –0.019 D between 6 months and 1 year postoperatively and an average of –0.062 D from year 2 to year 3 postoperatively.
“There’s no wound healing, there’s no corneal changes. This is not a biological system, this is PMMA, and it’s not going to change over time,” Dr. Donnenfeld said.
The implant procedure and enclavation are easy, he said. “While there are certainly considerable differences of opinion, I suggest doing a preop laser iridotomy,” he said. “It’s elegant, it’s simple, and we do it right before the procedure rather than doing a surgical iridotomy.” Further, Dr. Donnenfeld noted that he prefers to use peribulbar anesthesia, although he acknowledges topical anesthesia would be “very reasonable” to use as well.
Dr. Donnenfeld described the enclavation procedure as placing the iris in the split haptic — “the snowplow maneuver,” he called it. The technique is similar to how snow “pops up” above a snowplow. “We push the iris, so the iris gets forced up into the split haptic and is caught in that area,” he said. “We just grab the iris, the iris pops up and goes right into the enclavation site, and we can repeat as necessary. This is not a difficult procedure.”
Additionally, there is an “extraordinary ‘wow’ factor when you take a –18 D patient and bring them to plano,” he said. “It’s a life-changing event.”
The enclavation process | ||
Create small fold of iris tissue and pull into haptic. | Move needle down and create a larger fold of iris tissue. | |
Pull fold of iris and needle through haptic aperture. | ||
Future of refractive surgery
Dr. Donnenfeld said he believes the future of refractive surgery is IOLs, and by combining phakic IOLs with LASIK, physicians can “achieve extraordinary visual results.” Phakic IOLs give surgeons who may not be comfortable incorporating typical refractive procedures into their practices a way to expand their potential patient base with the ability to treat people in their 30s, 40s and 50s, he said.
“If you want to fine-tune, it’s very simple to do,” he told attendees. “A bioptic adding an astigmatic keratotomy, a LASIK or PRK, or conductive keratoplasty to your phakic IOL” can give patients the visual results they desire while correcting wavefront abnormalities simultaneously.
In addition to the Artisan/Verisyse, the Visian ICL (STAAR Surgical), another phakic IOL, has been filed for marketing approval in the United States and is commercially available in Europe. Other phakic IOLs have been approved for use in Europe as far back as 1989.
For Your Information:
- Eric D. Donnenfeld, MD, is a cornea specialist in private practice at Ophthalmic Consultants of Long Island and co-chairman of Cornea and External Disease at Manhattan Eye, Ear and Throat Hospital. He can be reached at Ryan Medical Arts Building, 2000 North Village Ave., Rockville Centre, NY 11570; 516-766-2519; fax: 516-766-3714; e-mail: eddoph@aol.com. Dr. Donnenfeld is a consultant for Advanced Medical Optics.
- Michelle Dalton Liberatore is Managing Editor of the OSN SuperSite. She writes daily updates on developments in all aspects of ophthalmology.