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In European experience, phakic IOLs a story of hope and disappointment
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PARIS — With 20 years experience implanting phakic IOLs in Europe, phakic IOLs have "a long history of short-term success and long-term failure," French Society of Ophthalmology president Joseph Colin, MD, said here. And while early results with a new phakic IOL are encouraging, a great amount of caution is necessary.
During a joint symposium with the French Society of Ophthalmology and the American Academy of Ophthalmology, Dr. Colin reviewed the up-and-down history of the European experience with phakic IOLs and the recent problems with endothelial cell loss encountered with angle-supported phakic lenses.
As was well-publicized in the media, angle-supported phakic IOL manufacturers IOLTech/Carl Zeiss Meditec and Corneal, in cooperation with the French Agency for the Sanitary Safety of Health Products (AFSSAPS), withdrew the Vivarte and NewLife phakic IOLs in January 2007 and the Icare lens in March 2007, Dr. Colin said.
"A study retrospectively carried out at several centers in France confirmed the high incidence of the complication 2 to 3 years after implantation for the NewLife phakic IOLs," Dr. Colin said. "Among 2,324 implants, 27 were removed due to significant endothelial cell loss."
A similar although smaller risk was found with the GBR/Vivarte phakic IOL, with 15 explantations out of 4,033 cases, he said.
After the retrospective reviews, AFSSAPS recommended all anterior chamber phakic IOLs undergo a mandatory evaluation of the endothelial cell count every 6 months after implantation. Currently, if a decrease of more than 30% of endothelial cells or density of less than 1,500 cells/mm² is observed, explantation is recommended, he said.
Despite these problems, phakic IOLs are still growing in popularity, and there is good reason to continue to search for a workable solution with these lenses. Dr. Colin said they are a good choice in cases in which laser refractive surgery is not indicated, such as thin corneas, and phakic IOLs preserve accommodation and are easily removed in most cases.
Researchers have also learned a number of criteria to avoid complications in angle-supported lenses, he said. Among those are an anterior chamber depth of more than 3 mm, a corneal diameter greater than 11 mm and an IOL power of less than 20 D.
Dr. Colin said he has been encouraged by results of a multicenter European phase 3 study of the Alcon AcrySof phakic IOL. At the 2-year follow-up, the researchers found minimal effects on endothelial cell loss. All eyes maintained best corrected visual acuity, there was no reported chronic inflammation or raised IOP, and there were few adverse events. The lens also showed a high rate of predictability and stable refraction over the 2-year time period, he said.
Despite the positive results, given the recent history of angle-supported phakic IOLs, Dr. Colin urged caution until longer-term results are known.
While researchers have found that many complications resulted from improper IOL sizing, which is now limited by new imaging technology, Dr. Colin said, "Current models must not be used until the results of retrospective studies provide more reliable information on the safety of these implants."