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Surgeon recommends careful monitoring of angle-supported phakic IOL patients
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STOCKHOLM, Sweden — Although angle-supported phakic IOLs continue to be available in many countries, one surgeon advises against using such lenses until further studies provide more reliable information on their safety.
 Joseph Colin |
"Endothelial cell loss is a major problem with these lenses, as demonstrated by several cases of explantation with both the GBR Vivarte/NewLife (IOLTech/Carl Zeiss Meditec) and the Icare (Corneal) models," said Joseph Colin, MD, at the European Society of Cataract and Refractive Surgeons meeting. "A sudden and irreversible acceleration of endothelial cell loss seems to occur, for reasons that are still unknown, 2 to 3 years after implantation."
Manufacturers already ordered the withdrawal of these lenses from the market in France in accordance with the French Sanitary Safety of Health Products Agency at the beginning of this year. French ophthalmologists were also required to monitor previously implanted patients, reporting all cases of endothelial cell loss to the authorities and explanting the IOLs in all high-risk cases.
"Evaluation of the endothelial cell count every 6 months after implantation of all anterior chamber [phakic] IOLs is mandatory," Dr. Colin said. "If a decrease of more than 30% of corneal endothelial cells or a rate of less that 1,500 cells/mm2 is observed, explantation is recommended."
"Removing a phakic IOL is not difficult. Since they are foldable, it is easy to cut the soft optic with scissors and then remove the two pieces. So don't wait until the cell count is too low," he said.
As an alternative procedure after removal, patients can undergo a refractive lensectomy because implanting another phakic IOL in eyes with a low endothelial cell count could lead to corneal transplantation in many cases, Dr. Colin said.
Most cases of explantation were correlated with older methods of preoperative sizing, such as measuring the white-to-white distance, he noted.
"If you look at the retrospective analysis of two groups of eyes implanted with the Corneal Icare phakic IOL, you can see the cell loss after surgery was 10 times higher in the group of patients who were measured preoperatively with the subjective white-to-white system as compared with those evaluated with modern imaging technologies. None of the Icare [lenses] that were subsequently explanted belonged to this latter group," he said.