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AcrySof phakic IOL shows good safety profile in trials, surgeon says
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LONDON — Data from European clinical studies investigating an angle-supported phakic IOL for correcting high myopia show a good safety profile for the lens with minimal endothelial cell loss, according to an investigator speaking here.
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Thomas Kohnen, MD, presented the safety outcomes for 323 patients implanted with the Alcon AcrySof phakic IOL at the European Society of Cataract and Refractive Surgeons meeting. The study was part of phase 2 and phase 3 European clinical trials.
"We need to look at the safety issue. We need to be sure we don't cause problems for our patients," he said.
According to Dr. Kohnen, patients maintained best corrected visual acuity through follow-up at 6 months, 1 year and 2 years. Only one out of 112 patients lost two or more lines of BCVA at the 2-year follow-up, he said. He noted that patients rarely lost more than one line.
Patients had a surgical loss of 3.69% of central corneal cell density and a loss of 4.05% of peripheral corneal cell density, which manifested between 3 and 6 months postop.
Chronic corneal cell loss from 6 months to 1 year follow-up averaged 0.19% in the central area and 1.09% in the periphery, Dr. Kohnen said. At 18 months follow-up, chronic corneal cell loss averaged 0.91% in the central cornea and 0.94% in the periphery.
"The endothelial cell density data indicate adequate clearance between the IOL and the cornea," Dr. Kohnen said. He noted that the outcomes support continued investigation.