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AAO task force releases statement on adverse events for premium IOLs
An American Academy of Ophthalmology task force released a consensus statement on new definitions of adverse events for premium IOLs, including toric, accommodating, multifocal and phakic IOLs.
The task force expanded the “historical control” publication of adverse events to accommodate the development of new premium IOLs, which may present additional adverse events compared with monofocal IOLs, according to the statement.
The task force noted the FDA first published outcomes in 1983 based on publicly available data from IOL premarket approval studies. These were used for the assessment of the safety and effectiveness of newly developed IOLs and were referred to as the “Food and Drug Administration Grid” and “Safety and Performance Endpoints.”
“Premium IOLs may present additional adverse events to those already established for monofocal IOLs. Further, most of the AEs in the ‘Grid’ do not have standard definitions, and the definitions used could have changed over time with advances in our understanding of ocular pathology,” the task force authors wrote.
Please see the full report for the new definitions of postoperative adverse events for premium IOLs.
Disclosure: Masket reports no relevant financial disclosures. Please see the full report for all other authors’ relevant financial disclosures.
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Masket S, et al. Ophthalmology. 2016;doi:10.1016/j.ophtha.2016.09.031.