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New-generation, pre-loaded MICS lens produces good FDA trial results
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MILAN — The new-generation Hoya 251 IOL for microincision, already available in Europe and Asia, has emerged from its U.S. Food and Drug Administration trial with good outcomes, according to a surgeon here.
“The previous three-piece model available for a decade has transitioned to a one-piece. The lens is preloaded into a dedicated inserter, which can be used to gently guide the lens to [unfold]. The PMMA non-stick haptic tips help the lens to easily self-position in the bag. The aspheric balanced curve optic design provides excellent visual quality and forgives decentration up to 0.5 mm,” Kenneth R. Kenyon, MD, said at the annual joint meeting of Ocular Surgery News and the Italian Society of Ophthalmology.
Kenneth R. Kenyon
The multicenter FDA trial included 125 eyes and five sites. Six-month follow-up has been completed by 97% of the participants.
“The lens showed excellent visual outcomes, with 95% of the eyes achieving 20/25 or better. Refractive predictability was very high, in spite of the multiple centers with multiple surgeons involved, with 80% of the eyes within ± 0.5 D of target,” Kenyon said.
Despite the short-term nature of the trial, the fact that posterior capsular opacification graded 0 or traces-only was noted in 98% of eyes is encouraging, according to Kenyon. No cases of endophthalmistis were found.
“The inserter reduces not only the risk of IOL damage, but also that of toxic anterior segment syndrome and endophthalmitis,” Kenyon said.
Disclosures: Kenyon is a consultant to Hoya Surgical Optics.