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First IC-8 IOL implanted in US pivotal study
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In a pivotal study, the first U.S. patient has been implanted with the IC-8 small aperture IOL, according to an AcuFocus press release.
The clear monofocal lens, which has an embedded mini-ring or pinhole in the center to increase a patient’s natural range of vision, will be studied in 475 bilateral cataract patients in the prospective, multicenter, parallel-group study.
Each patient will receive a standard monofocal IOL in one eye and, if visual requirements are met, an IC-8 in the second eye.
“Ophthalmologists and optometrists use pinhole or small aperture technology every day in their clinics to test patients for their best potential vision. So the combination of a monofocal IOL with a tiny pinhole to extend depth of focus simply makes sense,“ Satish Modi, MD, of Seeta Eye Centers in New York, told Healio.com/OSN. “Outside the United States this lens has been used across Europe and Asia to treat a broad range of patients. With the growing body of evidence in the peer review literature about the IC-8 IOL, I look forward to seeing how this lens performs in my hands and am deeply honored to be the first surgeon to implant the lens in the United States as part of the IDE clinical study.”
Editor's note: This article has been updated to include a quote from Satish Modi, MD.