AcuFocus has completed enrollment in a pivotal investigational device exemption study of the IC-8, its small aperture IOL for patients with cataracts, according to a press release.
The IC-8, a clear monofocal lens with an embedded mini-ring or pinhole in the center, is designed to increase the natural range of vision by extending the focus of light rays that enter the eye, the release said.
The 12-month, prospective, multicenter, nonrandomized case control clinical trial will compare the IC-8 with traditional monofocal IOLs.
“Running a successful clinical trial depends on all participants — from the sponsor to the investigational sites — taking their role seriously and executing with high standards and focus,” Magda Michna, PhD, AcuFocus chief global clinical and regulatory affairs officer, said in the release. “I couldn’t be more pleased with the team and their efforts to meet the aggressive enrollment challenge we set forth.”