AcuFocus received approval for an investigational device exemption from the FDA to conduct a clinical study of the IC-8, a small aperture monofocal IOL for patients with cataracts.
The lens has a pinhole in the center and is designed to increase a patient’s range of vision by extending the focus of light rays that enter the eye, according to a company press release.
The prospective, multicenter, parallel-group pivotal study will enroll approximately 475 patients with bilateral cataracts to demonstrate the extended depth of focus achieved with the IC-8 IOL compared with a traditional monofocal IOL. Patients will be followed for 12 months and evaluated for vision improvement at all distances, according to the release.
“Studies performed outside the United States have shown that the IC-8 lens delivers reliable extended depth of focus with high levels of patient satisfaction,” Al Waterhouse, AcuFocus CEO, said in the release. “Achieving IDE approval was the next critical milestone for the company as we seek premarket approval in the United States.”