AcuFocus receives FDA approval for IC-8 clinical study

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 (Read more...)

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