Perspective

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 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.”

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.”

    Perspective

    AcuFocus is a company that specializes in small aperture technology for extended depth of focus. It has developed an IOL that utilizes this technology called the IC-8. The FDA IDE approval to begin a study is a milestone in the next step to bringing this technology to the U.S. market and to make it available for U.S. surgeons. It is CE marked in Europe, and it is already in use in Australia. It has had a fantastic track record for use in patients who wish to have improved facility of intermediate and near vision, while preserving their distance vision. The U.S. trial, as with all new technology, is an important step in getting approval for use in the United States, and we’re looking forward to getting underway.

    • John A. Vukich, MD
    • Davis Duehr Dean Center for Refractive Surgery
      Madison, Wisconsin

    Disclosures: Vukich reports he is a medical monitor for the U.S. clinical trial and a consultant for AcuFocus.