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European Post-Market Study of AcuFocus IC-8 Small Aperture IOL Published in Journal of Cataract & Refractive Surgery

Irvine, Calif. – August 21, 2017 – AcuFocus, Inc. (www.acufocus.com), the global leader in small-aperture technology, today announced the publication of a European post-market study with its extended depth of focus intraocular lens (IOL), the IC-8® small aperture IOL, in the July issue of the peer-reviewed Journal of Cataract & Refractive Surgery.

The prospective, open label, multi-center clinical study titled “Prospective Multicenter Trial of a Small-Aperture Intraocular Lens in Cataract Surgery” showed that at six months, visual acuities, safety and patient satisfaction for the IC-8 IOL were excellent. Implantation of the small-aperture IC-8 IOL in one eye and a companion monofocal IOL in the other eye during cataract surgery provides a continuous, uninterrupted range of vision with excellent near and far visual acuities. At six months, uncorrected distance, intermediate and near vision in the IC-8 IOL eyes were 20/23, 20/24 and 20/30 respectively. Binocular vision was 20/32 or better for far, intermediate and near vision in 99%, 95% and 79% of patients respectively. An exceptionally high percentage  of patients (95.9%) reported they would have the procedure again.

Lead investigator Dr. H. Burkhard Dick, Chairman of the University Eye Hospital Bochum, Germany, explained that the IC-8 lens provides good vision at all distances, even in cases where astigmatism or myopia remain. “Patients achieved up to 2.50 D of functional range of vision without loss at distance in their IC-8 IOL eye, and we found that visual acuities were virtually unaffected by a residual corneal astigmatism below 1.50 D. The IOL’s continuous depth of focus, tolerance for refractive misses and high patient satisfaction make it a valuable surgical option.”

“We are excited about this very successful study of the IC-8 IOL, which represents the first application our proven small-aperture method for extending depth of focus to an IOL platform,” said Al Waterhouse, President and COO of AcuFocus. “The procedure was completed safely, with excellent visual acuity and high patient satisfaction ratings, even in imperfect cases.

The IC-8 IOL is a game-changing lens for patients and surgeons alike.” The IC-8 IOL is CE Marked and currently available in select European and Asia Pacific markets. The U.S. clinical trial for the IC-8 IOL is anticipated to begin in 2018.

 

ABOUT ACUFOCUS
AcuFocus, Inc., is a privately held ophthalmic medical device company that develops and markets breakthrough technologies for the improvement of near vision. The Company’s proven, proprietary technology platforms use a small aperture – or pinhole – to allow only focused light rays to reach the retina and bring objects into clear focus. The result is unique, reliable and long-lasting performance. Using the small aperture concept, two products have been developed: the Company’s flagship product – the KAMRA® corneal inlay – and the innovative IC-8 intraocular lens. The KAMRA inlay helps presbyopic patients restore their near vision while maintaining their far vision. It is commercially available in 50 countries, including the United States. The IC-8 intraocular lens provides a range of vision across various distances, from near to far, and is specifically designed for patients with cataracts. The IC-8 IOL is CE Marked and currently available in select markets and is not approved by the FDA for use in the U.S. Founded in 2001, AcuFocus is based in Irvine, California.