AcuFocus announced the publication of a European post-market study with its extended depth-of-focus small-aperture IC-8 IOL in the Journal of Cataract & Refractive Surgery.
The prospective, open label, multicenter clinical study titled “Prospective Multicenter Trial of a Small-Aperture Intraocular Lens in Cataract Surgery” showed that at 6 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 6 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," Dr. Dick said in a company news release.
“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,” Al Waterhouse, President and COO of AcuFocus, said in the news release. “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 US clinical trial for the IC-8 IOL is anticipated to begin in 2018.