AcuFocus is committed “to continuously adapting and expanding” its small aperture technology. The company’s first device, the KAMRA, received US regulatory approval in April 2015, and the firm has begun a slow launch. In development is the IC-8 intraocular lens (IOL). To date, AcuFocus has “extensive clinical data” on about 200 patients.
The IC-8 already has a CE mark in Europe.The IC-8 is a small aperture IOL, a standard single piece hydrophobic acrylic IOL. It is currently in a multisite European clinical study. Initial results indicate a very broad degree of image resolution, confirmed by initial modular transfer function curves. Small aperture optics provide a single image, eliminating the need for the eye’s visual system to overlay one image on top of another as it does in multifocal lens types. That, in turn, can decrease the image quality and potentially have a detrimental effect on contrast sensitivity.
By using the IC-8 in one eye in conjunction with a monofocal lens in the other eye\, the patient will be provided an expanded depth of focus that is “very tolerant” to refractive error, Dr. Tarantino said. Initial data show the IC-8 can produce 20/20 at distance and intermediate and a little better than 20/32 at near (40 cm). The company has been studying targeted correction to about –0.75 D; because the IOL is “very tolerant to both sphere and cylinder,” most patients who achieve 20/25 at 40 cm at near are without appreciable loss of distance acuity (20/20). The lens has not shown any loss of contrast sensitivity. The IC-8 has been designed so that surgical implantation at a 6 and 12 orientation is the same as standard phacoemulsification procedures. The lens does not prohibit or complicate posterior views as confirmed with visual field, fundus photography, and retina optical coherence tomography. It also will not interfere with other surgical techniques (epiretinal membrane peels, laser photocoagulation, etc.).
Nicholas Tarantino, OD
Nick Tarantino, OD is Chief Clinical and Regulatory Officer and Head of R&D for AcuFocus, Inc., a company specializing in innovative solutions for the treatment of presbyopia.