Ophthalmic medical device company AcuFocus, Inc. announced yesterday that the first US patient has been implanted with the IC-8 small aperture intraocular lens (IOL) as part of its pivotal study of the IC-8 lens in cataract patients. The company recently announced approval for an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration to conduct the study.
The IC-8 IOL is a clear monofocal lens with an embedded mini-ring or pinhole in the center. This novel lens is designed to increase a patient’s natural range of vision by extending the focus of light rays that enter the eye and restricting peripheral defocused light rays.
This prospective, multicenter, parallel-group study will enroll approximately 475 patients with bilateral cataracts. Participants in the IC-8 lens test group will receive a standard monofocal IOL in their first eye and if visual requirements are met, the IC-8 IOL in their second eye. Participants in the control group will receive bilateral monofocal IOLs. Participants will be followed for 12 months and evaluated for improvement in their vision at all distances.
“The IDE study design is unique. The IC-8 lens test group must meet an initial set of enrollment criteria, and a secondary set of enrollment criteria based on the results of the first eye,” said Dr. Kevin Waltz, co-medical monitor for the IC-8 lens clinical trial. “To have the first IC-8 IOL implant placed so quickly after IDE approval is impressive.”
More information about the study can be found at www.IC8lensclinicalstudy.com.