Caution: Investigational Device.
Limited by Federal Law to Investigational Use in the United States.
Age-related macular degeneration is the leading cause of visual impairment with a significant associated morbidity in the United States and many other developed counties. The prevalence of visually significant macular degeneration in the U.S. is currently 2,000,000 people (somewhat less than 4,000,000 eyes) and expected to increase to 3,600,000 people by 2030. World-wide, macular degeneration is affecting 32,000,000 people. These people with moderate to severe disability from macular degeneration, and this level of visual disability prevents most from meaningful employment, reading, recreation, and participation in activities of daily living (ADLs).
Based upon our benchtop testing, our coupled lens design allows the eye's natural feedback system to alter the focus more than 12 diopters of accommodation, with maximum image quality throughout this range. As a result, the need for magnification through telescopes, video magnifiers, and other external devices is potentially eliminated. The automatically focusing lens is designed to be affordable while providing surgeons with a unique IOL solution requiring minimal retraining. Our Conexus IOL LensTM utilizes currently available silicone lens materials and is engineered to be implanted using standard surgical procedures (less than 3mm incision).
Conexus already demonstrated the conceptual feasibility of our approach through both mechanical and optical modeling. Our design approach is comparatively simple and provides the ophthalmic surgeon a valuable alternative for macular degeneration patients in need of cataract surgery. It also varies only minimally from existing cataract surgery procedures. Presently, most ophthalmologists implant a fixed focus lens setting the patient to about +3.00 diopters of near-sightedness in order to maximize image magnification of the retina with the use of external low vision aids.
We are finalizing the conceptual feasibility through mechanical & optical modeling, and we are preparing to proceed with biomechanical testing and clinical trials. The Conexus IOL LensTM is an investigational device and is not available for sale or use at this time.