Alcon Inc has received approval from the U.S. Food & Drug Administration (FDA) for its advanced laser eye surgery system, called the LADARVision System, for customized wavefront-guided laser eye surgery in the treatment of nearsightedness.
With this newly approved system, made up of the LADARVision 4000 excimer laser system and the new LADARWave diagnostic device, surgeons can, for the first time, measure and treat visual disorders that previously could not be detected. This highly customized approach creates a new laser eye surgery procedure, called LADARVision CustomCornea, that improves both visual acuity, which is measured against standard numerical outcomes such as 20/20, and the overall quality of vision, such as increased visual crispness and clarity. Visual acuity of 20/20, considered by most as the standard for vision, has been traditionally measured by a letter chart, which does not provide for detection of many of the disorders that may affect vision.
Several types of imperfections, referred to as lower- and higher-order aberrations, exist within the eye and can affect both a person's visual acuity and the quality of vision. To date, only lower-order aberrations, which include nearsightedness, farsightedness and astigmatism, could be measured and treated. However, lower-order aberrations do not account for all potential vision disorders. Higher-order aberrations can also have a significant impact on a person's quality of vision, and cannot be corrected with glasses, contacts or conventional LASIK. According to experts in the field of ophthalmology, higher-order aberrations are linked to visual disturbances such as glare and halos that may cause night vision problems and are sometimes associated with conventional LASIK surgery.
The LADARVision System is the first-and-only FDA approved eye surgery system that can measure both lower- and higher-order aberrations, and can actually be used to treat each patient's unique pattern of lower- and higher-order visual errors.
"LADARVision CustomCornea is a tremendous breakthrough in laser eye surgery that raises the bar in this field," says Stephen Brint, clinical associate professor of ophthalmology, Tulane University School of Medicine, who, as the first surgeon in the U.S. to perform LASIK surgery, is also the medical director of the FDA clinical trials.
In LADARVision CustomCornea clinical trials, nearly 90 percent of patients who underwent the new laser eye surgery procedure achieved 20/20 vision, but even more importantly, they reported a quality of vision superior to that achieved with conventional LASIK.