VISX's FDA clinical study results were remarkable. Among other things:
- At one year after the VISX CustomVue procedure;
- 100% of the clinical study participants could pass a driving test without glasses or contacts
- 98% of the clinical study participants could see 20/20 or better without glasses or contacts
- 70% of the clinical study participants could see 20/16 or better without glasses or contacts
- Four times as many clinical study participants were very satisfied with their night vision after the VISX CustomVue procedure, compared to their night vision before with glasses or contacts.
History
Wavefront technology was first developed in 1978 by Josef Bille, Ph.D., director of the Institute for Applied Physics at the University of Heidelberg, to measure wavefront distortions that occurred when light traveling through the atmosphere entered a telescopic lens. This technology removed any visual distortion or aberrations from the atmosphere allowing astrophysicists to more accurately view images of the stars and planets.
It is now possible to utilize this technology to record detailed information about the visual characteristics of the eye. Unlike standard measuring devices such as corneal topography, which measure the front surface of the eye called the cornea, the wavefront scans the way the entire optical system processes light.
“Fingerprint” of the EyeWavefront analysis works by measuring the distortion or irregularities of the eye, known as higher-order aberrations. When a ray of light first enters the eye, it passes through the cornea to the lens and vitreous, ultimately reaching the retina. As it bounces off the retina and returns back through the cornea, the wavefront analysis detects and documents these distortions, which are unique to each individual. Because each patient has a unique visual optical system, the wavefront data has been likened to a fingerprint.
Custom LASIK
Once the wavefront data has been documented for an individual patient, the next step is to use this information to utilize the excimer laser to correct the higher-order visual aberrations. The surgeon can then determine what adjustments must be made to the corneal surface to produce a clear, crisp image for the unique individual needs of each patient. The use of wavefront technology to provide a more precise laser vision correction is known as, "Custom LASIK" or "Wavefront-Driven LASIK". Early data suggests that the 5-10 percent of patients who demonstrate higher-order aberrations are the patients that will significantly benefit from Custom LASIK treatments.
