Carl Zeiss Meditec, Inc., announced in April that the FDA had granted the company conditional approval to initiate a clinical trial of the ReLEx small-incision lenticular extraction (smile) procedure for the correction of myopia with its VisuMax Femtosecond Laser. The clinical trial will initially include five sites in the United States. Patients will undergo LASIK in one eye and ReLEx smile in the fellow eye. Initially, my fellow investigators and I will treat spherical myopia in patients with 0.50 D or less of astigmatism and a spherical error of -1.00 to -8.00 D. As the trial advances, we will begin to include bilateral cases and the treatment of astigmatism. To date, nine eyes have been treated in Denver.
Clinical outcomes outside the United States have met or exceeded the results of state-of-the-art LASIK. Data from the international sites mirror current LASIK results with predictability: 95% of the eyes are ±0.50 D within the refractive target. Interestingly, the predictability has been just as high for patients with low myopia as it has for those with high myopia. In terms of efficacy, 95% of the eyes have achieved an uncorrected distance visual acuity of at least 20/30 at 3 months for even moderate to high levels of myopia. Importantly, safety has been excellent, with only 1% to 2% of eyes losing 2 or more lines of BSCVA. Refractive stability has essentially been achieved at 1 week, and little to no change has been seen between this interval and the 1- and 3-month data sets (data on file with Carl Zeiss Meditec, Inc.).
John F. Doane, MD, is in private practice with Discover Vision Centers in Kansas City, Missouri, and he is a clinical assistant professor with the Department of Ophthalmology, Kansas University Medical Center in Kansas City, Kansas. He is reimbursed for clinical study overhead costs by Carl Zeiss Meditec, Inc. Dr. Doane may be reached at (816) 478-1230; firstname.lastname@example.org.