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217 LASIK Study

As a LASIK trainer for over 6 years and one of the original pioneers of the Technolas 217 scanning laser, Dr. Machat was asked to be a lead international investigator for the Technolas laser FDA trials in January 1999. These trials are independently monitored and verified and are the most vigorously controlled clinical evaluations of an excimer laser. Patients must undergo 6 months of rigorous and controlled pre- and post-operative testing. While most clinical statistics quoted by surgeons are unsubstantiated, the FDA clinical outcomes are verified by independent monitors. There is no input from either the surgeon or the center.

The Technolas 217 scanning laser is equipped with PlanoScan 2000 software and utilizes a flying spot delivery system which scans a 2mm spot across an 8 to 9 mm zone to correct myopia, hyperopia and astigmatism. The laser is equipped with an active eyetracking system which follows the eye during treatment to improve clinical results and safety. It should be noted that the eyetracker was not utilized during FDA trials so patients now having the procedure with Dr. Machat routinely have even more advances available to them.

"The LASIK clinical results demonstrated by Dr. Machat during the trials were simply the best ever reported for LASIK in such a study", stated Dr. Stephen Slade, Medical Monitor for the FDA trial at the European Society of Cataract and Refractive Surgery Meeting in Vienna, Austria in September 1999.

CRS LASIK premarket approval cohort data Summit Visx Dr.Machat
Eyes 1013 723 213
Efficacy - UCV 20/40 or better 92% 95% 99.5%
UCVA 20/20 or better      
7 D preop myopia 51% 63% 84%
Manifest Refraction      
0.5 D 61% 74% 91.7%
1.0 D 84% 91% 98.7%
Stability-<1-D change from 3-6 months 94% 95% 99.3%
Safety-BSCVA lost 2 or more lines 1.9% 0.6% 0%
Induced Astigmatism 1% 0% 0%
Adverse Events <1% <1% 0%

Clinical results from other similar but less rigorous trials are at left for comparison. (The CRS trials were multi-center physician monitored LASIK trials which were submitted to the FDA for LASIK approval of both the Summit and Visx lasers.)

It is also important to note that during the clinical study none of Dr. Machat's patients encountered any corneal flap
complications resulting in any loss of best corrected vision. Therefore an exceptional safety record complimented the superb clinical results.

Although the clinical study only evaluated mild to severe myopia and astigmatism, Dr. Machat has been routinely treating hyperopia, hyperopic astigmatism and mixed astigmatism since 1996.

Dr. Jeffery J. Machat Statistics
First LASIK: 1994
Total number of LASIK procedures 1994-2000: 28,000
Average number of LASIK procedures over the past 3 years: 5,000/year
Corneal Flap Complications: < 1/2000 in the past two years