FDA Approved Excimer Lasers Summary
by Adam on Mar.23, 2009, under LASIK, Technology
Listed Contraindications for LASIK performed by all excimer laser platforms:
- Pregnant or nursing
- Keratoconus
- Collagen Vascular, Autoimmune, or Immunodeficiency disorders
- Taking Accutane or Cordarone
- Prescription changes in last year of 0.5 D or more.
There are 4 commonly used excimer lasers in the US. The two most common are the Wavelight Allegretto Wave and the VISX Star Customvue. Carl Zeiss MEL-80 and the Bausch and Lomb 217Z are also in operation as well. If a LASIK surgeon has continually upgraded the platform throughout the years, then the excimer laser system is of secondary concern. Each of the systems can provide over 90% chance of 20/20 uncorrected vision for moderate near-sighted prescription. Certain lasers run faster than others. Others require less corneal ablation. Outdated lasers, however, are to be avoided. They are nowhere near as accurate as the newer technologies.
Approved: Aug 11th, 2006
Approved for up to -7.00 D Myopia and -3.00 D Astigmatism
Approved for Ages 21 and older
193 nm laser
250 Hz laser
0.7 mm spot diameter
Infrared tracking, 250 Hz speed
Ablation debris removal system
Gaussian beam
Optical zone 6-7 mm
Results:
88 Myopic Eyes (avg. -3.9 D)
272 Astigmatic Eyes (avg. spherical -3.37, avg. cylinder -0.975)
92.7% achieved 20/20 or better
99.4% achieved 20/40 or better
Approved: Oct. 10th, 2003
Approved for up to -12.00 D Myopia and -6.00 D Astigmatism
Approved for up to +5.00 D Hyperopia
Approved for Ages 18 and older
193 nm laser
200 Hz laser
0.95 mm spot size
Optical zone 4.5-8 mm
Results:
901 Eyes (avg. spherical -4.45, avg cylinder -0.846)
87.4% achieved 20/20 or better
99.0% achieved 20/40 or better
Approved: Feb 23rd, 2000
Approved for up to -7.00 D Myopia and -3.00 D Astigmatism
Approved for Ages 21 and older
193 nm laser
50 Hz laser
120 Hz eyetracker
2 mm spot diameter
Results:
100 Myopic Eyes (avg. spherical -3.86)
276 Astigmatic Eyes (avg. spherical -3.59, avg. cylinder -1.07)
84.8% achieved 20/20 or better
99.4% achieved 20/40 or better
Newer 100 Hz lasers with wavefront correction are now available that have improved results over the Bausch and Lomb Technolas 217A. These include changes to the Eye tracking, wavefront correction, and ablation profile changes.
Approved: Nov 19th, 1999
Approved for up to -12.00 D Myopia and -4.00 D Astigmatism
Approved for up to +6.00 D Hyperopia
Approved for Ages 18 and older
193 nm laser
Newer upgrades include:
Variable Spot Scanning
Iris Registration
3D Eye Tracking
Results:
Results of the 1999 FDA Approved VISX laser are no longer appropriate as newer platforms have made significant changes. If your LASIK surgeon uses a VISX excimer laser, make certain that your surgeon has updated the VISX laser with all suggested changes from the manufacturer, including Variable Spot Scanning, Iris Registration, 3D Eye Tracking, and Wavefront Correction profiles with Fourier Analysis.
