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Dr. Donald Bennett was among the first group of U.S. surgeons certified
to perform custom ablations on the VISX Star S3 laser. The Custom-CAP
Method is used for the treatment of asymmetrical ablation patters
from previous laser refractive surgery caused by decentration of the
treatment as viewed on the Zeiss Humphrey topography unit and treated
with the VISX Star s# ActiveTrak Excimer Laser System.
The Custom CAP method was approved by the FDA under a Humanitarian
Device Exemption. An HDE is similar to a premarket approval application
(PMA), but exempt from the requirements of a PMA. HDE regulations
require an Institutional Review Board to review and monitor these
treatments. The Custom CAP method is approved for either PRK or LASIK
and only qualified patients are eligible for treatment. |
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