Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Comparison of a Laser Keratome to a Mechanical Microkeratome

This study has been completed.
Information provided by:
Medical University of South Carolina Identifier:
First received: August 17, 2006
Last updated: NA
Last verified: March 2005
History: No changes posted

August 17, 2006
August 17, 2006
September 2004
Not Provided
  • Visual acuity
  • Contrast sensitivity
  • Induction of high order aberration
  • Corneal sensation
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
Comparison of a Laser Keratome to a Mechanical Microkeratome
Comparison of INTRALASE® to AMADEUS™ Microkeratome

The purpose of this study was to evaluate the performance of the INTRALASE®, a laser keratome which creates a corneal flap, and compare it to a mechanical microkeratome (Amadeus™). Our hypothesis is that there is no difference between the 2 devices.

Not Provided
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Myopia
  • Astigmatism
  • Myopic Astigmatism
  • Device: Amadeus Microkeratome
  • Device: IntraLase
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2005
Not Provided

Inclusion Criteria:

  • Candidate for bilateral wavefront-guided LASIK
  • Myopia up to -7.00 D
  • Astigmatism of 0.00 to -1.50 D

Exclusion Criteria:

  • History of ocular pathology
  • Previous ocular surgery
  • Very large pupils (greater than 8mm diameter, infrared measurement)
  • Thin corneas (preoperatively calculated minimal residual bed < 250 um)
  • Irregular astigmatism
  • Asymmetric astigmatism
  • Unstable refraction
  • Any other criteria that precludes subject to undergo LASIK
18 Years and older
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Medical University of South Carolina
Not Provided
Principal Investigator: Kerry D. Solomon, MD Medical University of South Carolina
Medical University of South Carolina
March 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP