We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of a Laser Keratome to a Mechanical Microkeratome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00366574
First Posted: August 21, 2006
Last Update Posted: August 21, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University of South Carolina
August 17, 2006
August 21, 2006
August 21, 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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00366574
MRC-05-003
Not Provided
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