Comparison of a Laser Keratome to a Mechanical Microkeratome

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. Identifier: NCT00366574
Recruitment Status : Completed
First Posted : August 21, 2006
Last Update Posted : August 21, 2006
Information provided by:
Medical University of South Carolina

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myopia Astigmatism Myopic Astigmatism Device: Amadeus Microkeratome Device: IntraLase Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Comparison of INTRALASE® to AMADEUS™ Microkeratome
Study Start Date : September 2004
Study Completion Date : February 2005

Primary Outcome Measures :
  1. Visual acuity
  2. Contrast sensitivity
  3. Induction of high order aberration
  4. Corneal sensation

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00366574

Sponsors and Collaborators
Medical University of South Carolina
Principal Investigator: Kerry D. Solomon, MD Medical University of South Carolina Identifier: NCT00366574     History of Changes
Other Study ID Numbers: MRC-05-003
First Posted: August 21, 2006    Key Record Dates
Last Update Posted: August 21, 2006
Last Verified: March 2005

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases