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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
  Purpose
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 Intervention
Myopia Astigmatism Myopic Astigmatism Device: Amadeus Microkeratome Device: IntraLase

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Comparison of INTRALASE® to AMADEUS™ Microkeratome

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Visual acuity
  • Contrast sensitivity
  • Induction of high order aberration
  • Corneal sensation

Estimated Enrollment: 20
Study Start Date: September 2004
Estimated Study Completion Date: February 2005
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00366574


Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Kerry D. Solomon, MD Medical University of South Carolina
  More Information

ClinicalTrials.gov Identifier: NCT00366574     History of Changes
Other Study ID Numbers: MRC-05-003
First Submitted: August 17, 2006
First Posted: August 21, 2006
Last Update Posted: August 21, 2006
Last Verified: March 2005

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases