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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

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
Myopic Astigmatism
Device: Amadeus Microkeratome
Device: IntraLase

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00366574

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

No publications provided Identifier: NCT00366574     History of Changes
Other Study ID Numbers: MRC-05-003
Study First Received: August 17, 2006
Last Updated: August 17, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Eye Diseases
Refractive Errors processed this record on November 25, 2014