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Clinical Trials/NCT00366574
NCT00366574CompletedNot Applicable

Comparison of INTRALASE® to AMADEUS™ Microkeratome

Medical University of South Carolina0 sites20 target enrollmentStarted: September 1, 2004Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Primary Endpoint
Visual acuity
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Visual acuity

Contrast sensitivity

Induction of high order aberration

Corneal sensation

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

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