Comparison of a Laser Keratome to a Mechanical Microkeratome

Not Applicable

Completed

• Conditions: Myopia; Astigmatism; Myopic Astigmatism

• Registration Number: NCT00366574
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study Completion: 2005-02
• Status Verified: 2005-03
• Study First Submitted: 2006-08-17
• Study First Submitted QC: 2006-08-17
• Last Update Submitted: 2006-08-17
• Study First Posted: 2006-08-21
• Last Update Posted: 2006-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual acuity
Contrast sensitivity
Induction of high order aberration
Corneal sensation