Comparison of a Laser Keratome to a Mechanical Microkeratome

Medical University of South Carolina20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Myopia Astigmatism Myopic Astigmatism

Interventions

Amadeus MicrokeratomeDEVICE

IntraLaseDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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