Comparison of a Laser Keratome to a Mechanical Microkeratome

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.

Completed

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Key information

Conditions

Myopia Astigmatism Eye Diseases Myopic Astigmatism Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amadeus Microkeratome

Device

IntraLase

Device

Primary outcomes

Visual acuity
Contrast sensitivity
Induction of high order aberration
Corneal sensation

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Comparison of INTRALASE® to AMADEUS™ Microkeratome

Important dates

Study start: 2004
Study completion: 2005
First posted: Aug 21, 2006
Registry last updated: Aug 21, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed