Comparison of a Laser Keratome to a Mechanical Microkeratome

This study has been completed.

Sponsor:

Information provided by:

Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT00366574

First received: August 17, 2006

Last updated: NA

Last verified: March 2005

History: No changes posted

Tracking Information

First Received Date ^ICMJE

August 17, 2006

Last Updated Date

August 17, 2006

Start Date ^ICMJE

September 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Visual acuity
Contrast sensitivity
Induction of high order aberration
Corneal sensation

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of a Laser Keratome to a Mechanical Microkeratome

Official Title ^ICMJE

Comparison of INTRALASE® to AMADEUS™ Microkeratome

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Myopia
Astigmatism
Myopic Astigmatism

Intervention ^ICMJE

Device: Amadeus Microkeratome
Device: IntraLase

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00366574

Other Study ID Numbers ^ICMJE

MRC-05-003

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Medical University of South Carolina

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kerry D. Solomon, MD

Medical University of South Carolina

Information Provided By

Medical University of South Carolina

Verification Date

March 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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