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NCT00366574 Clinical Trial

Comparison of a Laser Keratome to a Mechanical Microkeratome

Myopia Clinical Trial

Official title:
Comparison of INTRALASE® to AMADEUS™ Microkeratome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00366574
Other study ID # MRC-05-003
Secondary ID
Status Completed
Phase N/A
First received August 17, 2006
Last updated August 17, 2006
Start date September 2004
Est. completion date February 2005

Study information
Verified date March 2005
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date February 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Device:
• Amadeus Microkeratome

• IntraLase

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Medical University of South Carolina

Outcome
Type Measure Description Time frame Safety issue
Primary Visual acuity
Primary Contrast sensitivity
Primary Induction of high order aberration
Primary Corneal sensation
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