Comparison of a Laser Keratome to a Mechanical Microkeratome

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Myopia; Astigmatism; Myopic Astigmatism

Treatments: Device: Amadeus Microkeratome; Device: IntraLase

Study type: Interventional

Funder types: Other

Identifiers

NCT00366574

MRC-05-003

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind