Comparison of a Laser Keratome to a Mechanical Microkeratome

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT00366574
• Collaborator: (none)
• Enrollment: 20
• Duration (Months): 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Astigmatism; Myopic Astigmatism	Device: Amadeus Microkeratome; Device: IntraLase	N/A

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Comparison of INTRALASE® to AMADEUS™ Microkeratome
• Study Start Date: Sep 1, 2004
• Study Completion Date: Feb 1, 2005

Outcome Measures

Primary Outcome Measures

1. Visual acuity []

2. Contrast sensitivity []

3. Induction of high order aberration []

4. Corneal sensation []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Medical University of South Carolina

Investigators

• Principal Investigator: Kerry D. Solomon, MD, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00366574
• Other Study ID Numbers: MRC-05-003
• First Posted: Aug 21, 2006
• Last Update Posted: Aug 21, 2006
• Last Verified: Mar 1, 2005

• Additional relevant MeSH terms: Astigmatism

Study Results

No Results Posted as of Aug 21, 2006