Evaluation of Visual Outcomes After Myopic LASIK - Full Text View

Sponsored by:	Medical University of South Carolina
Information provided by:	Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00366743

Purpose

The aim of the study was to evaluate visual outcomes, contrast sensitivity, glare testing and high order aberrations induced by different laser technologies and to evaluate differences in aberrometer technology. We hypothesized that there will not be differences among conventional or wavefront guided treatments.

Condition	Intervention
Myopia Astigmatism Myopic Astigmatism	Procedure: Conventional LASIK Procedure: Wavefront-guided LASIK

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title:	Analysis of Visual Outcomes, Contrast Sensitivity, Glare, Induction of High Order Aberrations and Wavefront Technology, Following LASIK Surgery

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:

Visual acuity
Contrast sensitivity
Induction of high order aberrations

Estimated Enrollment:	120
Study Start Date:	May 2003
Estimated Study Completion Date:	June 2005

Detailed Description:

The aim of the study was to evaluate and compare visual outcomes, contrast sensitivity, glare testing and induction of high order aberrations by different laser technologies and to evaluate differences in aberrometer technology.

Eligibility

Ages Eligible for Study:	21 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years or older
Candidates for bilateral LASIK
Myopic range: 0.00 to -7.00 D
Astigmatism: 0.00 to -5.00 D

Exclusion Criteria:

Pupil size greater than 8mm diameter, infrared measurement
thin corneas (preoperatively calculated minimal residual bed < 250 um)
irregular astigmatism
asymmetric astigmatism
unstable refraction
other criteria that preclude the patient to undergo LASIK

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366743

Sponsors and Collaborators

Medical University of South Carolina

Investigators

Principal Investigator:

Kerry D. Solomon, MD

Medical University of South Carolina

More Information

Study ID Numbers:	MRC-05-001
Study First Received:	August 17, 2006
Last Updated:	August 17, 2006
ClinicalTrials.gov Identifier:	NCT00366743
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Eye Diseases
Myopia
Refractive Errors
Astigmatism

ClinicalTrials.gov processed this record on January 16, 2009