Evaluation of Outcomes Following LASIK Surgery Using CustomVue

This study has been completed.

Sponsored by:	Medical University of South Carolina
Information provided by:	Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00366769

Purpose

The aim of the study was to evaluate visual outcomes, contrast sensitivity, glare and induced high order aberrations induced by the new CustomVue software use for wavefront-guided LASIK.

Condition	Intervention
Myopia Astigmatism Myopic Astigmatism	Device: Wavefront-guided LASIK using CustomVue platform

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment
Official Title:	Evaluation of Visual Outcomes, Contrast Sensitivity, Glare, and Induction of High Order Aberrations Following LASIK Surgery Using CustomVue

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

Primary Outcome Measures:

Visual acuity
Induction of high order aberrations

Secondary Outcome Measures:

Contrast sensitivity & glare
Patient satisfaction

Estimated Enrollment:	30
Study Start Date:	September 2005
Estimated Study Completion Date:	February 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Myopia 0.00 to -6.00 D
Astigmatism 0.00 up to -3.00 D
Manifest refraction spherical equivalent (MRSE) up to -6.00 D.

Exclusion Criteria:

History of ocular pathology
Previous ocular surgery
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 condition that precludes the patient from undergoing LASIK

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366769

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-05-005
Study First Received:	August 17, 2006
Last Updated:	August 17, 2006
ClinicalTrials.gov Identifier:	NCT00366769
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