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Evaluation of Outcomes Following LASIK Surgery Using CustomVue

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00366769
First Posted: August 21, 2006
Last Update Posted: August 21, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University of South Carolina
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00366769


Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Kerry D. Solomon, MD Medical University of South Carolina
  More Information

ClinicalTrials.gov Identifier: NCT00366769     History of Changes
Other Study ID Numbers: MRC-05-005
First Submitted: August 17, 2006
First Posted: August 21, 2006
Last Update Posted: August 21, 2006
Last Verified: March 2006

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases