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Evaluation of Outcomes Following LASIK Surgery Using CustomVue

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ClinicalTrials.gov Identifier: NCT00366769
Recruitment Status : Completed
First Posted : August 21, 2006
Last Update Posted : August 21, 2006
Sponsor:
Information provided by:
Medical University of South Carolina

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Myopia Astigmatism Myopic Astigmatism Device: Wavefront-guided LASIK using CustomVue platform Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
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
Study Start Date : September 2005
Study Completion Date : February 2006
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Visual acuity
  2. Induction of high order aberrations

Secondary Outcome Measures :
  1. Contrast sensitivity & glare
  2. Patient satisfaction

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases