Evaluation of Outcomes Following LASIK Surgery Using CustomVue

This study has been completed.
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00366769
First received: August 17, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
  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: 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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00366769     History of Changes
Other Study ID Numbers: MRC-05-005
Study First Received: August 17, 2006
Last Updated: August 17, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Astigmatism
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014