Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on September 26, 2016