Evaluation of Visual Outcomes After Myopic LASIK

This study has been completed.
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00366743
First received: August 17, 2006
Last updated: NA
Last verified: June 2005
History: No changes posted
  Purpose

The aim of the study was to evaluate visual outcomes, contrast sensitivity, glare testing and high order aberrations induced by different laser technologies and to evaluate differences in aberrometer technology. We hypothesized that there will not be differences among conventional or wavefront guided treatments.


Condition Intervention
Myopia
Astigmatism
Myopic Astigmatism
Procedure: Conventional LASIK
Procedure: Wavefront-guided LASIK

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Analysis of Visual Outcomes, Contrast Sensitivity, Glare, Induction of High Order Aberrations and Wavefront Technology, Following LASIK Surgery

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

Primary Outcome Measures:
  • Visual acuity
  • Contrast sensitivity
  • Induction of high order aberrations

Estimated Enrollment: 120
Study Start Date: May 2003
Estimated Study Completion Date: June 2005
Detailed Description:

The aim of the study was to evaluate and compare visual outcomes, contrast sensitivity, glare testing and induction of high order aberrations by different laser technologies and to evaluate differences in aberrometer technology.

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Candidates for bilateral LASIK
  • Myopic range: 0.00 to -7.00 D
  • Astigmatism: 0.00 to -5.00 D

Exclusion Criteria:

  • Pupil size greater than 8mm diameter, infrared measurement
  • thin corneas (preoperatively calculated minimal residual bed < 250 um)
  • irregular astigmatism
  • asymmetric astigmatism
  • unstable refraction
  • other criteria that preclude the patient to undergo 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: NCT00366743

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: NCT00366743     History of Changes
Other Study ID Numbers: MRC-05-001
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 October 19, 2014