Back to resultsEvaluation of Outcomes Following LASIK Surgery Using CustomVue
Primary Purpose
Myopia, Astigmatism, Myopic Astigmatism
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Wavefront-guided LASIK using CustomVue platform
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Visual acuity
Induction of high order aberrations
Secondary Outcome Measures
Contrast sensitivity & glare
Patient satisfaction
Full Information
NCT ID
NCT00366769
First Posted
August 17, 2006
Last Updated
August 17, 2006
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT00366769
Brief Title
Evaluation of Outcomes Following LASIK Surgery Using CustomVue
Official Title
Evaluation of Visual Outcomes, Contrast Sensitivity, Glare, and Induction of High Order Aberrations Following LASIK Surgery Using CustomVue
Study Type
Interventional
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of South Carolina
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Astigmatism, Myopic Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Wavefront-guided LASIK using CustomVue platform
Primary Outcome Measure Information:
Title
Visual acuity
Title
Induction of high order aberrations
Secondary Outcome Measure Information:
Title
Contrast sensitivity & glare
Title
Patient satisfaction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry D. Solomon, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Outcomes Following LASIK Surgery Using CustomVue
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