Evaluation of Outcomes Following LASIK Surgery Using CustomVue

Sponsor
Medical University of South Carolina (Other)
Overall Status
Completed
CT.gov ID
NCT00366769
Collaborator
(none)
30
5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Wavefront-guided LASIK using CustomVue platform
N/A

Study Design

Study Type:
Interventional
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 :
Sep 1, 2005
Study Completion Date :
Feb 1, 2006

Outcome Measures

Primary Outcome Measures

  1. Visual acuity []

  2. Induction of high order aberrations []

Secondary Outcome Measures

  1. Contrast sensitivity & glare []

  2. Patient satisfaction []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Medical University of South Carolina

Investigators

  • Principal Investigator: Kerry D. Solomon, MD, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00366769
Other Study ID Numbers:
  • MRC-05-005
First Posted:
Aug 21, 2006
Last Update Posted:
Aug 21, 2006
Last Verified:
Mar 1, 2006
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2006