Clinical Trial: Safety and Effectiveness of Wavefront-guided LASIK for the Correction of Mixed Astigmatism

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided LASIK Correction of Mixed Astigmatic Refractive Errors With the iDESIGN Advanced Wavescan Studio™ System and STAR

Brief Summary: To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and effective in the treatment of mixed astigmatism.

Detailed Summary:
Sponsor: Abbott Medical Optics

Current Primary Outcome: Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA) [ Time Frame: 3 Months ]

< 5% of eyes will have a loss of > 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters


Original Primary Outcome: Same as current

Current Secondary Outcome: Uncorrected Visual Acuity (UCVA) of 20/40 or Better [ Time Frame: 3 Months ]

85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters


Original Secondary Outcome: Same as current

Information By: Abbott Medical Optics

Dates:
Date Received: August 28, 2012
Date Started: December 2012
Date Completion:
Last Updated: May 23, 2017
Last Verified: May 2017