Clinical Trial: Safety and Effectiveness of Wavefront-Guided LASIK Correction of Hyperopic Refractive Errors

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 Hyperopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and Star S4 IR&

Brief Summary: Demonstrate that wavefront-guided LASIK using measurements from the iDesign System is safe and effective for the treatment of Hyperopia.

Detailed Summary:
Sponsor: Abbott Medical Optics

Current Primary Outcome: Line loss for Best Spectacle Corrected Visual Acuity (BSCVA) [ Time Frame: 9 Months ]

<5% of eyes with a loss of > 2 lines of Best Spectacle Corrected Visual Acuity


Original Primary Outcome: Same as current

Current Secondary Outcome: Uncorrected Visual Acuity (VA) 20/40 or better [ Time Frame: 9 Months ]

85% of eyes with uncorrected visual acuity of 20/40 or better


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: April 4, 2017
Last Verified: April 2017