Clinical Trial: Safety and Effectiveness of Arcuate Incisions Performed With the iFS Femtosecond Laser System

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

Official Title: A Multi-Center Prospective Study to Evaluate the Safety and Effectiveness of Arcuate Incisions Performed With the IntraLase iFS Femtosecond Laser System

Brief Summary: To determine if arcuate incisions performed with the iFS femtosecond laser are safe and effective in reducing corneal astigmatism.

Detailed Summary: Surgeons will perform arcuate incisions in the cornea in arc segment patterns using the iFS femtosecond laser to treat subjects with corneal astigmatism.
Sponsor: Abbott Medical Optics

Current Primary Outcome: Reduction of Astigmatism [ Time Frame: 6 months ]

Reduction of astigmatism as determined by manifest refractive cylinder


Original Primary Outcome: Reduction of Astigmatism [ Time Frame: 12 months ]

Current Secondary Outcome: Percent of Eyes With Loss of ≥ 2 Lines of Best Spectacle Corrected Visual Acuity (BSCVA) [ Time Frame: 6 months ]

Original Secondary Outcome: Percent of eyes with loss of >/= 2 lines of BSCVA [ Time Frame: 12 months ]

Information By: Abbott Medical Optics

Dates:
Date Received: May 4, 2011
Date Started: May 2011
Date Completion:
Last Updated: May 6, 2014
Last Verified: May 2014