Myopia Clinical Trial
Official title:
A Prospective Study to Evaluate the Feasibility of a New Treatment Algorithm for Wavefront-Guided Lasik Correction of Myopic Refractive Errors
The purpose of this clinical trial is to demonstrate that treatments generated by an investigational algorithm reduces spherical aberration compared to currently available iDesign treatments.
Post-LASIK induction of spherical aberration is currently among the most prominent challenges for refractive surgery. The presence of significant spherical aberration in the visual system results in reduced contrast sensitivity, visual symptoms such as "glare" and "halos," and "night myopia" or the induction of myopia under low lighting (larger pupil size). A modified Treatment Planning Software (TPS) "VSS-Rx1 OPM software" has been developed that uses a modified algorithm (software that designs the LASIK treatment profile) to limit the induction of postoperative spherical aberration. Commercially available software used to calculate the LASIK treatment profile was used in one eye (active comparator [i.e., control]) and VSS-Rx1 OPM software was used in the fellow eye (experimental). Subjects were masked to the use of either the commercially available or VSS-Rx1 OPM software. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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