The purpose of this study is to evaluate the safety and effectiveness of the WaveLight EX500 excimer laser system for the correction of myopia with and without astigmatism using InnovEyes in conjunction with InnovEyes sightmap.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/40 or Better (in Eyes With Preoperative Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better) at Refractive Stability
Timeframe: Preoperative Visit (Day -30 to Day -1), Month 1, Month 3
Percentage of Eyes With Manifest Refractive Spherical Equivalent (MRSE) Within +/- 0.50 Diopter (D) at Refractive Stability
Timeframe: Month 1, Month 3
Percentage of Eyes With MRSE Within +/- 1.00 D at Refractive Stability
Timeframe: Month 1, Month 3
Percentage of Eyes That Achieve Refractive Stability Assessed as Change From Baseline in MRSE of Equal to or Less Than 1.0 D
Timeframe: Preoperative Visit (Day -30 to Day -1), Month 1, Month 3
Percentage of Eyes With BCDVA Worse Than 20/40 (With BCDVA 20/20 or Better Preoperatively) at Refractive Stability
Timeframe: Day -30 to -1 (preoperative), up to Month 3
Percentage of Eyes With BCDVA Loss of 2 Lines (10 Letters) or More From Preoperative Visit at Refractive Stability
Timeframe: Day -30 to -1 (preoperative), up to Month 3
Percentage of Eyes With Increase of Manifest Refractive Astigmatism Greater Than 2.00 Diopter (D) of Absolute Cylinder Compared to Preoperative Visit at Refractive Stability
Timeframe: Day -30 to -1 (preoperative), up to Month 3
Percentage of Eyes With Non-flap Related Ocular Serious Adverse Events at Refractive Stability
Timeframe: Up to Month 3