This purpose of this study is to evaluate the safety and effectiveness of a topography-based custom ablation treatment using the ALLEGRETTO WAVE® Eye-Q 400 Hz laser system for treating myopia and hyperopia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
212
Milauskas Eye Institute
La Quinta, California, United States
Gordon & Weiss Vision Institute
San Diego, California, United States
Woolfson Eye Institute
Atlanta, Georgia, United States
Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 0.50 D
Time frame: 12 month
Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 1.00 D
Time frame: 12 month
Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 2.00 D
Time frame: 12 month
Percentage of Eyes With Uncorrected Visual Acuity (UCVA) 20/20 or Better
Time frame: 12 month
Percentage of Eyes With UCVA 20/40 or Better if BSCVA 20/20 or Better Preoperatively
Time frame: 12 month
Percentage of Eyes With Loss of 2 or More Lines Best Spectacle-Corrected Visual Acuity (BSCVA)
Time frame: 12 month
Percentage of Eyes With Best Spectacle-Corrected Visual Acuity (BSCVA) Worse Than 20/40
Time frame: 12 month
Percentage of Eyes With an Increase > 2D Cylinder (Spherical Only)
Time frame: 12 month
Percentage of Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) Worse Than 20/40 if 20/20 or Better Preoperatively
Time frame: 12 month
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Emory Vision
Atlanta, Georgia, United States
Bond Eye Associates
Peoria, Illinois, United States
Durrie Vision
Overland Park, Kansas, United States
TLC Laser Eye Center
Greensboro, North Carolina, United States
Memorial Eye Institute
Harrisburg, Pennsylvania, United States
Laser Vision of Texas
Houston, Texas, United States
International Eye Care Laser Center
Houston, Texas, United States