The primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) to reduce postoperative refractive error and improve uncorrected distance visual acuity in eyes with prior corneal refractive surgery. A control group consisting of fellow eyes implanted with a commercially available IOL will be used to compare the safety and effectiveness of the LAL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Primary eye will receive Light adjustable lens with Light delivery Device treatments
Fellow eye will receive control IOL
Discover Vision Centers
Leawood, Kansas, United States
Cleveland Eye Clinic
Brecksville, Ohio, United States
Vance Thompson Vision Clinic
Sioux Falls, South Dakota, United States
Slade & Baker Vision
Houston, Texas, United States
Focal Point Vision
San Antonio, Texas, United States
The Eye Institute of Utah
Salt Lake City, Utah, United States
Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control
Time frame: Postop Month 6
Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
Time frame: Postop Month 6
One Sided Upper 95% Confidence Limit of the Percentage of LAL Implanted Eyes With BCDVA of 20/40 or Better is Higher Than the Performance Rate of 92.5%
Time frame: Postop Month 6
Uncorrected Distance Visual Acuity (UCDVA)
Time frame: Postop Month 6
Uncorrected Distance Visual Acuity (UCDVA) for Subjects Measured With Keratometric Cylinder (Kcyl) <0.75 D in Both Eyes at the Preoperative Examination
Time frame: Postop Month 6
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