The primary objective of this study is to conduct a post-approval study which compares the LAL to a monofocal control IOL for safety outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
500
Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments
Control treatment group will receive a Control IOL
Vold Vision
Fayetteville, Arkansas, United States
Reeve Woods Eye Center
Chico, California, United States
The Eye Institute of West Florida
Largo, Florida, United States
Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
Time frame: Postop Month 6
Absolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control
Time frame: Postop Month 6
Rate of Endothelial Cell Density Loss
The median difference was compared against a 5% non-inferiority margin for endothelial cell density loss using a right-tail Mann-Whitney-Wilcoxon test with a significance level of 0.05.
Time frame: Postop Month 6
Rate of Retinal Findings
Rate of retinal findings in the Light adjustable lens (LAL) and Light Delivery Device (LDD) treatment group only.
Time frame: Postop Month 6
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