The objective of this study is to evaluate the efficacy and subject satisfaction with three different FDA approved lenses for adults over 40 years of age who desire a reduction in spectacle dependence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
78
Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Bausch & Lomb, Inc
Aliso Viejo, California, United States
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Postoperative visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Postoperative visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Postoperative visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Postoperative visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
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Time frame: Postoperative visit 4 ( 4-6 months)
Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Postoperative visit 4 ( 4-6 months)
Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Postoperative visit 4 ( 4-6 months)
Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Postoperative visit 4 ( 4-6 months)
Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Postoperative visit 4 ( 4-6 months)
Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 3 (2-3 months)
Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time frame: Visit 4 (4-6 months)
Optical Scatter
Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.
Time frame: Visit 3 (2-3 months)
Optical Scatter
Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.
Time frame: Visit 4 (4-6 months)
Monocular Halo and Starburst
Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.
Time frame: Visit 3 (2-3 months)
Monocular Halo and Starburst
Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.
Time frame: Visit 4 (4-6 months)
Binocular Halo and Starburst
Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.
Time frame: Visit 3 (2-3 months)
Binocular Halo and Starburst
Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.
Time frame: Visit 4 (4-6 months)
Manifest Refraction
Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.
Time frame: Visit 3 (2-3 Months)
Manifest Refraction
Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.
Time frame: Visit 4 (4-6 Months)
Uncorrected Distance Visual Acuity
High Contrast Uncorrected Distance (UCDVA) measured at 32 inches, Intermediate (UCIVA) at 32 inches, and Near Visual Acuity (UCNVA) at 16 inches
Time frame: Visit 3 (2-3 months) Visit 4 (4-6 months)
Best-corrected Distance Visual Acuity
High Contrast Distance-Corrected Distance,(BCDVA), Intermediate (DCIVA), and Near Visual Acuity (DCNVA)
Time frame: Visit 3 (2-3 months) Visit 4 (4-6 months)