Evaluation of 3 Intraocular Lenses Following Lens Extraction

Phase 4

Completed

Conditions: Cataract

Interventions: Device: ReSTOR
Device: Tecnis Multifocal IOL
Device: Crystalens AO

Registration Number: NCT01122576

Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 78

Inclusion Criteria

Subjects must have a clinically documented diagnosis of age-related bilateral cataracts that are considered amenable to treatment with standard phacoemulsification cataract extraction.
Subjects must require a spherical lens power from 10.00 D to 33.00 D
Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32 or better in both eyes, as documented by a Potential Acuity Meter

Exclusion Criteria

Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome. Zonular rupture during cataract surgery may affect postoperative centration, tilt, and stability of the lens.
Subjects who have any active inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis.
Subjects with visually significant diabetic retinopathy (proliferative or non-proliferative) which reduces potential acuity to 20/32 or worse.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ReSTOR	ReSTOR	Eligible subjects to undergo small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
Tecnis Multifocal IOL	Tecnis Multifocal IOL	Eligible subjects to undergo small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Crystalens AO	Crystalens AO	Eligible subjects to undergo small incision cataract surgery and were implanted with the Crystalens AO bilaterally.

Primary Outcome Measures

Name	Time	Method
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree	Postoperative visit 3 (2-3 months)	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
Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree	Postoperative visit 4 ( 4-6 months)	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
Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree	Postoperative visit 4 ( 4-6 months)	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
Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree	Postoperative visit 4 ( 4-6 months)	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
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree	Postoperative visit 4 ( 4-6 months)	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
Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree	Postoperative visit 4 ( 4-6 months)	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

Secondary Outcome Measures

Name	Time	Method
Monocular Halo and Starburst	Visit 4 (4-6 months)	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.
Binocular Halo and Starburst	Visit 4 (4-6 months)	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.
Manifest Refraction	Visit 4 (4-6 Months)	Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.
Uncorrected Distance Visual Acuity	Visit 3 (2-3 months) Visit 4 (4-6 months)	High Contrast Uncorrected Distance (UCDVA) measured at 32 inches, Intermediate (UCIVA) at 32 inches, and Near Visual Acuity (UCNVA) at 16 inches
Best-corrected Distance Visual Acuity	Visit 3 (2-3 months) Visit 4 (4-6 months)	High Contrast Distance-Corrected Distance,(BCDVA), Intermediate (DCIVA), and Near Visual Acuity (DCNVA)
Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree	Visit 3 (2-3 months)	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
Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree	Visit 3 (2-3 months)	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
Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree	Visit 4 (4-6 months)	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
Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree	Visit 4 (4-6 months)	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
Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree	Visit 4 (4-6 months)	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
Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree	Visit 4 (4-6 months)	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
Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree	Visit 4 (4-6 months)	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
Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree	Visit 4 (4-6 months)	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
Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree	Visit 4 (4-6 months)	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
Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree	Visit 4 (4-6 months)	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
Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree	Visit 4 (4-6 months)	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
Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree	Visit 4 (4-6 months)	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
Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree	Visit 4 (4-6 months)	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
Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree	Visit 4 (4-6 months)	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
Optical Scatter	Visit 4 (4-6 months)	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.