Back to resultsEvaluation of 3 Intraocular Lenses Following Lens Extraction
Primary Purpose
Cataract
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Crystalens AO
ReSTOR
Tecnis Multifocal IOL
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Intra Ocular Lens, Ocular surgery, Phacoemulsification
Eligibility Criteria
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.
Sites / Locations
- Bausch & Lomb, Inc
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Crystalens AO
ReSTOR
Tecnis Multifocal IOL
Arm Description
Eligible subjects to undergo small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Eligible subjects to undergo small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
Eligible subjects to undergo small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Outcomes
Primary Outcome Measures
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
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
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
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
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
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
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
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
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
Secondary Outcome Measures
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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.
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.
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.
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.
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.
Manifest Refraction
Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.
Manifest Refraction
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
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
High Contrast Distance-Corrected Distance,(BCDVA), Intermediate (DCIVA), and Near Visual Acuity (DCNVA)
Full Information
NCT ID
NCT01122576
First Posted
May 11, 2010
Last Updated
February 12, 2014
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01122576
Brief Title
Evaluation of 3 Intraocular Lenses Following Lens Extraction
Official Title
A Three Arm Prospective Clinical Evaluation of Three FDA Approved Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Intra Ocular Lens, Ocular surgery, Phacoemulsification
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Crystalens AO
Arm Type
Experimental
Arm Description
Eligible subjects to undergo small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Arm Title
ReSTOR
Arm Type
Active Comparator
Arm Description
Eligible subjects to undergo small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
Arm Title
Tecnis Multifocal IOL
Arm Type
Active Comparator
Arm Description
Eligible subjects to undergo small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Intervention Type
Device
Intervention Name(s)
Crystalens AO
Intervention Description
Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
Intervention Type
Device
Intervention Name(s)
ReSTOR
Intervention Description
ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
Intervention Type
Device
Intervention Name(s)
Tecnis Multifocal IOL
Intervention Description
Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Primary Outcome Measure Information:
Title
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree
Description
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)
Title
Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree
Description
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)
Title
Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree
Description
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)
Title
Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree
Description
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)
Title
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree
Description
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)
Title
Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree
Description
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)
Title
Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree
Description
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)
Title
Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree
Description
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)
Title
Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree
Description
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)
Secondary Outcome Measure Information:
Title
Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree
Description
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)
Title
Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree
Description
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)
Title
Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree
Description
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)
Title
Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree
Description
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)
Title
Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree
Description
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)
Title
Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree
Description
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)
Title
Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree
Description
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)
Title
Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree
Description
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)
Title
Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree
Description
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)
Title
Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree
Description
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)
Title
Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree
Description
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)
Title
Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree
Description
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)
Title
Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree
Description
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)
Title
Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree
Description
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)
Title
Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree
Description
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)
Title
Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree
Description
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)
Title
Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree
Description
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)
Title
Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree
Description
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)
Title
Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree
Description
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)
Title
Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree
Description
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)
Title
Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree
Description
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)
Title
Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree
Description
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)
Title
Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree
Description
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)
Title
Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree
Description
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)
Title
Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree
Description
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)
Title
Optical Scatter
Description
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)
Title
Optical Scatter
Description
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)
Title
Monocular Halo and Starburst
Description
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)
Title
Monocular Halo and Starburst
Description
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)
Title
Binocular Halo and Starburst
Description
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)
Title
Binocular Halo and Starburst
Description
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)
Title
Manifest Refraction
Description
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)
Title
Manifest Refraction
Description
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)
Title
Uncorrected Distance Visual Acuity
Description
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)
Title
Best-corrected Distance Visual Acuity
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omid Khodai, OD, RAC
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb, Inc
City
Aliso Viejo
State/Province
California
ZIP/Postal Code
92656
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of 3 Intraocular Lenses Following Lens Extraction
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