Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Three Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01225952
Recruitment Status : Completed
First Posted : October 21, 2010
Results First Posted : January 18, 2013
Last Update Posted : January 18, 2013
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cataract
Interventions Device: Crystalens AO
Device: ReSTOR 3.0
Device: AMO Tecnis Multifocal
Enrollment 93
Recruitment Details This study was an evaluation of three United States Food and Drug Administration (FDA) approved IOLs. A total of 93 participants(186 eyes) were enrolled at one investigative site in the Philippines. First participant was enrolled 7/15/2010 and last participant exited the study 4/28/2011.
Pre-assignment Details 186 participant eyes were enrolled in this study 154 participant eyes completed the study. Participants underwent bilateral phacoemulsification and IOL implantation. Participants were randomized to treatment groups prior to surgery.
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region. A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Period Title: Overall Study
Started 31 31 31
Completed 25 27 25
Not Completed 6 4 6
Reason Not Completed
Lost to Follow-up             1             0             0
Study Eye Explanted             0             0             1
Withdrawal by Subject             4             4             5
Surgical complications             1             0             0
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal Total
Hide Arm/Group Description Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region. A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL Total of all reporting groups
Overall Number of Baseline Participants 31 31 31 93
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 31 participants 93 participants
< 40 years 0 0 0 0
40 - 49 years 2 1 0 3
50 - 59 years 6 8 7 21
60 - 69 years 13 14 16 43
70 - 79 years 10 8 7 25
>/= 80 years 0 0 1 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 31 participants 93 participants
Female
23
  74.2%
25
  80.6%
22
  71.0%
70
  75.3%
Male
8
  25.8%
6
  19.4%
9
  29.0%
23
  24.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Philippines Number Analyzed 31 participants 31 participants 31 participants 93 participants
31 31 31 93
1.Primary Outcome
Title Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree)
Hide Description A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 3 (day 30-60)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 26 27 25
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
52 54 50
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.5 cycles/degree 1.612  (0.229) 1.582  (0.231) 1.527  (0.248)
3 cycles/degree 1.658  (0.195) 1.627  (0.224) 1.629  (0.240)
2.Primary Outcome
Title Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
Hide Description A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 3 (day 30-60)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set, non-missing
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 26 25 24
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
51 50 48
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.641  (0.210) 1.611  (0.237) 1.641  (0.286)
3.Primary Outcome
Title Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
Hide Description A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 3 (day 30-60)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set, non-missing
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 24 22 21
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
48 43 42
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.325  (0.226) 1.227  (0.198) 1.324  (0.281)
4.Primary Outcome
Title Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
Hide Description A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 3 (day 30-60)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set, non-missing
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 17 13 15
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
34 26 30
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
0.977  (0.266) 0.985  (0.185) 0.973  (0.342)
5.Primary Outcome
Title Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
Hide Description A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 4 (day 120-180)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 25 27 25
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
50 54 50
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.5 cycles/degree 1.696  (0.213) 1.621  (0.222) 1.527  (0.190)
3 cycles/degree 1.678  (0.159) 1.670  (0.236) 1.630  (0.203)
6.Primary Outcome
Title Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
Hide Description A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 4 (day 120-180)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 24 26 24
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
48 51 48
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.579  (0.239) 1.499  (0.230) 1.610  (0.228)
7.Primary Outcome
Title Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
Hide Description A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 4 (day 120-180)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 20 18 20
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
39 35 40
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.280  (0.245) 1.225  (0.253) 1.230  (0.248)
8.Primary Outcome
Title Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
Hide Description A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 4 (day 120-180)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 13 10 9
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
25 20 18
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
0.974  (0.303) 0.980  (0.246) 0.976  (0.207)
9.Secondary Outcome
Title Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
Hide Description In two eye (Binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 3 (day 30-60)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 26 27 25
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.5 cycles/degree 1.770  (0.187) 1.656  (0.238) 1.605  (0.203)
3 cycles/degree 1.807  (0.199) 1.679  (0.275) 1.689  (0.189)
10.Secondary Outcome
Title Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
Hide Description In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 3 (day 30-60)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 25 26 25
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.825  (0.216) 1.591  (0.274) 1.700  (0.284)
11.Secondary Outcome
Title Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
Hide Description In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 3 (day 30-60)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 25 21 22
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.425  (0.221) 1.335  (0.218) 1.361  (0.278)
12.Secondary Outcome
Title Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
Hide Description In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 3 (day 30-60)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 19 15 16
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.029  (0.250) 1.001  (0.213) 0.981  (0.362)
13.Secondary Outcome
Title Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
Hide Description In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 4 (day 120-180)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 25 27 25
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.5 cycles/degree 1.797  (0.183) 1.751  (0.238) 1.577  (0.206)
3 cycles/degree 1.851  (0.178) 1.723  (0.239) 1.702  (0.219)
14.Secondary Outcome
Title Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
Hide Description In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 4 (day 120-180)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 24 25 24
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.758  (0.280) 1.640  (0.236) 1.690  (0.263)
15.Secondary Outcome
Title Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
Hide Description In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 4 (day 120-180)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 21 18 22
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.371  (0.247) 1.269  (0.257) 1.310  (0.286)
16.Secondary Outcome
Title Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
Hide Description In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 4 (day 120-180)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 16 12 12
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.115  (0.299) 0.995  (0.384) 1.041  (0.330)
17.Secondary Outcome
Title Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)
Hide Description In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 3 (day 30-60)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 26 25 25
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
52 50 49
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.591  (0.215) 1.519  (0.218) 1.482  (0.268)
18.Secondary Outcome
Title Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree)
Hide Description In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 3 (day 30-60)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 26 25 24
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
52 50 47
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.687  (0.229) 1.581  (0.204) 1.588  (0.264)
19.Secondary Outcome
Title Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)
Hide Description In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 3 (day 30-60)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 25 25 23
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
50 49 45
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.674  (0.237) 1.531  (0.238) 1.626  (0.293)
20.Secondary Outcome
Title Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)
Hide Description In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 3 (day 30-60)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 23 18 17
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
45 35 34
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.328  (0.224) 1.230  (0.223) 1.340  (0.268)
21.Secondary Outcome
Title Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)
Hide Description In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 3 (day 30-60)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 14 12 13
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
27 24 25
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.024  (0.196) 0.945  (0.158) 0.834  (0.283)
22.Secondary Outcome
Title Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)
Hide Description In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 4 (day 120-180)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 25 25 24
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
50 50 48
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.550  (0.263) 1.488  (0.226) 1.449  (0.206)
23.Secondary Outcome
Title Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree)
Hide Description In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 4 (day 120-180)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 25 25 25
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
50 50 49
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.664  (0.258) 1.572  (0.225) 1.535  (0.220)
24.Secondary Outcome
Title Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)
Hide Description In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 4 (day 120-180)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 24 23 23
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
48 46 45
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.578  (0.252) 1.493  (0.267) 1.519  (0.260)
25.Secondary Outcome
Title Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)
Hide Description In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 4 (day 120-180)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 20 15 16
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
39 30 31
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
1.335  (0.298) 1.246  (0.278) 1.194  (0.237)
26.Secondary Outcome
Title Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)
Hide Description In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame Postoperative visit 4 (day 120-180)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description:
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Overall Number of Participants Analyzed 13 8 8
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
25 16 16
Mean (Standard Deviation)
Unit of Measure: log contrast sensitivity units
0.919  (0.283) 1.019  (0.367) 0.935  (0.207)
Time Frame 120-180 days
Adverse Event Reporting Description Adverse events measured by eye
 
Arm/Group Title Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Hide Arm/Group Description Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region. A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
All-Cause Mortality
Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/53 (0.00%)      0/54 (0.00%)      0/51 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Crystalens AO ReSTOR 3.0 AMO Tecnis Multifocal
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/53 (22.64%)      5/54 (9.26%)      6/51 (11.76%)    
Eye disorders       
Increased Intraocular Pressure  1  11/53 (20.75%)  11 5/54 (9.26%)  5 3/51 (5.88%)  3
Cystoid Macular Edema  1  1/53 (1.89%)  1 0/54 (0.00%)  0 3/51 (5.88%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s)after the review by, and in consultation and agreement with the Sponsor.
Results Point of Contact
Name/Title: Omid Khodai, OD,RAC
Organization: Bausch & Lomb Incorporated
Phone: (949) 521-7894
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01225952     History of Changes
Other Study ID Numbers: 656
First Submitted: October 19, 2010
First Posted: October 21, 2010
Results First Submitted: August 31, 2012
Results First Posted: January 18, 2013
Last Update Posted: January 18, 2013