Trial Outcomes & Findings for Three Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction (NCT NCT01225952)
NCT ID: NCT01225952
Last Updated: 2013-01-18
Results Overview
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.
COMPLETED
PHASE4
93 participants
Postoperative visit 3 (day 30-60)
2013-01-18
Participant Flow
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.
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.
Participant milestones
| Measure |
Crystalens AO
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
31
|
|
Overall Study
COMPLETED
|
25
|
27
|
25
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
6
|
Reasons for withdrawal
| Measure |
Crystalens AO
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Study Eye Explanted
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
5
|
|
Overall Study
Surgical complications
|
1
|
0
|
0
|
Baseline Characteristics
Three Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction
Baseline characteristics by cohort
| Measure |
Crystalens AO
n=31 Participants
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=31 Participants
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=31 Participants
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
< 40 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Age, Customized
40 - 49 years
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Age, Customized
50 - 59 years
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Age, Customized
60 - 69 years
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
16 participants
n=5 Participants
|
43 participants
n=4 Participants
|
|
Age, Customized
70 - 79 years
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
25 participants
n=4 Participants
|
|
Age, Customized
>/= 80 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Region of Enrollment
Philippines
|
31 participants
n=5 Participants
|
31 participants
n=7 Participants
|
31 participants
n=5 Participants
|
93 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Postoperative visit 3 (day 30-60)Population: Full Analysis Set
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.
Outcome measures
| Measure |
Crystalens AO
n=52 eyes
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=54 eyes
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=50 eyes
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree)
1.5 cycles/degree
|
1.612 log contrast sensitivity units
Standard Deviation 0.229
|
1.582 log contrast sensitivity units
Standard Deviation 0.231
|
1.527 log contrast sensitivity units
Standard Deviation 0.248
|
|
Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree)
3 cycles/degree
|
1.658 log contrast sensitivity units
Standard Deviation 0.195
|
1.627 log contrast sensitivity units
Standard Deviation 0.224
|
1.629 log contrast sensitivity units
Standard Deviation 0.240
|
PRIMARY outcome
Timeframe: Postoperative visit 3 (day 30-60)Population: Full Analysis Set, non-missing
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.
Outcome measures
| Measure |
Crystalens AO
n=51 eyes
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=50 eyes
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=48 eyes
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
|
1.641 log contrast sensitivity units
Standard Deviation 0.210
|
1.611 log contrast sensitivity units
Standard Deviation 0.237
|
1.641 log contrast sensitivity units
Standard Deviation 0.286
|
PRIMARY outcome
Timeframe: Postoperative visit 3 (day 30-60)Population: Full Analysis Set, non-missing
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.
Outcome measures
| Measure |
Crystalens AO
n=48 eyes
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=43 eyes
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=42 eyes
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
|
1.325 log contrast sensitivity units
Standard Deviation 0.226
|
1.227 log contrast sensitivity units
Standard Deviation 0.198
|
1.324 log contrast sensitivity units
Standard Deviation 0.281
|
PRIMARY outcome
Timeframe: Postoperative visit 3 (day 30-60)Population: Full Analysis Set, non-missing
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.
Outcome measures
| Measure |
Crystalens AO
n=34 eyes
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=26 eyes
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=30 eyes
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
|
0.977 log contrast sensitivity units
Standard Deviation 0.266
|
0.985 log contrast sensitivity units
Standard Deviation 0.185
|
0.973 log contrast sensitivity units
Standard Deviation 0.342
|
PRIMARY outcome
Timeframe: Postoperative visit 4 (day 120-180)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.
Outcome measures
| Measure |
Crystalens AO
n=50 eyes
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=54 eyes
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=50 eyes
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
1.5 cycles/degree
|
1.696 log contrast sensitivity units
Standard Deviation 0.213
|
1.621 log contrast sensitivity units
Standard Deviation 0.222
|
1.527 log contrast sensitivity units
Standard Deviation 0.190
|
|
Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
3 cycles/degree
|
1.678 log contrast sensitivity units
Standard Deviation 0.159
|
1.670 log contrast sensitivity units
Standard Deviation 0.236
|
1.630 log contrast sensitivity units
Standard Deviation 0.203
|
PRIMARY outcome
Timeframe: Postoperative visit 4 (day 120-180)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.
Outcome measures
| Measure |
Crystalens AO
n=48 eyes
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=51 eyes
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=48 eyes
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
|
1.579 log contrast sensitivity units
Standard Deviation 0.239
|
1.499 log contrast sensitivity units
Standard Deviation 0.230
|
1.610 log contrast sensitivity units
Standard Deviation 0.228
|
PRIMARY outcome
Timeframe: Postoperative visit 4 (day 120-180)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.
Outcome measures
| Measure |
Crystalens AO
n=39 eyes
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=35 eyes
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=40 eyes
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
|
1.280 log contrast sensitivity units
Standard Deviation 0.245
|
1.225 log contrast sensitivity units
Standard Deviation 0.253
|
1.230 log contrast sensitivity units
Standard Deviation 0.248
|
PRIMARY outcome
Timeframe: Postoperative visit 4 (day 120-180)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.
Outcome measures
| Measure |
Crystalens AO
n=25 eyes
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=20 eyes
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=18 eyes
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
|
0.974 log contrast sensitivity units
Standard Deviation 0.303
|
0.980 log contrast sensitivity units
Standard Deviation 0.246
|
0.976 log contrast sensitivity units
Standard Deviation 0.207
|
SECONDARY outcome
Timeframe: Postoperative visit 3 (day 30-60)Population: Full Analysis Set
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.
Outcome measures
| Measure |
Crystalens AO
n=26 Participants
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=27 Participants
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=25 Participants
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
1.5 cycles/degree
|
1.770 log contrast sensitivity units
Standard Deviation 0.187
|
1.656 log contrast sensitivity units
Standard Deviation 0.238
|
1.605 log contrast sensitivity units
Standard Deviation 0.203
|
|
Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
3 cycles/degree
|
1.807 log contrast sensitivity units
Standard Deviation 0.199
|
1.679 log contrast sensitivity units
Standard Deviation 0.275
|
1.689 log contrast sensitivity units
Standard Deviation 0.189
|
SECONDARY outcome
Timeframe: Postoperative visit 3 (day 30-60)Population: Full Analysis Set
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.
Outcome measures
| Measure |
Crystalens AO
n=25 Participants
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=26 Participants
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=25 Participants
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
|
1.825 log contrast sensitivity units
Standard Deviation 0.216
|
1.591 log contrast sensitivity units
Standard Deviation 0.274
|
1.700 log contrast sensitivity units
Standard Deviation 0.284
|
SECONDARY outcome
Timeframe: Postoperative visit 3 (day 30-60)Population: Full Analysis Set
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.
Outcome measures
| Measure |
Crystalens AO
n=25 Participants
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=21 Participants
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=22 Participants
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
|
1.425 log contrast sensitivity units
Standard Deviation 0.221
|
1.335 log contrast sensitivity units
Standard Deviation 0.218
|
1.361 log contrast sensitivity units
Standard Deviation 0.278
|
SECONDARY outcome
Timeframe: Postoperative visit 3 (day 30-60)Population: Full Analysis Set
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.
Outcome measures
| Measure |
Crystalens AO
n=19 Participants
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=15 Participants
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=16 Participants
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
|
1.029 log contrast sensitivity units
Standard Deviation 0.250
|
1.001 log contrast sensitivity units
Standard Deviation 0.213
|
0.981 log contrast sensitivity units
Standard Deviation 0.362
|
SECONDARY outcome
Timeframe: Postoperative visit 4 (day 120-180)Population: Full Analysis Set
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.
Outcome measures
| Measure |
Crystalens AO
n=25 Participants
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=27 Participants
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=25 Participants
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
1.5 cycles/degree
|
1.797 log contrast sensitivity units
Standard Deviation 0.183
|
1.751 log contrast sensitivity units
Standard Deviation 0.238
|
1.577 log contrast sensitivity units
Standard Deviation 0.206
|
|
Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
3 cycles/degree
|
1.851 log contrast sensitivity units
Standard Deviation 0.178
|
1.723 log contrast sensitivity units
Standard Deviation 0.239
|
1.702 log contrast sensitivity units
Standard Deviation 0.219
|
SECONDARY outcome
Timeframe: Postoperative visit 4 (day 120-180)Population: Full Analysis Set
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.
Outcome measures
| Measure |
Crystalens AO
n=24 Participants
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=25 Participants
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=24 Participants
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
|
1.758 log contrast sensitivity units
Standard Deviation 0.280
|
1.640 log contrast sensitivity units
Standard Deviation 0.236
|
1.690 log contrast sensitivity units
Standard Deviation 0.263
|
SECONDARY outcome
Timeframe: Postoperative visit 4 (day 120-180)Population: Full Analysis Set
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.
Outcome measures
| Measure |
Crystalens AO
n=21 Participants
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=18 Participants
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=22 Participants
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
|
1.371 log contrast sensitivity units
Standard Deviation 0.247
|
1.269 log contrast sensitivity units
Standard Deviation 0.257
|
1.310 log contrast sensitivity units
Standard Deviation 0.286
|
SECONDARY outcome
Timeframe: Postoperative visit 4 (day 120-180)Population: Full Analysis Set
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.
Outcome measures
| Measure |
Crystalens AO
n=16 Participants
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=12 Participants
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=12 Participants
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
|
1.115 log contrast sensitivity units
Standard Deviation 0.299
|
0.995 log contrast sensitivity units
Standard Deviation 0.384
|
1.041 log contrast sensitivity units
Standard Deviation 0.330
|
SECONDARY outcome
Timeframe: Postoperative visit 3 (day 30-60)Population: Full analysis set
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.
Outcome measures
| Measure |
Crystalens AO
n=52 eyes
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=50 eyes
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=49 eyes
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)
|
1.591 log contrast sensitivity units
Standard Deviation 0.215
|
1.519 log contrast sensitivity units
Standard Deviation 0.218
|
1.482 log contrast sensitivity units
Standard Deviation 0.268
|
SECONDARY outcome
Timeframe: Postoperative visit 3 (day 30-60)Population: Full analysis set
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.
Outcome measures
| Measure |
Crystalens AO
n=52 eyes
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=50 eyes
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=47 eyes
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree)
|
1.687 log contrast sensitivity units
Standard Deviation 0.229
|
1.581 log contrast sensitivity units
Standard Deviation 0.204
|
1.588 log contrast sensitivity units
Standard Deviation 0.264
|
SECONDARY outcome
Timeframe: Postoperative visit 3 (day 30-60)Population: Full analysis set
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.
Outcome measures
| Measure |
Crystalens AO
n=50 eyes
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=49 eyes
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=45 eyes
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)
|
1.674 log contrast sensitivity units
Standard Deviation 0.237
|
1.531 log contrast sensitivity units
Standard Deviation 0.238
|
1.626 log contrast sensitivity units
Standard Deviation 0.293
|
SECONDARY outcome
Timeframe: Postoperative visit 3 (day 30-60)Population: Full analysis set
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.
Outcome measures
| Measure |
Crystalens AO
n=45 eyes
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=35 eyes
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=34 eyes
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)
|
1.328 log contrast sensitivity units
Standard Deviation 0.224
|
1.230 log contrast sensitivity units
Standard Deviation 0.223
|
1.340 log contrast sensitivity units
Standard Deviation 0.268
|
SECONDARY outcome
Timeframe: Postoperative visit 3 (day 30-60)Population: Full analysis set
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.
Outcome measures
| Measure |
Crystalens AO
n=27 eyes
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=24 eyes
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=25 eyes
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)
|
1.024 log contrast sensitivity units
Standard Deviation 0.196
|
0.945 log contrast sensitivity units
Standard Deviation 0.158
|
0.834 log contrast sensitivity units
Standard Deviation 0.283
|
SECONDARY outcome
Timeframe: Postoperative visit 4 (day 120-180)Population: Full analysis set
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.
Outcome measures
| Measure |
Crystalens AO
n=50 eyes
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=50 eyes
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=48 eyes
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)
|
1.550 log contrast sensitivity units
Standard Deviation 0.263
|
1.488 log contrast sensitivity units
Standard Deviation 0.226
|
1.449 log contrast sensitivity units
Standard Deviation 0.206
|
SECONDARY outcome
Timeframe: Postoperative visit 4 (day 120-180)Population: Full analysis set
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.
Outcome measures
| Measure |
Crystalens AO
n=50 eyes
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=50 eyes
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=49 eyes
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree)
|
1.664 log contrast sensitivity units
Standard Deviation 0.258
|
1.572 log contrast sensitivity units
Standard Deviation 0.225
|
1.535 log contrast sensitivity units
Standard Deviation 0.220
|
SECONDARY outcome
Timeframe: Postoperative visit 4 (day 120-180)Population: Full analysis set
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.
Outcome measures
| Measure |
Crystalens AO
n=48 eyes
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=46 eyes
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=45 eyes
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)
|
1.578 log contrast sensitivity units
Standard Deviation 0.252
|
1.493 log contrast sensitivity units
Standard Deviation 0.267
|
1.519 log contrast sensitivity units
Standard Deviation 0.260
|
SECONDARY outcome
Timeframe: Postoperative visit 4 (day 120-180)Population: Full analysis set
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.
Outcome measures
| Measure |
Crystalens AO
n=39 eyes
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=30 eyes
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=31 eyes
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)
|
1.335 log contrast sensitivity units
Standard Deviation 0.298
|
1.246 log contrast sensitivity units
Standard Deviation 0.278
|
1.194 log contrast sensitivity units
Standard Deviation 0.237
|
SECONDARY outcome
Timeframe: Postoperative visit 4 (day 120-180)Population: Full analysis set
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.
Outcome measures
| Measure |
Crystalens AO
n=25 eyes
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=16 eyes
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=16 eyes
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)
|
0.919 log contrast sensitivity units
Standard Deviation 0.283
|
1.019 log contrast sensitivity units
Standard Deviation 0.367
|
0.935 log contrast sensitivity units
Standard Deviation 0.207
|
Adverse Events
Crystalens AO
ReSTOR 3.0
AMO Tecnis Multifocal
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Crystalens AO
n=53 participants at risk
Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
|
ReSTOR 3.0
n=54 participants at risk
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
|
AMO Tecnis Multifocal
n=51 participants at risk
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
|
|---|---|---|---|
|
Eye disorders
Increased Intraocular Pressure
|
20.8%
11/53 • Number of events 11 • 120-180 days
Adverse events measured by eye
|
9.3%
5/54 • Number of events 5 • 120-180 days
Adverse events measured by eye
|
5.9%
3/51 • Number of events 3 • 120-180 days
Adverse events measured by eye
|
|
Eye disorders
Cystoid Macular Edema
|
1.9%
1/53 • Number of events 1 • 120-180 days
Adverse events measured by eye
|
0.00%
0/54 • 120-180 days
Adverse events measured by eye
|
5.9%
3/51 • Number of events 3 • 120-180 days
Adverse events measured by eye
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER