Trial Outcomes & Findings for Evaluation of 3 Intraocular Lenses Following Lens Extraction (NCT NCT01122576)
NCT ID: NCT01122576
Last Updated: 2014-03-28
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
78 participants
Primary outcome timeframe
Postoperative visit 3 (2-3 months)
Results posted on
2014-03-28
Participant Flow
This study took place at two investigative sites in the United States, with the first participant undergoing cataract surgery on 5/18/2010 and last participant completed the study on 6/27/2012.
Seventy eight participants (156 eyes) were enrolled in the study. 148 eyes were analyzed in both the full analysis set and the per protocol set.
Participant milestones
| Measure |
Crystalens AO
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days.
|
ReSTOR
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days.
|
Tecnis Multifocal IOL
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL :Tecnis surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days.
|
|---|---|---|---|
|
Pre-Cataract Surgery
STARTED
|
26
|
26
|
26
|
|
Pre-Cataract Surgery
COMPLETED
|
26
|
25
|
24
|
|
Pre-Cataract Surgery
NOT COMPLETED
|
0
|
1
|
2
|
|
Post-Cataract Surgery
STARTED
|
26
|
25
|
24
|
|
Post-Cataract Surgery
COMPLETED
|
26
|
25
|
22
|
|
Post-Cataract Surgery
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Crystalens AO
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days.
|
ReSTOR
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days.
|
Tecnis Multifocal IOL
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL :Tecnis surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days.
|
|---|---|---|---|
|
Pre-Cataract Surgery
Withdrawal by Subject
|
0
|
1
|
2
|
|
Post-Cataract Surgery
Central Macular Edema
|
0
|
0
|
1
|
|
Post-Cataract Surgery
Fellow Eye Explanted
|
0
|
0
|
1
|
Baseline Characteristics
Evaluation of 3 Intraocular Lenses Following Lens Extraction
Baseline characteristics by cohort
| Measure |
Crystalens AO
n=26 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=26 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=26 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<40 years
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
|
Age, Customized
40 - 49 years
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
2 participants
n=483 Participants
|
|
Age, Customized
50-59 years
|
10 participants
n=93 Participants
|
5 participants
n=4 Participants
|
8 participants
n=27 Participants
|
23 participants
n=483 Participants
|
|
Age, Customized
60-69 years
|
13 participants
n=93 Participants
|
12 participants
n=4 Participants
|
12 participants
n=27 Participants
|
37 participants
n=483 Participants
|
|
Age, Customized
70-79 years
|
3 participants
n=93 Participants
|
8 participants
n=4 Participants
|
4 participants
n=27 Participants
|
15 participants
n=483 Participants
|
|
Age, Customized
≥ 80
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
1 participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
51 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
27 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=93 Participants
|
26 participants
n=4 Participants
|
26 participants
n=27 Participants
|
78 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Postoperative visit 3 (2-3 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=52 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=50 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=44 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree
1.5 cycles/degree
|
1.494 log contrast sensitivity units
Standard Deviation 0.173
|
1.576 log contrast sensitivity units
Standard Deviation 0.209
|
1.410 log contrast sensitivity units
Standard Deviation 0.195
|
|
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree
3 cycles/degree
|
1.613 log contrast sensitivity units
Standard Deviation 0.171
|
1.679 log contrast sensitivity units
Standard Deviation 0.199
|
1.528 log contrast sensitivity units
Standard Deviation 0.175
|
PRIMARY outcome
Timeframe: Postoperative visit 3 (2-3 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=52 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=45 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=40 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree
|
1.563 log contrast sensitivity units
Standard Deviation 0.228
|
1.644 log contrast sensitivity units
Standard Deviation 0.253
|
1.481 log contrast sensitivity units
Standard Deviation 0.212
|
PRIMARY outcome
Timeframe: Postoperative visit 3 (2-3 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=32 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=26 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=17 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree
|
1.155 log contrast sensitivity units
Standard Deviation 0.238
|
1.335 log contrast sensitivity units
Standard Deviation 0.309
|
1.143 log contrast sensitivity units
Standard Deviation 0.189
|
PRIMARY outcome
Timeframe: Postoperative visit 3 (2-3 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=13 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=19 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=5 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree
|
0.943 log contrast sensitivity units
Standard Deviation 0.266
|
0.950 log contrast sensitivity units
Standard Deviation 0.297
|
0.697 log contrast sensitivity units
Standard Deviation 0.138
|
PRIMARY outcome
Timeframe: Postoperative visit 4 ( 4-6 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=52 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=50 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=44 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree
|
1.525 log contrast sensitivity units
Standard Deviation 0.203
|
1.588 log contrast sensitivity units
Standard Deviation 0.213
|
1.408 log contrast sensitivity units
Standard Deviation 0.172
|
PRIMARY outcome
Timeframe: Postoperative visit 4 ( 4-6 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=52 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=49 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=44 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree
|
1.638 log contrast sensitivity units
Standard Deviation 0.243
|
1.698 log contrast sensitivity units
Standard Deviation 0.221
|
1.519 log contrast sensitivity units
Standard Deviation 0.125
|
PRIMARY outcome
Timeframe: Postoperative visit 4 ( 4-6 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=49 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=47 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=41 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree
|
1.610 log contrast sensitivity units
Standard Deviation 0.241
|
1.622 log contrast sensitivity units
Standard Deviation 0.228
|
1.543 log contrast sensitivity units
Standard Deviation 0.261
|
PRIMARY outcome
Timeframe: Postoperative visit 4 ( 4-6 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=33 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=30 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=15 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree
|
1.229 log contrast sensitivity units
Standard Deviation 0.262
|
1.218 log contrast sensitivity units
Standard Deviation 0.238
|
1.217 log contrast sensitivity units
Standard Deviation 0.275
|
PRIMARY outcome
Timeframe: Postoperative visit 4 ( 4-6 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=17 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=11 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=6 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree
|
0.998 log contrast sensitivity units
Standard Deviation 0.297
|
0.789 log contrast sensitivity units
Standard Deviation 0.219
|
0.896 log contrast sensitivity units
Standard Deviation 0.275
|
SECONDARY outcome
Timeframe: Visit 3 (2-3 months)Population: Full set analysis
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
Outcome measures
| Measure |
Crystalens AO
n=25 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=25 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=20 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree
1.5 cycles/degree
|
1.688 log contrast sensitivity units
Standard Deviation 0.221
|
1.749 log contrast sensitivity units
Standard Deviation 0.201
|
1.537 log contrast sensitivity units
Standard Deviation 0.129
|
|
Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree
3 cycles/degree
|
1.775 log contrast sensitivity units
Standard Deviation 0.252
|
1.797 log contrast sensitivity units
Standard Deviation 0.213
|
1.667 log contrast sensitivity units
Standard Deviation 0.168
|
SECONDARY outcome
Timeframe: Visit 3 (2-3 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=25 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=24 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=20 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree
|
1.731 log contrast sensitivity units
Standard Deviation 0.213
|
1.677 log contrast sensitivity units
Standard Deviation 0.257
|
1.593 log contrast sensitivity units
Standard Deviation 0.225
|
SECONDARY outcome
Timeframe: Visit 3 (2-3 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=21 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=15 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=8 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree
|
1.189 log contrast sensitivity units
Standard Deviation 0.170
|
1.362 log contrast sensitivity units
Standard Deviation 0.323
|
1.153 log contrast sensitivity units
Standard Deviation 0.228
|
SECONDARY outcome
Timeframe: Visit 3 (2-3 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=7 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=10 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=3 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree
|
0.965 log contrast sensitivity units
Standard Deviation 0.258
|
0.994 log contrast sensitivity units
Standard Deviation 0.359
|
0.861 log contrast sensitivity units
Standard Deviation 0.241
|
SECONDARY outcome
Timeframe: Visit 4 (4-6 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=26 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=25 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=22 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree
1.5 cycles/degree
|
1.712 log contrast sensitivity units
Standard Deviation 0.212
|
1.743 log contrast sensitivity units
Standard Deviation 0.218
|
1.537 log contrast sensitivity units
Standard Deviation 0.147
|
|
Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree
3 cycles/degree
|
1.785 log contrast sensitivity units
Standard Deviation 0.223
|
1.768 log contrast sensitivity units
Standard Deviation 0.243
|
1.594 log contrast sensitivity units
Standard Deviation 0.135
|
|
Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree
6 cycles/degree
|
1.710 log contrast sensitivity units
Standard Deviation 0.234
|
1.682 log contrast sensitivity units
Standard Deviation 0.268
|
1.595 log contrast sensitivity units
Standard Deviation 0.265
|
SECONDARY outcome
Timeframe: Visit 4 (4-6 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=18 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=17 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=9 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree
|
1.261 log contrast sensitivity units
Standard Deviation 0.291
|
1.273 log contrast sensitivity units
Standard Deviation 0.269
|
1.235 log contrast sensitivity units
Standard Deviation 0.245
|
SECONDARY outcome
Timeframe: Visit 4 (4-6 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=10 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=10 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=5 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree
|
1.160 log contrast sensitivity units
Standard Deviation 0.356
|
1.008 log contrast sensitivity units
Standard Deviation 0.386
|
0.885 log contrast sensitivity units
Standard Deviation 0.287
|
SECONDARY outcome
Timeframe: Visit 3 (2-3 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=50 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=49 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=42 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree
|
1.329 log contrast sensitivity units
Standard Deviation 0.172
|
1.389 log contrast sensitivity units
Standard Deviation 0.219
|
1.233 log contrast sensitivity units
Standard Deviation 0.182
|
SECONDARY outcome
Timeframe: Visit 3 (2-3 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=50 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=48 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=39 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree
|
1.527 log contrast sensitivity units
Standard Deviation 0.190
|
1.518 log contrast sensitivity units
Standard Deviation 0.267
|
1.388 log contrast sensitivity units
Standard Deviation 0.245
|
SECONDARY outcome
Timeframe: Visit 3 (2-3 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=49 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=38 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=27 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree
|
1.514 log contrast sensitivity units
Standard Deviation 0.217
|
1.504 log contrast sensitivity units
Standard Deviation 0.313
|
1.397 log contrast sensitivity units
Standard Deviation 0.265
|
SECONDARY outcome
Timeframe: Visit 3 (2-3 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=27 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=20 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=10 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree
|
1.118 log contrast sensitivity units
Standard Deviation 0.225
|
1.192 log contrast sensitivity units
Standard Deviation 0.235
|
1.059 log contrast sensitivity units
Standard Deviation 0.208
|
SECONDARY outcome
Timeframe: Visit 3 (2-3 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=11 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=8 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=1 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree
|
0.883 log contrast sensitivity units
Standard Deviation 0.199
|
0.989 log contrast sensitivity units
Standard Deviation 0.336
|
0.903 log contrast sensitivity units
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Visit 4 (4-6 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=49 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=49 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=42 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree
|
1.343 log contrast sensitivity units
Standard Deviation 0.254
|
1.367 log contrast sensitivity units
Standard Deviation 0.229
|
1.199 log contrast sensitivity units
Standard Deviation 0.145
|
SECONDARY outcome
Timeframe: Visit 4 (4-6 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=49 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=49 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=41 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree
|
1.536 log contrast sensitivity units
Standard Deviation 0.247
|
1.462 log contrast sensitivity units
Standard Deviation 0.212
|
1.367 log contrast sensitivity units
Standard Deviation 0.196
|
SECONDARY outcome
Timeframe: Visit 4 (4-6 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=46 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=39 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=27 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree
|
1.535 log contrast sensitivity units
Standard Deviation 0.274
|
1.475 log contrast sensitivity units
Standard Deviation 0.276
|
1.413 log contrast sensitivity units
Standard Deviation 0.265
|
SECONDARY outcome
Timeframe: Visit 4 (4-6 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=18 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=14 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=7 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree
|
1.341 log contrast sensitivity units
Standard Deviation 0.341
|
1.272 log contrast sensitivity units
Standard Deviation 0.358
|
1.190 log contrast sensitivity units
Standard Deviation 0.327
|
SECONDARY outcome
Timeframe: Visit 4 (4-6 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=13 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=5 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=5 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree
|
1.139 log contrast sensitivity units
Standard Deviation 0.315
|
1.192 log contrast sensitivity units
Standard Deviation 0.334
|
0.849 log contrast sensitivity units
Standard Deviation 0.353
|
SECONDARY outcome
Timeframe: Visit 3 (2-3 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=24 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=25 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=19 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree
1.5 cycles/degree
|
1.459 log contrast sensitivity units
Standard Deviation 0.239
|
1.439 log contrast sensitivity units
Standard Deviation 0.216
|
1.316 log contrast sensitivity units
Standard Deviation 0.210
|
|
Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree
3 cycles/degree
|
1.609 log contrast sensitivity units
Standard Deviation 0.189
|
1.492 log contrast sensitivity units
Standard Deviation 0.264
|
1.405 log contrast sensitivity units
Standard Deviation 0.225
|
SECONDARY outcome
Timeframe: Visit 3 (2-3 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=24 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=20 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=15 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree
|
1.574 log contrast sensitivity units
Standard Deviation 0.183
|
1.496 log contrast sensitivity units
Standard Deviation 0.385
|
1.412 log contrast sensitivity units
Standard Deviation 0.261
|
SECONDARY outcome
Timeframe: Visit 3 (2-3 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=13 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=8 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=3 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree
|
1.199 log contrast sensitivity units
Standard Deviation 0.243
|
1.337 log contrast sensitivity units
Standard Deviation 0.273
|
1.141 log contrast sensitivity units
Standard Deviation 0.222
|
SECONDARY outcome
Timeframe: Visit 3 (2-3 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=5 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=5 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=2 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree
|
0.980 log contrast sensitivity units
Standard Deviation 0.295
|
1.009 log contrast sensitivity units
Standard Deviation 0.096
|
0.690 log contrast sensitivity units
Standard Deviation 0.125
|
SECONDARY outcome
Timeframe: Visit 4 (4-6 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=25 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=25 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=21 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree
1.5 cycles/degree
|
1.392 log contrast sensitivity units
Standard Deviation 0.222
|
1.404 log contrast sensitivity units
Standard Deviation 0.238
|
1.344 log contrast sensitivity units
Standard Deviation 0.151
|
|
Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree
3 cycles/degree
|
1.573 log contrast sensitivity units
Standard Deviation 0.268
|
1.493 log contrast sensitivity units
Standard Deviation 0.304
|
1.410 log contrast sensitivity units
Standard Deviation 0.223
|
SECONDARY outcome
Timeframe: Visit 4 (4-6 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=25 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=20 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=16 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree
|
1.519 log contrast sensitivity units
Standard Deviation 0.296
|
1.515 log contrast sensitivity units
Standard Deviation 0.330
|
1.448 log contrast sensitivity units
Standard Deviation 0.271
|
SECONDARY outcome
Timeframe: Visit 4 (4-6 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=9 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=8 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=2 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree
|
1.321 log contrast sensitivity units
Standard Deviation 0.331
|
1.319 log contrast sensitivity units
Standard Deviation 0.450
|
1.337 log contrast sensitivity units
Standard Deviation 0.419
|
SECONDARY outcome
Timeframe: Visit 4 (4-6 months)Population: Full analysis set
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
Outcome measures
| Measure |
Crystalens AO
n=6 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=5 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=2 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree
|
1.175 log contrast sensitivity units
Standard Deviation 0.258
|
1.101 log contrast sensitivity units
Standard Deviation 0.439
|
1.060 log contrast sensitivity units
Standard Deviation 0.648
|
SECONDARY outcome
Timeframe: Visit 3 (2-3 months)Population: Full Analysis Set
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.
Outcome measures
| Measure |
Crystalens AO
n=50 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=50 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=45 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Optical Scatter
|
1.1280 units on a scale
Standard Deviation 0.7661
|
1.8080 units on a scale
Standard Deviation 0.8685
|
1.9179 units on a scale
Standard Deviation 0.9751
|
SECONDARY outcome
Timeframe: Visit 4 (4-6 months)Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.
Outcome measures
| Measure |
Crystalens AO
n=52 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=50 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=44 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Optical Scatter
|
1.1308 units on a scale
Standard Deviation 0.7337
|
1.9760 units on a scale
Standard Deviation 1.1630
|
1.8318 units on a scale
Standard Deviation 0.9840
|
SECONDARY outcome
Timeframe: Visit 3 (2-3 months)Population: Full Analysis Set
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.
Outcome measures
| Measure |
Crystalens AO
n=52 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=50 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=45 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Monocular Halo and Starburst
Halo
|
1.2 units on a scale
Standard Deviation 0.9
|
1.3 units on a scale
Standard Deviation 0.8
|
1.8 units on a scale
Standard Deviation 0.9
|
|
Monocular Halo and Starburst
Starburst
|
4.5 units on a scale
Standard Deviation 1.1
|
4.7 units on a scale
Standard Deviation 1.0
|
4.5 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Visit 4 (4-6 months)Population: Full Analysis Set
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.
Outcome measures
| Measure |
Crystalens AO
n=52 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=50 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=44 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Monocular Halo and Starburst
Halo
|
1.2 units on a scale
Standard Deviation 0.6
|
1.5 units on a scale
Standard Deviation 0.8
|
1.8 units on a scale
Standard Deviation 0.7
|
|
Monocular Halo and Starburst
Starburst
|
4.6 units on a scale
Standard Deviation 1.0
|
4.7 units on a scale
Standard Deviation 1.0
|
4.5 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Visit 3 (2-3 months)Population: Full Analysis Set
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.
Outcome measures
| Measure |
Crystalens AO
n=26 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=25 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=22 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Binocular Halo and Starburst
Halo
|
1.2 units on a scale
Standard Deviation 1.1
|
1.4 units on a scale
Standard Deviation 0.8
|
2.0 units on a scale
Standard Deviation 1.0
|
|
Binocular Halo and Starburst
Starburst
|
4.6 units on a scale
Standard Deviation 1.1
|
4.7 units on a scale
Standard Deviation 1.0
|
4.6 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Visit 4 (4-6 months)Population: Full Analysis Set
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.
Outcome measures
| Measure |
Crystalens AO
n=26 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=25 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=22 Participants
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Binocular Halo and Starburst
Halo
|
1.3 units on a scale
Standard Deviation 0.7
|
1.8 units on a scale
Standard Deviation 1.2
|
2.0 units on a scale
Standard Deviation 0.9
|
|
Binocular Halo and Starburst
Starburst
|
4.6 units on a scale
Standard Deviation 1.0
|
4.9 units on a scale
Standard Deviation 0.4
|
4.5 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Visit 3 (2-3 Months)Population: Full Analysis Set
Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.
Outcome measures
| Measure |
Crystalens AO
n=52 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=50 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=45 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Manifest Refraction
|
-0.507 Diopters
Standard Deviation 0.433
|
0.038 Diopters
Standard Deviation 0.344
|
-0.114 Diopters
Standard Deviation 0.362
|
SECONDARY outcome
Timeframe: Visit 4 (4-6 Months)Population: Full Analysis Set
Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.
Outcome measures
| Measure |
Crystalens AO
n=52 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=50 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=44 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Manifest Refraction
|
-0.339 Diopters
Standard Deviation 0.455
|
0.145 Diopters
Standard Deviation 0.370
|
-0.091 Diopters
Standard Deviation 0.339
|
SECONDARY outcome
Timeframe: Visit 3 (2-3 months) Visit 4 (4-6 months)Population: Full Analysis Set
High Contrast Uncorrected Distance (UCDVA) measured at 32 inches, Intermediate (UCIVA) at 32 inches, and Near Visual Acuity (UCNVA) at 16 inches
Outcome measures
| Measure |
Crystalens AO
n=52 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=50 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=46 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Uncorrected Distance Visual Acuity
UCDVA Monocular Visit 3
|
0.122 logMAR
Standard Deviation 0.171
|
0.002 logMAR
Standard Deviation 0.115
|
0.072 logMAR
Standard Deviation 0.150
|
|
Uncorrected Distance Visual Acuity
UCDVA Monocular Visit 4
|
0.113 logMAR
Standard Deviation 0.173
|
0.016 logMAR
Standard Deviation 0.121
|
0.060 logMAR
Standard Deviation 0.148
|
|
Uncorrected Distance Visual Acuity
UCDVA Binocular Visit 3
|
0.005 logMAR
Standard Deviation 0.082
|
-0.054 logMAR
Standard Deviation 0.102
|
-0.048 logMAR
Standard Deviation 0.087
|
|
Uncorrected Distance Visual Acuity
UCDVA Binocular Visit 4
|
-0.026 logMAR
Standard Deviation 0.110
|
-0.061 logMAR
Standard Deviation 0.080
|
-0.053 logMAR
Standard Deviation 0.104
|
|
Uncorrected Distance Visual Acuity
UCIVA Monocular Visit 3
|
0.055 logMAR
Standard Deviation 0.159
|
0.219 logMAR
Standard Deviation 0.150
|
0.237 logMAR
Standard Deviation 0.221
|
|
Uncorrected Distance Visual Acuity
UCIVA Monocular Visit 4
|
0.066 logMAR
Standard Deviation 0.168
|
0.244 logMAR
Standard Deviation 0.158
|
0.237 logMAR
Standard Deviation 0.197
|
|
Uncorrected Distance Visual Acuity
UCIVA Binocular Visit 3
|
-0.012 logMAR
Standard Deviation 0.130
|
0.138 logMAR
Standard Deviation 0.140
|
0.126 logMAR
Standard Deviation 0.169
|
|
Uncorrected Distance Visual Acuity
UCIVA Binocular Visit 4
|
-0.024 logMAR
Standard Deviation 0.111
|
0.169 logMAR
Standard Deviation 0.144
|
0.175 logMAR
Standard Deviation 0.146
|
|
Uncorrected Distance Visual Acuity
UCNVA Monocular Visit 3
|
0.192 logMAR
Standard Deviation 0.189
|
0.005 logMAR
Standard Deviation 0.108
|
0.164 logMAR
Standard Deviation 0.149
|
|
Uncorrected Distance Visual Acuity
UCNVA Monocular Visit 4
|
0.264 logMAR
Standard Deviation 0.195
|
-0.008 logMAR
Standard Deviation 0.120
|
0.188 logMAR
Standard Deviation 0.185
|
|
Uncorrected Distance Visual Acuity
UCNVA Binocular Visit 3
|
0.082 logMAR
Standard Deviation 0.151
|
-0.057 logMAR
Standard Deviation 0.074
|
0.041 logMAR
Standard Deviation 0.109
|
|
Uncorrected Distance Visual Acuity
UCNVA Binocular Visit 4
|
0.133 logMAR
Standard Deviation 0.148
|
-0.061 logMAR
Standard Deviation 0.087
|
0.043 logMAR
Standard Deviation 0.130
|
SECONDARY outcome
Timeframe: Visit 3 (2-3 months) Visit 4 (4-6 months)Population: Full Analysis Set
High Contrast Distance-Corrected Distance,(BCDVA), Intermediate (DCIVA), and Near Visual Acuity (DCNVA)
Outcome measures
| Measure |
Crystalens AO
n=52 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=50 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=46 eyes
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Best-corrected Distance Visual Acuity
DCNVA Monocular Visit 4
|
0.360 logMAR
Standard Deviation 0.144
|
-0.042 logMAR
Standard Deviation 0.132
|
0.136 logMAR
Standard Deviation 0.144
|
|
Best-corrected Distance Visual Acuity
BCDVA Monocular Visit 3
|
-0.100 logMAR
Standard Deviation 0.070
|
-0.094 logMAR
Standard Deviation 0.080
|
-0.068 logMAR
Standard Deviation 0.098
|
|
Best-corrected Distance Visual Acuity
BCDVA Monocular Visit 4
|
-0.100 logMAR
Standard Deviation 0.066
|
-0.096 logMAR
Standard Deviation 0.106
|
-0.075 logMAR
Standard Deviation 0.088
|
|
Best-corrected Distance Visual Acuity
BCDVA Binocular Visit 3
|
-0.144 logMAR
Standard Deviation 0.049
|
-0.133 logMAR
Standard Deviation 0.073
|
0.115 logMAR
Standard Deviation 0.057
|
|
Best-corrected Distance Visual Acuity
BCDVA Binocular Visit 4
|
-0.136 logMAR
Standard Deviation 0.049
|
-0.137 logMAR
Standard Deviation 0.058
|
-0.117 logMAR
Standard Deviation 0.098
|
|
Best-corrected Distance Visual Acuity
DCIVA Monocular Visit 3
|
0.169 logMAR
Standard Deviation 0.144
|
0.292 logMAR
Standard Deviation 0.132
|
0.292 logMAR
Standard Deviation 0.162
|
|
Best-corrected Distance Visual Acuity
DCIVA Monocular Visit 4
|
0.186 logMAR
Standard Deviation 0.129
|
0.297 logMAR
Standard Deviation 0.119
|
0.328 logMAR
Standard Deviation 0.159
|
|
Best-corrected Distance Visual Acuity
DCIVA Binocular Visit 3
|
0.095 logMAR
Standard Deviation 0.146
|
0.222 logMAR
Standard Deviation 0.112
|
0.196 logMAR
Standard Deviation 0.112
|
|
Best-corrected Distance Visual Acuity
DCIVA Binocular Visit 4
|
0.084 logMAR
Standard Deviation 0.109
|
0.229 logMAR
Standard Deviation 0.108
|
0.229 logMAR
Standard Deviation 0.127
|
|
Best-corrected Distance Visual Acuity
DCNVA Monocular Visit 3
|
0.346 logMAR
Standard Deviation 0.130
|
-0.004 logMAR
Standard Deviation 0.087
|
0.132 logMAR
Standard Deviation 0.143
|
|
Best-corrected Distance Visual Acuity
DCNVA Binocular Visit 3
|
0.261 logMAR
Standard Deviation 0.109
|
-0.079 logMAR
Standard Deviation 0.065
|
-0.004 logMAR
Standard Deviation 0.100
|
|
Best-corrected Distance Visual Acuity
DCNVA Binocular Visit 4
|
0.247 logMAR
Standard Deviation 0.126
|
-0.075 logMAR
Standard Deviation 0.096
|
0.025 logMAR
Standard Deviation 0.127
|
Adverse Events
Crystalens AO
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
ReSTOR
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Tecnis Multifocal IOL
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Crystalens AO
n=52 participants at risk；n=26 participants at risk
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=50 participants at risk；n=25 participants at risk
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=46 participants at risk；n=23 participants at risk
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Eye disorders
Vitreous hemorrhage
|
0.00%
0/26 • 6 months
Serious adverse events were measured by participant where as Other adverse events were measured by eye.
|
0.00%
0/25 • 6 months
Serious adverse events were measured by participant where as Other adverse events were measured by eye.
|
4.3%
1/23 • Number of events 1 • 6 months
Serious adverse events were measured by participant where as Other adverse events were measured by eye.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/26 • 6 months
Serious adverse events were measured by participant where as Other adverse events were measured by eye.
|
4.0%
1/25 • Number of events 1 • 6 months
Serious adverse events were measured by participant where as Other adverse events were measured by eye.
|
0.00%
0/23 • 6 months
Serious adverse events were measured by participant where as Other adverse events were measured by eye.
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/26 • 6 months
Serious adverse events were measured by participant where as Other adverse events were measured by eye.
|
0.00%
0/25 • 6 months
Serious adverse events were measured by participant where as Other adverse events were measured by eye.
|
4.3%
1/23 • Number of events 1 • 6 months
Serious adverse events were measured by participant where as Other adverse events were measured by eye.
|
|
Renal and urinary disorders
Pyelonephritis
|
0.00%
0/26 • 6 months
Serious adverse events were measured by participant where as Other adverse events were measured by eye.
|
0.00%
0/25 • 6 months
Serious adverse events were measured by participant where as Other adverse events were measured by eye.
|
4.3%
1/23 • Number of events 1 • 6 months
Serious adverse events were measured by participant where as Other adverse events were measured by eye.
|
Other adverse events
| Measure |
Crystalens AO
n=52 participants at risk；n=26 participants at risk
Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
|
ReSTOR
n=50 participants at risk；n=25 participants at risk
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
|
Tecnis Multifocal IOL
n=46 participants at risk；n=23 participants at risk
Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
|
|---|---|---|---|
|
Eye disorders
Corneal Edema
|
3.8%
2/52 • Number of events 2 • 6 months
Serious adverse events were measured by participant where as Other adverse events were measured by eye.
|
10.0%
5/50 • Number of events 5 • 6 months
Serious adverse events were measured by participant where as Other adverse events were measured by eye.
|
4.3%
2/46 • Number of events 2 • 6 months
Serious adverse events were measured by participant where as Other adverse events were measured by eye.
|
|
Eye disorders
Punctate Keratitis
|
15.4%
8/52 • Number of events 8 • 6 months
Serious adverse events were measured by participant where as Other adverse events were measured by eye.
|
2.0%
1/50 • Number of events 1 • 6 months
Serious adverse events were measured by participant where as Other adverse events were measured by eye.
|
4.3%
2/46 • Number of events 2 • 6 months
Serious adverse events were measured by participant where as Other adverse events were measured by eye.
|
|
Eye disorders
Increased Intraocular Pressure (IOP)
|
0.00%
0/52 • 6 months
Serious adverse events were measured by participant where as Other adverse events were measured by eye.
|
14.0%
7/50 • Number of events 7 • 6 months
Serious adverse events were measured by participant where as Other adverse events were measured by eye.
|
0.00%
0/46 • 6 months
Serious adverse events were measured by participant where as Other adverse events were measured by eye.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER