Trial Outcomes & Findings for Clinical Investigation of the Bi Flex M Multifocal IOL (NCT NCT02338882)
NCT ID: NCT02338882
Last Updated: 2019-09-24
Results Overview
Monocular Visual acuity at 12-18 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
Visit 2 [12-18 months]
Results posted on
2019-09-24
Participant Flow
Participant milestones
| Measure |
Bi Flex M Multifocal Intraocular Lens
Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens
Bi flex M multifocal intraocular lens: Multifocal intraocular lens
|
Bi Flex 1.8 Monofocal Intraocular
Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens
Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
43
|
47
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
Bi Flex M Multifocal Intraocular Lens
Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens
Bi flex M multifocal intraocular lens: Multifocal intraocular lens
|
Bi Flex 1.8 Monofocal Intraocular
Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens
Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
6
|
3
|
Baseline Characteristics
Clinical Investigation of the Bi Flex M Multifocal IOL
Baseline characteristics by cohort
| Measure |
Bi Flex M Monofocal Intraocular Lens
n=50 Participants
Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens
Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens
|
Bi Flex M Multifocal Intraocular Lens
n=50 Participants
Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens
Bi flex M multifocal intraocular lens: Multifocal intraocular lens
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76.7 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
76.6 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
76.6 years
STANDARD_DEVIATION 6.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Pupil Size
|
3.72 Millimeters
STANDARD_DEVIATION 0.53 • n=5 Participants
|
3.75 Millimeters
STANDARD_DEVIATION 0.62 • n=7 Participants
|
3.73 Millimeters
STANDARD_DEVIATION 0.57 • n=5 Participants
|
|
Mean Spherical Equivalent
|
0.09 Dioptres
STANDARD_DEVIATION 2.02 • n=5 Participants
|
-0.44 Dioptres
STANDARD_DEVIATION 2.42 • n=7 Participants
|
-0.17 Dioptres
STANDARD_DEVIATION 2.21 • n=5 Participants
|
|
J0
|
0.61 Dioptres
STANDARD_DEVIATION 0.77 • n=5 Participants
|
0.65 Dioptres
STANDARD_DEVIATION 0.69 • n=7 Participants
|
0.62 Dioptres
STANDARD_DEVIATION .73 • n=5 Participants
|
|
J45
|
0.02 Dioptres
STANDARD_DEVIATION 0.45 • n=5 Participants
|
0.04 Dioptres
STANDARD_DEVIATION 0.50 • n=7 Participants
|
0.03 Dioptres
STANDARD_DEVIATION 0.47 • n=5 Participants
|
|
Pre-operative corrected distance visual acuity
Oculus Dexter (OD)
|
0.32 LogMAR
STANDARD_DEVIATION 0.12 • n=5 Participants
|
0.36 LogMAR
STANDARD_DEVIATION 0.14 • n=7 Participants
|
0.34 LogMAR
STANDARD_DEVIATION 0.13 • n=5 Participants
|
|
Pre-operative corrected distance visual acuity
Oculus Sinister (OS)
|
0.32 LogMAR
STANDARD_DEVIATION 0.13 • n=5 Participants
|
0.36 LogMAR
STANDARD_DEVIATION 0.16 • n=7 Participants
|
0.34 LogMAR
STANDARD_DEVIATION 0.15 • n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 2 [12-18 months]Monocular Visual acuity at 12-18 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR
Outcome measures
| Measure |
Bi Flex 1.8 Monofocal Intraocular
n=47 Participants
Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens
Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens
|
Bi Flex M Multifocal Intraocular Lens
n=43 Participants
Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens
Bi flex M multifocal intraocular lens: Multifocal intraocular lens
|
|---|---|---|
|
Long Term Monocular Visual Acuity (VA)
Monocular Uncorrected Distance VA
|
0.192 LogMAR
Standard Deviation 0.156
|
0.205 LogMAR
Standard Deviation 0.138
|
|
Long Term Monocular Visual Acuity (VA)
Monocular Uncorrected Near VA
|
0.614 LogMAR
Standard Deviation 0.198
|
0.319 LogMAR
Standard Deviation 0.107
|
|
Long Term Monocular Visual Acuity (VA)
Monocular Corrected Distance VA
|
0.070 LogMAR
Standard Deviation 0.105
|
0.093 LogMAR
Standard Deviation 0.090
|
|
Long Term Monocular Visual Acuity (VA)
Monocular Distance Corrected Intermediate VA
|
0.421 LogMAR
Standard Deviation 0.180
|
0.389 LogMAR
Standard Deviation 0.130
|
|
Long Term Monocular Visual Acuity (VA)
Monocular Distance Corrected Near VA
|
0.605 LogMAR
Standard Deviation 0.133
|
0.288 LogMAR
Standard Deviation 0.143
|
PRIMARY outcome
Timeframe: Visit 2 [12-18 months]Binocular Visual acuity at 12-18 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR
Outcome measures
| Measure |
Bi Flex 1.8 Monofocal Intraocular
n=43 Participants
Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens
Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens
|
Bi Flex M Multifocal Intraocular Lens
n=47 Participants
Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens
Bi flex M multifocal intraocular lens: Multifocal intraocular lens
|
|---|---|---|
|
Long Term Binocular Visual Acuity (VA)
Binocular Uncorrected Distance VA
|
0.102 LogMAR
Standard Deviation 0.100
|
0.093 LogMAR
Standard Deviation 0.092
|
|
Long Term Binocular Visual Acuity (VA)
Binocular Uncorrected Near VA
|
0.275 LogMAR
Standard Deviation 0.103
|
0.574 LogMAR
Standard Deviation 0.178
|
|
Long Term Binocular Visual Acuity (VA)
Binocular Corrected Distance VA
|
0.039 LogMAR
Standard Deviation 0.070
|
0.031 LogMAR
Standard Deviation 0.785
|
|
Long Term Binocular Visual Acuity (VA)
Binocular Distance Corrected Intermediate VA
|
0.354 LogMAR
Standard Deviation 0.103
|
0.393 LogMAR
Standard Deviation 0.165
|
|
Long Term Binocular Visual Acuity (VA)
Binocular Distance Corrected Near VA
|
0.241 LogMAR
Standard Deviation 0.100
|
0.571 LogMAR
Standard Deviation 0.137
|
PRIMARY outcome
Timeframe: Visit 1 [3-6 months]Monocular Visual acuity at 3-6 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR
Outcome measures
| Measure |
Bi Flex 1.8 Monofocal Intraocular
n=47 Participants
Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens
Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens
|
Bi Flex M Multifocal Intraocular Lens
n=43 Participants
Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens
Bi flex M multifocal intraocular lens: Multifocal intraocular lens
|
|---|---|---|
|
Monocular Visual Acuity (VA)
Monocular Uncorrected Distance VA
|
0.171 LogMAR
Standard Deviation 0.144
|
0.183 LogMAR
Standard Deviation 0.156
|
|
Monocular Visual Acuity (VA)
Monocular Uncorrected Near VA
|
0.576 LogMAR
Standard Deviation 0.211
|
0.276 LogMAR
Standard Deviation 0.160
|
|
Monocular Visual Acuity (VA)
Monocular Distance Corrected Intermediate VA
|
0.417 LogMAR
Standard Deviation 0.134
|
0.393 LogMAR
Standard Deviation 0.125
|
|
Monocular Visual Acuity (VA)
Monocular Corrected Distance VA
|
0.052 LogMAR
Standard Deviation 0.083
|
0.076 LogMAR
Standard Deviation 0.077
|
|
Monocular Visual Acuity (VA)
Monocular Distance Corrected Near VA
|
0.571 LogMAR
Standard Deviation 0.180
|
0.271 LogMAR
Standard Deviation 0.132
|
PRIMARY outcome
Timeframe: Visit 1 [3-6 months]Binocular Visual acuity at 3-6 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR
Outcome measures
| Measure |
Bi Flex 1.8 Monofocal Intraocular
n=47 Participants
Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens
Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens
|
Bi Flex M Multifocal Intraocular Lens
n=43 Participants
Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens
Bi flex M multifocal intraocular lens: Multifocal intraocular lens
|
|---|---|---|
|
Binocular Visual Acuity (VA)
Binocular Uncorrected Distance VA
|
0.085 LogMAR
Standard Deviation 0.105
|
0.101 LogMAR
Standard Deviation 0.085
|
|
Binocular Visual Acuity (VA)
Binocular Uncorrected Near VA
|
0.554 LogMAR
Standard Deviation 0.197
|
0.231 LogMAR
Standard Deviation 0.125
|
|
Binocular Visual Acuity (VA)
Binocular Corrected Distance VA
|
0.012 LogMAR
Standard Deviation 0.072
|
0.044 LogMAR
Standard Deviation 0.064
|
|
Binocular Visual Acuity (VA)
Binocular Distance Corrected Intermediate VA
|
0.391 LogMAR
Standard Deviation 0.128
|
0.378 LogMAR
Standard Deviation 0.132
|
|
Binocular Visual Acuity (VA)
Binocular Distance Corrected Near VA
|
0.535 LogMAR
Standard Deviation 0.170
|
0.236 LogMAR
Standard Deviation 0.131
|
PRIMARY outcome
Timeframe: visit 1 (3-6 months)Visual acuity measurement (assessed in LogMAR) taken with differing levels of optical defocus
Outcome measures
| Measure |
Bi Flex 1.8 Monofocal Intraocular
n=47 Participants
Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens
Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens
|
Bi Flex M Multifocal Intraocular Lens
n=43 Participants
Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens
Bi flex M multifocal intraocular lens: Multifocal intraocular lens
|
|---|---|---|
|
Defocus Curve Profiles
+1.50
|
0.376 LogMAR
Standard Deviation 0.145
|
0.429 LogMAR
Standard Deviation 0.139
|
|
Defocus Curve Profiles
+1.00
|
0.218 LogMAR
Standard Deviation 0.093
|
0.300 LogMAR
Standard Deviation 0.285
|
|
Defocus Curve Profiles
+0.50
|
0.089 LogMAR
Standard Deviation 0.071
|
0.124 LogMAR
Standard Deviation 0.078
|
|
Defocus Curve Profiles
0.00
|
0.017 LogMAR
Standard Deviation 0.072
|
0.050 LogMAR
Standard Deviation 0.078
|
|
Defocus Curve Profiles
-0.50
|
0.104 LogMAR
Standard Deviation 0.090
|
0.135 LogMAR
Standard Deviation 0.078
|
|
Defocus Curve Profiles
-1.00
|
0.253 LogMAR
Standard Deviation 0.147
|
0.287 LogMAR
Standard Deviation 0.101
|
|
Defocus Curve Profiles
-1.50
|
0.369 LogMAR
Standard Deviation 0.167
|
0.328 LogMAR
Standard Deviation 0.116
|
|
Defocus Curve Profiles
-2.00
|
0.505 LogMAR
Standard Deviation 0.174
|
0.256 LogMAR
Standard Deviation 0.132
|
|
Defocus Curve Profiles
-2.50
|
0.611 LogMAR
Standard Deviation 0.181
|
0.201 LogMAR
Standard Deviation 0.180
|
|
Defocus Curve Profiles
-3.00
|
0.700 LogMAR
Standard Deviation 0.169
|
0.235 LogMAR
Standard Deviation 0.164
|
|
Defocus Curve Profiles
-3.50
|
0.745 LogMAR
Standard Deviation 0.153
|
0.366 LogMAR
Standard Deviation 0.187
|
|
Defocus Curve Profiles
-4.00
|
0.805 LogMAR
Standard Deviation 0.122
|
0.515 LogMAR
Standard Deviation 0.149
|
|
Defocus Curve Profiles
-4.50
|
0.848 LogMAR
Standard Deviation 0.113
|
0.610 LogMAR
Standard Deviation 0.124
|
|
Defocus Curve Profiles
-5.00
|
0.893 LogMAR
Standard Deviation 0.123
|
0.743 LogMAR
Standard Deviation 0.122
|
PRIMARY outcome
Timeframe: visit 2 (12-18 months)Assessed as a dioptric range and using the Defocus area metric
Outcome measures
| Measure |
Bi Flex 1.8 Monofocal Intraocular
n=47 Participants
Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens
Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens
|
Bi Flex M Multifocal Intraocular Lens
n=43 Participants
Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens
Bi flex M multifocal intraocular lens: Multifocal intraocular lens
|
|---|---|---|
|
Long Term Defocus Curve Profiles
1.50
|
0.377 LogMAR
Standard Deviation 0.150
|
0.359 LogMAR
Standard Deviation 0.100
|
|
Long Term Defocus Curve Profiles
1.00
|
0.225 LogMAR
Standard Deviation 0.126
|
0.223 LogMAR
Standard Deviation 0.089
|
|
Long Term Defocus Curve Profiles
0.50
|
0.093 LogMAR
Standard Deviation 0.084
|
0.108 LogMAR
Standard Deviation 0.067
|
|
Long Term Defocus Curve Profiles
0.00
|
0.029 LogMAR
Standard Deviation 0.082
|
0.043 LogMAR
Standard Deviation 0.073
|
|
Long Term Defocus Curve Profiles
-0.50
|
0.111 LogMAR
Standard Deviation 0.010
|
0.128 LogMAR
Standard Deviation 0.077
|
|
Long Term Defocus Curve Profiles
-1.00
|
0.244 LogMAR
Standard Deviation 0.121
|
0.259 LogMAR
Standard Deviation 0.085
|
|
Long Term Defocus Curve Profiles
-1.50
|
0.349 LogMAR
Standard Deviation 0.159
|
0.309 LogMAR
Standard Deviation 0.151
|
|
Long Term Defocus Curve Profiles
-2.00
|
0.499 LogMAR
Standard Deviation 0.170
|
0.196 LogMAR
Standard Deviation 0.141
|
|
Long Term Defocus Curve Profiles
-2.50
|
0.596 LogMAR
Standard Deviation 0.186
|
0.155 LogMAR
Standard Deviation 0.113
|
|
Long Term Defocus Curve Profiles
-3.00
|
0.647 LogMAR
Standard Deviation 0.171
|
0.188 LogMAR
Standard Deviation 0.107
|
|
Long Term Defocus Curve Profiles
-3.50
|
0.692 LogMAR
Standard Deviation 0.166
|
0.312 LogMAR
Standard Deviation 0.111
|
|
Long Term Defocus Curve Profiles
-4.00
|
0.748 LogMAR
Standard Deviation 0.146
|
0.454 LogMAR
Standard Deviation 0.118
|
|
Long Term Defocus Curve Profiles
-4.50
|
0.778 LogMAR
Standard Deviation 0.127
|
0.563 LogMAR
Standard Deviation 0.116
|
|
Long Term Defocus Curve Profiles
-5.00
|
0.804 LogMAR
Standard Deviation 0.100
|
0.673 LogMAR
Standard Deviation 0.095
|
SECONDARY outcome
Timeframe: Visit 2 [12-18 months]MonocularContrast sensitivity assessed as a contrast threshold using the Pelli-Robson test
Outcome measures
| Measure |
Bi Flex 1.8 Monofocal Intraocular
n=47 Participants
Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens
Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens
|
Bi Flex M Multifocal Intraocular Lens
n=43 Participants
Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens
Bi flex M multifocal intraocular lens: Multifocal intraocular lens
|
|---|---|---|
|
Long Term Monocular Pelli-Robson Contrast Sensitivity (CS)
|
1.347 Log CS
Standard Deviation 0.154
|
1.259 Log CS
Standard Deviation 0.150
|
SECONDARY outcome
Timeframe: Visit 2 [12-18 month]Binocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test
Outcome measures
| Measure |
Bi Flex 1.8 Monofocal Intraocular
n=47 Participants
Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens
Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens
|
Bi Flex M Multifocal Intraocular Lens
n=43 Participants
Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens
Bi flex M multifocal intraocular lens: Multifocal intraocular lens
|
|---|---|---|
|
Long Term Binocular Pelli-Robson Contrast Sensitivity (CS)
|
1.434 Log CS
Standard Deviation 0.136
|
1.379 Log CS
Standard Deviation 0.131
|
SECONDARY outcome
Timeframe: Visit 1 [3-6 months]Monocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test
Outcome measures
| Measure |
Bi Flex 1.8 Monofocal Intraocular
n=48 Participants
Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens
Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens
|
Bi Flex M Multifocal Intraocular Lens
n=46 Participants
Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens
Bi flex M multifocal intraocular lens: Multifocal intraocular lens
|
|---|---|---|
|
Pelli-Robson Monocular Contrast Sensitivity
|
1.428 Log CS
Standard Deviation 0.124
|
1.309 Log CS
Standard Deviation 0.156
|
SECONDARY outcome
Timeframe: Visit 1 [3-6 months]Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test
Outcome measures
| Measure |
Bi Flex 1.8 Monofocal Intraocular
n=48 Participants
Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens
Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens
|
Bi Flex M Multifocal Intraocular Lens
n=46 Participants
Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens
Bi flex M multifocal intraocular lens: Multifocal intraocular lens
|
|---|---|---|
|
Pelli-Robson Binocular Contrast Sensitivity
|
1.506 Log CS
Standard Deviation 0.088
|
1.391 Log CS
Standard Deviation 0.131
|
SECONDARY outcome
Timeframe: Visit 2 [12-18 months]Binocular Assessment of Contrast Sensitivity at threshold using the Contrast sensitivity vision(CSV) CSV-1000
Outcome measures
| Measure |
Bi Flex 1.8 Monofocal Intraocular
n=47 Participants
Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens
Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens
|
Bi Flex M Multifocal Intraocular Lens
n=43 Participants
Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens
Bi flex M multifocal intraocular lens: Multifocal intraocular lens
|
|---|---|---|
|
Long Term Contrast Sensitivity CSV-1000
3 cycles per degree (cpd)
|
1.558 Log CS
Standard Deviation 0.162
|
1.515 Log CS
Standard Deviation 0.172
|
|
Long Term Contrast Sensitivity CSV-1000
6cpd
|
1.704 Log CS
Standard Deviation 0.200
|
1.636 Log CS
Standard Deviation 0.161
|
|
Long Term Contrast Sensitivity CSV-1000
12cpd
|
1.379 Log CS
Standard Deviation 0.219
|
1.258 Log CS
Standard Deviation 0.249
|
|
Long Term Contrast Sensitivity CSV-1000
18cpd
|
0.911 Log CS
Standard Deviation 0.216
|
0.765 Log CS
Standard Deviation 0.230
|
SECONDARY outcome
Timeframe: Visit 1 [3-6 months]Binocular Assessment of Contrast Sensitivity at threshold using the CSV-1000
Outcome measures
| Measure |
Bi Flex 1.8 Monofocal Intraocular
n=48 Participants
Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens
Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens
|
Bi Flex M Multifocal Intraocular Lens
n=46 Participants
Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens
Bi flex M multifocal intraocular lens: Multifocal intraocular lens
|
|---|---|---|
|
Contrast Sensitivity CSV-1000
3cpd
|
1.569 Log CS
Standard Deviation 0.175
|
1.471 Log CS
Standard Deviation 0.180
|
|
Contrast Sensitivity CSV-1000
6cpd
|
1.771 Log CS
Standard Deviation 0.213
|
1.624 Log CS
Standard Deviation 0.152
|
|
Contrast Sensitivity CSV-1000
12cpd
|
1.417 Log CS
Standard Deviation 0.261
|
1.249 Log CS
Standard Deviation 0.260
|
|
Contrast Sensitivity CSV-1000
18cpd
|
0.942 Log CS
Standard Deviation 0.162
|
0.828 Log CS
Standard Deviation 0.261
|
SECONDARY outcome
Timeframe: Visit 2 (12-18 months)Assessed as the critical print size and using the reading performance index. Uses Radner reading chart and logarithmic Radner scale (LogRAD) Lower LogRAD equals smaller print size
Outcome measures
| Measure |
Bi Flex 1.8 Monofocal Intraocular
n=47 Participants
Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens
Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens
|
Bi Flex M Multifocal Intraocular Lens
n=43 Participants
Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens
Bi flex M multifocal intraocular lens: Multifocal intraocular lens
|
|---|---|---|
|
Long Term Reading Performance
|
0.948 LogRAD
Standard Deviation 0.428
|
0.604 LogRAD
Standard Deviation 0.307
|
SECONDARY outcome
Timeframe: visit 1 (3-6 months)Assessed as the critical print size and using the reading performance index Logarithmic Radner scale (LogRAD) Lower LogRAD equals small print size
Outcome measures
| Measure |
Bi Flex 1.8 Monofocal Intraocular
n=47 Participants
Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens
Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens
|
Bi Flex M Multifocal Intraocular Lens
n=43 Participants
Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens
Bi flex M multifocal intraocular lens: Multifocal intraocular lens
|
|---|---|---|
|
Reading Performance
|
0.837 LogRAD
Standard Deviation 0.297
|
0.692 LogRAD
Standard Deviation 0.534
|
SECONDARY outcome
Timeframe: Visit 2 (12-18 months)Assessed as the glare area size Scale 0 to 100 Higher scores = larger glare area =worse outcome
Outcome measures
| Measure |
Bi Flex 1.8 Monofocal Intraocular
n=47 Participants
Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens
Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens
|
Bi Flex M Multifocal Intraocular Lens
n=43 Participants
Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens
Bi flex M multifocal intraocular lens: Multifocal intraocular lens
|
|---|---|---|
|
Long Term Glare
|
3.78 units on a scale
Standard Deviation 14.2
|
37.4 units on a scale
Standard Deviation 26.6
|
SECONDARY outcome
Timeframe: visit 1 (3-6 months)Population: Scale 0 to 100 Higher score = larger glare area = worse outcome
Assessed as the glare area size Scale 0 to 100 Higher score = larger area = worse outcome
Outcome measures
| Measure |
Bi Flex 1.8 Monofocal Intraocular
n=47 Participants
Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens
Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens
|
Bi Flex M Multifocal Intraocular Lens
n=43 Participants
Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens
Bi flex M multifocal intraocular lens: Multifocal intraocular lens
|
|---|---|---|
|
Glare
|
4.4 units on a scale
Standard Deviation 16.5
|
41.7 units on a scale
Standard Deviation 29.4
|
Adverse Events
Bi Flex 1.8 Monofocal Intraocular
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bi Flex M Multifocal Intraocular Lens
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place