Cataract
Conditions
Keywords
Lenses, Intraocular
Brief summary
During cataract surgery an artificial lens is implanted in the eye. These artificial lenses are called intraocular lenses (IOLs) and there are many different types of IOL designs. IOLs are of fixed focus and so unless a multifocal IOL is used you would need to wear spectacles for viewing near objects. This study has been designed to look at how well a multifocal IOL corrects distance and near vision in comparison with a conventional monofocal IOL. Both types of IOLs are commercially available and are commonly implanted. Using new non-invasive methods we hope to be able to better judge the visual performance of these IOLs. In addition the study will involve imaging and examining the IOLs to determine the prevalence of any post-operative complications.
Interventions
DEVICEBi flex M multifocal intraocular lens
Multifocal intraocular lens
DEVICEBi flex 1.8 monofocal intraocular lens
Standard monofocal intraocular lens
Sponsors
BMI Southend Hospital
Dr Phillip J Buckhurst
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age related cataract patients requiring cataract surgery with phacoemulsification. * Patients requiring primary IOL implantation * Patients with a potential corrected visual acuity of 20/40 or better on clinical assessment * Patients with normal anterior segments apart from cataracts * Subjects with clear intraocular media other than cataract
Exclusion criteria
* Preexisting pathology or physiology, which may be aggravated by the implant, or may render the implant ineffective and that could potentially cause future acuity losses to a level of 0.5 or 20/40 or worse in either eye. This includes the following: * Microphthalmia * Corneal decompensation or Endothelial Insufficiency * Pseudo exfoliation * High myopia * Pars planitis * Patient with greater than 1 dioptre of preoperative corneal astigmatism * Subjects who are expected to require retinal laser treatment * Previous intraocular and/or corneal surgery * History of uveitis, glaucoma, proliferative diabetic retinopathy, pseudoexfoliation, macular degeneration that may affect potential best corrected visual acuity of 20/40 or better * Operative complications of posterior capsular rupture, zonular dehiscence, incomplete continuous curvilinear capsulorhexis, severe iris /corneal trauma and inability to achieve secure placement in the designated location * Subjects using a systemic medication that is known to cause ocular side effects * Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days * Subjects who have only one eye with potentially good vision * Patients who are not willing to cooperate for the follow up period * Visual eccentricity of greater than 0.7mm * Pregnant women * Patients where it is not possible to take informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long Term Monocular Visual Acuity (VA) | 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 |
| Long Term Binocular Visual Acuity (VA) | 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 |
| Monocular Visual Acuity (VA) | 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 |
| Binocular Visual Acuity (VA) | 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 |
| Defocus Curve Profiles | visit 1 (3-6 months) | Visual acuity measurement (assessed in LogMAR) taken with differing levels of optical defocus |
| Long Term Defocus Curve Profiles | visit 2 (12-18 months) | Assessed as a dioptric range and using the Defocus area metric |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long Term Reading Performance | 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 |
| Reading Performance | 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 |
| Long Term Monocular Pelli-Robson Contrast Sensitivity (CS) | Visit 2 [12-18 months] | MonocularContrast sensitivity assessed as a contrast threshold using the Pelli-Robson test |
| Glare | visit 1 (3-6 months) | Assessed as the glare area size Scale 0 to 100 Higher score = larger area = worse outcome |
| Long Term Glare | Visit 2 (12-18 months) | Assessed as the glare area size Scale 0 to 100 Higher scores = larger glare area =worse outcome |
| Long Term Binocular Pelli-Robson Contrast Sensitivity (CS) | Visit 2 [12-18 month] | Binocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test |
| Pelli-Robson Monocular Contrast Sensitivity | Visit 1 [3-6 months] | Monocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test |
| Pelli-Robson Binocular Contrast Sensitivity | Visit 1 [3-6 months] | Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test |
| Long Term Contrast Sensitivity CSV-1000 | Visit 2 [12-18 months] | Binocular Assessment of Contrast Sensitivity at threshold using the Contrast sensitivity vision(CSV) CSV-1000 |
| Contrast Sensitivity CSV-1000 | Visit 1 [3-6 months] | Binocular Assessment of Contrast Sensitivity at threshold using the CSV-1000 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bi Flex M Monofocal Intraocular Lens Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens
Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens | 50 |
| 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 | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 6 | 3 |
Baseline characteristics
| Characteristic | Bi Flex M Monofocal Intraocular Lens | Total | Bi Flex M Multifocal Intraocular Lens |
|---|---|---|---|
| Age, Continuous | 76.7 years STANDARD_DEVIATION 6.4 | 76.6 years STANDARD_DEVIATION 6.34 | 76.6 years STANDARD_DEVIATION 6.1 |
| J0 | 0.61 Dioptres STANDARD_DEVIATION 0.77 | 0.62 Dioptres STANDARD_DEVIATION 0.73 | 0.65 Dioptres STANDARD_DEVIATION 0.69 |
| J45 | 0.02 Dioptres STANDARD_DEVIATION 0.45 | 0.03 Dioptres STANDARD_DEVIATION 0.47 | 0.04 Dioptres STANDARD_DEVIATION 0.5 |
| Mean Spherical Equivalent | 0.09 Dioptres STANDARD_DEVIATION 2.02 | -0.17 Dioptres STANDARD_DEVIATION 2.21 | -0.44 Dioptres STANDARD_DEVIATION 2.42 |
| Pre-operative corrected distance visual acuity Oculus Dexter (OD) | 0.32 LogMAR STANDARD_DEVIATION 0.12 | 0.34 LogMAR STANDARD_DEVIATION 0.13 | 0.36 LogMAR STANDARD_DEVIATION 0.14 |
| Pre-operative corrected distance visual acuity Oculus Sinister (OS) | 0.32 LogMAR STANDARD_DEVIATION 0.13 | 0.34 LogMAR STANDARD_DEVIATION 0.15 | 0.36 LogMAR STANDARD_DEVIATION 0.16 |
| Pupil Size | 3.72 Millimeters STANDARD_DEVIATION 0.53 | 3.73 Millimeters STANDARD_DEVIATION 0.57 | 3.75 Millimeters STANDARD_DEVIATION 0.62 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 50 Participants | 100 Participants | 50 Participants |
| Region of Enrollment United Kingdom | 50 participants | 100 participants | 50 participants |
| Sex: Female, Male Female | 32 Participants | 71 Participants | 39 Participants |
| Sex: Female, Male Male | 18 Participants | 29 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 1 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Binocular Visual Acuity (VA)
Binocular Visual acuity at 3-6 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR
Time frame: Visit 1 [3-6 months]
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bi Flex 1.8 Monofocal Intraocular | Binocular Visual Acuity (VA) | Binocular Uncorrected Near VA | 0.554 LogMAR | Standard Deviation 0.197 |
| Bi Flex 1.8 Monofocal Intraocular | Binocular Visual Acuity (VA) | Binocular Distance Corrected Intermediate VA | 0.391 LogMAR | Standard Deviation 0.128 |
| Bi Flex 1.8 Monofocal Intraocular | Binocular Visual Acuity (VA) | Binocular Corrected Distance VA | 0.012 LogMAR | Standard Deviation 0.072 |
| Bi Flex 1.8 Monofocal Intraocular | Binocular Visual Acuity (VA) | Binocular Distance Corrected Near VA | 0.535 LogMAR | Standard Deviation 0.17 |
| Bi Flex 1.8 Monofocal Intraocular | Binocular Visual Acuity (VA) | Binocular Uncorrected Distance VA | 0.085 LogMAR | Standard Deviation 0.105 |
| Bi Flex M Multifocal Intraocular Lens | Binocular Visual Acuity (VA) | Binocular Distance Corrected Near VA | 0.236 LogMAR | Standard Deviation 0.131 |
| Bi Flex M Multifocal Intraocular Lens | Binocular Visual Acuity (VA) | Binocular Uncorrected Distance VA | 0.101 LogMAR | Standard Deviation 0.085 |
| Bi Flex M Multifocal Intraocular Lens | Binocular Visual Acuity (VA) | Binocular Uncorrected Near VA | 0.231 LogMAR | Standard Deviation 0.125 |
| Bi Flex M Multifocal Intraocular Lens | Binocular Visual Acuity (VA) | Binocular Corrected Distance VA | 0.044 LogMAR | Standard Deviation 0.064 |
| Bi Flex M Multifocal Intraocular Lens | Binocular Visual Acuity (VA) | Binocular Distance Corrected Intermediate VA | 0.378 LogMAR | Standard Deviation 0.132 |
Primary
Defocus Curve Profiles
Visual acuity measurement (assessed in LogMAR) taken with differing levels of optical defocus
Time frame: visit 1 (3-6 months)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bi Flex 1.8 Monofocal Intraocular | Defocus Curve Profiles | -2.00 | 0.505 LogMAR | Standard Deviation 0.174 |
| Bi Flex 1.8 Monofocal Intraocular | Defocus Curve Profiles | -0.50 | 0.104 LogMAR | Standard Deviation 0.09 |
| Bi Flex 1.8 Monofocal Intraocular | Defocus Curve Profiles | -2.50 | 0.611 LogMAR | Standard Deviation 0.181 |
| Bi Flex 1.8 Monofocal Intraocular | Defocus Curve Profiles | 0.00 | 0.017 LogMAR | Standard Deviation 0.072 |
| Bi Flex 1.8 Monofocal Intraocular | Defocus Curve Profiles | -3.00 | 0.700 LogMAR | Standard Deviation 0.169 |
| Bi Flex 1.8 Monofocal Intraocular | Defocus Curve Profiles | +1.00 | 0.218 LogMAR | Standard Deviation 0.093 |
| Bi Flex 1.8 Monofocal Intraocular | Defocus Curve Profiles | -3.50 | 0.745 LogMAR | Standard Deviation 0.153 |
| Bi Flex 1.8 Monofocal Intraocular | Defocus Curve Profiles | -1.00 | 0.253 LogMAR | Standard Deviation 0.147 |
| Bi Flex 1.8 Monofocal Intraocular | Defocus Curve Profiles | -4.00 | 0.805 LogMAR | Standard Deviation 0.122 |
| Bi Flex 1.8 Monofocal Intraocular | Defocus Curve Profiles | +1.50 | 0.376 LogMAR | Standard Deviation 0.145 |
| Bi Flex 1.8 Monofocal Intraocular | Defocus Curve Profiles | -4.50 | 0.848 LogMAR | Standard Deviation 0.113 |
| Bi Flex 1.8 Monofocal Intraocular | Defocus Curve Profiles | -1.50 | 0.369 LogMAR | Standard Deviation 0.167 |
| Bi Flex 1.8 Monofocal Intraocular | Defocus Curve Profiles | -5.00 | 0.893 LogMAR | Standard Deviation 0.123 |
| Bi Flex 1.8 Monofocal Intraocular | Defocus Curve Profiles | +0.50 | 0.089 LogMAR | Standard Deviation 0.071 |
| Bi Flex M Multifocal Intraocular Lens | Defocus Curve Profiles | -5.00 | 0.743 LogMAR | Standard Deviation 0.122 |
| Bi Flex M Multifocal Intraocular Lens | Defocus Curve Profiles | +1.50 | 0.429 LogMAR | Standard Deviation 0.139 |
| Bi Flex M Multifocal Intraocular Lens | Defocus Curve Profiles | +1.00 | 0.300 LogMAR | Standard Deviation 0.285 |
| Bi Flex M Multifocal Intraocular Lens | Defocus Curve Profiles | +0.50 | 0.124 LogMAR | Standard Deviation 0.078 |
| Bi Flex M Multifocal Intraocular Lens | Defocus Curve Profiles | -0.50 | 0.135 LogMAR | Standard Deviation 0.078 |
| Bi Flex M Multifocal Intraocular Lens | Defocus Curve Profiles | -1.00 | 0.287 LogMAR | Standard Deviation 0.101 |
| Bi Flex M Multifocal Intraocular Lens | Defocus Curve Profiles | -1.50 | 0.328 LogMAR | Standard Deviation 0.116 |
| Bi Flex M Multifocal Intraocular Lens | Defocus Curve Profiles | -2.00 | 0.256 LogMAR | Standard Deviation 0.132 |
| Bi Flex M Multifocal Intraocular Lens | Defocus Curve Profiles | -2.50 | 0.201 LogMAR | Standard Deviation 0.18 |
| Bi Flex M Multifocal Intraocular Lens | Defocus Curve Profiles | -3.00 | 0.235 LogMAR | Standard Deviation 0.164 |
| Bi Flex M Multifocal Intraocular Lens | Defocus Curve Profiles | -3.50 | 0.366 LogMAR | Standard Deviation 0.187 |
| Bi Flex M Multifocal Intraocular Lens | Defocus Curve Profiles | -4.00 | 0.515 LogMAR | Standard Deviation 0.149 |
| Bi Flex M Multifocal Intraocular Lens | Defocus Curve Profiles | -4.50 | 0.610 LogMAR | Standard Deviation 0.124 |
| Bi Flex M Multifocal Intraocular Lens | Defocus Curve Profiles | 0.00 | 0.050 LogMAR | Standard Deviation 0.078 |
Primary
Long Term Binocular Visual Acuity (VA)
Binocular Visual acuity at 12-18 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR
Time frame: Visit 2 [12-18 months]
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bi Flex 1.8 Monofocal Intraocular | Long Term Binocular Visual Acuity (VA) | Binocular Uncorrected Near VA | 0.275 LogMAR | Standard Deviation 0.103 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Binocular Visual Acuity (VA) | Binocular Distance Corrected Intermediate VA | 0.354 LogMAR | Standard Deviation 0.103 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Binocular Visual Acuity (VA) | Binocular Corrected Distance VA | 0.039 LogMAR | Standard Deviation 0.07 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Binocular Visual Acuity (VA) | Binocular Distance Corrected Near VA | 0.241 LogMAR | Standard Deviation 0.1 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Binocular Visual Acuity (VA) | Binocular Uncorrected Distance VA | 0.102 LogMAR | Standard Deviation 0.1 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Binocular Visual Acuity (VA) | Binocular Distance Corrected Near VA | 0.571 LogMAR | Standard Deviation 0.137 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Binocular Visual Acuity (VA) | Binocular Uncorrected Distance VA | 0.093 LogMAR | Standard Deviation 0.092 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Binocular Visual Acuity (VA) | Binocular Uncorrected Near VA | 0.574 LogMAR | Standard Deviation 0.178 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Binocular Visual Acuity (VA) | Binocular Corrected Distance VA | 0.031 LogMAR | Standard Deviation 0.785 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Binocular Visual Acuity (VA) | Binocular Distance Corrected Intermediate VA | 0.393 LogMAR | Standard Deviation 0.165 |
Primary
Long Term Defocus Curve Profiles
Assessed as a dioptric range and using the Defocus area metric
Time frame: visit 2 (12-18 months)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bi Flex 1.8 Monofocal Intraocular | Long Term Defocus Curve Profiles | 0.50 | 0.093 LogMAR | Standard Deviation 0.084 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Defocus Curve Profiles | -3.50 | 0.692 LogMAR | Standard Deviation 0.166 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Defocus Curve Profiles | 0.00 | 0.029 LogMAR | Standard Deviation 0.082 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Defocus Curve Profiles | -2.00 | 0.499 LogMAR | Standard Deviation 0.17 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Defocus Curve Profiles | -0.50 | 0.111 LogMAR | Standard Deviation 0.01 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Defocus Curve Profiles | -1.50 | 0.349 LogMAR | Standard Deviation 0.159 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Defocus Curve Profiles | -1.00 | 0.244 LogMAR | Standard Deviation 0.121 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Defocus Curve Profiles | 1.50 | 0.377 LogMAR | Standard Deviation 0.15 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Defocus Curve Profiles | -4.00 | 0.748 LogMAR | Standard Deviation 0.146 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Defocus Curve Profiles | -3.00 | 0.647 LogMAR | Standard Deviation 0.171 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Defocus Curve Profiles | -4.50 | 0.778 LogMAR | Standard Deviation 0.127 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Defocus Curve Profiles | 1.00 | 0.225 LogMAR | Standard Deviation 0.126 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Defocus Curve Profiles | -5.00 | 0.804 LogMAR | Standard Deviation 0.1 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Defocus Curve Profiles | -2.50 | 0.596 LogMAR | Standard Deviation 0.186 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Defocus Curve Profiles | -5.00 | 0.673 LogMAR | Standard Deviation 0.095 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Defocus Curve Profiles | -2.00 | 0.196 LogMAR | Standard Deviation 0.141 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Defocus Curve Profiles | -2.50 | 0.155 LogMAR | Standard Deviation 0.113 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Defocus Curve Profiles | -3.00 | 0.188 LogMAR | Standard Deviation 0.107 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Defocus Curve Profiles | -3.50 | 0.312 LogMAR | Standard Deviation 0.111 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Defocus Curve Profiles | 1.50 | 0.359 LogMAR | Standard Deviation 0.1 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Defocus Curve Profiles | 1.00 | 0.223 LogMAR | Standard Deviation 0.089 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Defocus Curve Profiles | 0.50 | 0.108 LogMAR | Standard Deviation 0.067 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Defocus Curve Profiles | 0.00 | 0.043 LogMAR | Standard Deviation 0.073 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Defocus Curve Profiles | -0.50 | 0.128 LogMAR | Standard Deviation 0.077 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Defocus Curve Profiles | -1.00 | 0.259 LogMAR | Standard Deviation 0.085 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Defocus Curve Profiles | -4.00 | 0.454 LogMAR | Standard Deviation 0.118 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Defocus Curve Profiles | -4.50 | 0.563 LogMAR | Standard Deviation 0.116 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Defocus Curve Profiles | -1.50 | 0.309 LogMAR | Standard Deviation 0.151 |
Primary
Long Term Monocular Visual Acuity (VA)
Monocular Visual acuity at 12-18 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR
Time frame: Visit 2 [12-18 months]
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bi Flex 1.8 Monofocal Intraocular | Long Term Monocular Visual Acuity (VA) | Monocular Uncorrected Near VA | 0.614 LogMAR | Standard Deviation 0.198 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Monocular Visual Acuity (VA) | Monocular Distance Corrected Intermediate VA | 0.421 LogMAR | Standard Deviation 0.18 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Monocular Visual Acuity (VA) | Monocular Corrected Distance VA | 0.070 LogMAR | Standard Deviation 0.105 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Monocular Visual Acuity (VA) | Monocular Distance Corrected Near VA | 0.605 LogMAR | Standard Deviation 0.133 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Monocular Visual Acuity (VA) | Monocular Uncorrected Distance VA | 0.192 LogMAR | Standard Deviation 0.156 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Monocular Visual Acuity (VA) | Monocular Distance Corrected Near VA | 0.288 LogMAR | Standard Deviation 0.143 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Monocular Visual Acuity (VA) | Monocular Uncorrected Distance VA | 0.205 LogMAR | Standard Deviation 0.138 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Monocular Visual Acuity (VA) | Monocular Uncorrected Near VA | 0.319 LogMAR | Standard Deviation 0.107 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Monocular Visual Acuity (VA) | Monocular Corrected Distance VA | 0.093 LogMAR | Standard Deviation 0.09 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Monocular Visual Acuity (VA) | Monocular Distance Corrected Intermediate VA | 0.389 LogMAR | Standard Deviation 0.13 |
Primary
Monocular Visual Acuity (VA)
Monocular Visual acuity at 3-6 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR
Time frame: Visit 1 [3-6 months]
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bi Flex 1.8 Monofocal Intraocular | Monocular Visual Acuity (VA) | Monocular Uncorrected Near VA | 0.576 LogMAR | Standard Deviation 0.211 |
| Bi Flex 1.8 Monofocal Intraocular | Monocular Visual Acuity (VA) | Monocular Distance Corrected Intermediate VA | 0.417 LogMAR | Standard Deviation 0.134 |
| Bi Flex 1.8 Monofocal Intraocular | Monocular Visual Acuity (VA) | Monocular Corrected Distance VA | 0.052 LogMAR | Standard Deviation 0.083 |
| Bi Flex 1.8 Monofocal Intraocular | Monocular Visual Acuity (VA) | Monocular Distance Corrected Near VA | 0.571 LogMAR | Standard Deviation 0.18 |
| Bi Flex 1.8 Monofocal Intraocular | Monocular Visual Acuity (VA) | Monocular Uncorrected Distance VA | 0.171 LogMAR | Standard Deviation 0.144 |
| Bi Flex M Multifocal Intraocular Lens | Monocular Visual Acuity (VA) | Monocular Distance Corrected Near VA | 0.271 LogMAR | Standard Deviation 0.132 |
| Bi Flex M Multifocal Intraocular Lens | Monocular Visual Acuity (VA) | Monocular Uncorrected Distance VA | 0.183 LogMAR | Standard Deviation 0.156 |
| Bi Flex M Multifocal Intraocular Lens | Monocular Visual Acuity (VA) | Monocular Uncorrected Near VA | 0.276 LogMAR | Standard Deviation 0.16 |
| Bi Flex M Multifocal Intraocular Lens | Monocular Visual Acuity (VA) | Monocular Corrected Distance VA | 0.076 LogMAR | Standard Deviation 0.077 |
| Bi Flex M Multifocal Intraocular Lens | Monocular Visual Acuity (VA) | Monocular Distance Corrected Intermediate VA | 0.393 LogMAR | Standard Deviation 0.125 |
Secondary
Contrast Sensitivity CSV-1000
Binocular Assessment of Contrast Sensitivity at threshold using the CSV-1000
Time frame: Visit 1 [3-6 months]
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bi Flex 1.8 Monofocal Intraocular | Contrast Sensitivity CSV-1000 | 3cpd | 1.569 Log CS | Standard Deviation 0.175 |
| Bi Flex 1.8 Monofocal Intraocular | Contrast Sensitivity CSV-1000 | 6cpd | 1.771 Log CS | Standard Deviation 0.213 |
| Bi Flex 1.8 Monofocal Intraocular | Contrast Sensitivity CSV-1000 | 12cpd | 1.417 Log CS | Standard Deviation 0.261 |
| Bi Flex 1.8 Monofocal Intraocular | Contrast Sensitivity CSV-1000 | 18cpd | 0.942 Log CS | Standard Deviation 0.162 |
| Bi Flex M Multifocal Intraocular Lens | Contrast Sensitivity CSV-1000 | 18cpd | 0.828 Log CS | Standard Deviation 0.261 |
| Bi Flex M Multifocal Intraocular Lens | Contrast Sensitivity CSV-1000 | 3cpd | 1.471 Log CS | Standard Deviation 0.18 |
| Bi Flex M Multifocal Intraocular Lens | Contrast Sensitivity CSV-1000 | 12cpd | 1.249 Log CS | Standard Deviation 0.26 |
| Bi Flex M Multifocal Intraocular Lens | Contrast Sensitivity CSV-1000 | 6cpd | 1.624 Log CS | Standard Deviation 0.152 |
Secondary
Glare
Assessed as the glare area size Scale 0 to 100 Higher score = larger area = worse outcome
Time frame: visit 1 (3-6 months)
Population: Scale 0 to 100 Higher score = larger glare area = worse outcome
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bi Flex 1.8 Monofocal Intraocular | Glare | 4.4 units on a scale | Standard Deviation 16.5 |
| Bi Flex M Multifocal Intraocular Lens | Glare | 41.7 units on a scale | Standard Deviation 29.4 |
Secondary
Long Term Binocular Pelli-Robson Contrast Sensitivity (CS)
Binocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test
Time frame: Visit 2 [12-18 month]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bi Flex 1.8 Monofocal Intraocular | Long Term Binocular Pelli-Robson Contrast Sensitivity (CS) | 1.434 Log CS | Standard Deviation 0.136 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Binocular Pelli-Robson Contrast Sensitivity (CS) | 1.379 Log CS | Standard Deviation 0.131 |
Secondary
Long Term Contrast Sensitivity CSV-1000
Binocular Assessment of Contrast Sensitivity at threshold using the Contrast sensitivity vision(CSV) CSV-1000
Time frame: Visit 2 [12-18 months]
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bi Flex 1.8 Monofocal Intraocular | Long Term Contrast Sensitivity CSV-1000 | 3 cycles per degree (cpd) | 1.558 Log CS | Standard Deviation 0.162 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Contrast Sensitivity CSV-1000 | 6cpd | 1.704 Log CS | Standard Deviation 0.2 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Contrast Sensitivity CSV-1000 | 12cpd | 1.379 Log CS | Standard Deviation 0.219 |
| Bi Flex 1.8 Monofocal Intraocular | Long Term Contrast Sensitivity CSV-1000 | 18cpd | 0.911 Log CS | Standard Deviation 0.216 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Contrast Sensitivity CSV-1000 | 18cpd | 0.765 Log CS | Standard Deviation 0.23 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Contrast Sensitivity CSV-1000 | 3 cycles per degree (cpd) | 1.515 Log CS | Standard Deviation 0.172 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Contrast Sensitivity CSV-1000 | 12cpd | 1.258 Log CS | Standard Deviation 0.249 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Contrast Sensitivity CSV-1000 | 6cpd | 1.636 Log CS | Standard Deviation 0.161 |
Secondary
Long Term Glare
Assessed as the glare area size Scale 0 to 100 Higher scores = larger glare area =worse outcome
Time frame: Visit 2 (12-18 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bi Flex 1.8 Monofocal Intraocular | Long Term Glare | 3.78 units on a scale | Standard Deviation 14.2 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Glare | 37.4 units on a scale | Standard Deviation 26.6 |
Secondary
Long Term Monocular Pelli-Robson Contrast Sensitivity (CS)
MonocularContrast sensitivity assessed as a contrast threshold using the Pelli-Robson test
Time frame: Visit 2 [12-18 months]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bi Flex 1.8 Monofocal Intraocular | Long Term Monocular Pelli-Robson Contrast Sensitivity (CS) | 1.347 Log CS | Standard Deviation 0.154 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Monocular Pelli-Robson Contrast Sensitivity (CS) | 1.259 Log CS | Standard Deviation 0.15 |
Secondary
Long Term Reading Performance
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
Time frame: Visit 2 (12-18 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bi Flex 1.8 Monofocal Intraocular | Long Term Reading Performance | 0.948 LogRAD | Standard Deviation 0.428 |
| Bi Flex M Multifocal Intraocular Lens | Long Term Reading Performance | 0.604 LogRAD | Standard Deviation 0.307 |
Secondary
Pelli-Robson Binocular Contrast Sensitivity
Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test
Time frame: Visit 1 [3-6 months]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bi Flex 1.8 Monofocal Intraocular | Pelli-Robson Binocular Contrast Sensitivity | 1.506 Log CS | Standard Deviation 0.088 |
| Bi Flex M Multifocal Intraocular Lens | Pelli-Robson Binocular Contrast Sensitivity | 1.391 Log CS | Standard Deviation 0.131 |
Secondary
Pelli-Robson Monocular Contrast Sensitivity
Monocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test
Time frame: Visit 1 [3-6 months]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bi Flex 1.8 Monofocal Intraocular | Pelli-Robson Monocular Contrast Sensitivity | 1.428 Log CS | Standard Deviation 0.124 |
| Bi Flex M Multifocal Intraocular Lens | Pelli-Robson Monocular Contrast Sensitivity | 1.309 Log CS | Standard Deviation 0.156 |
Secondary
Reading Performance
Assessed as the critical print size and using the reading performance index Logarithmic Radner scale (LogRAD) Lower LogRAD equals small print size
Time frame: visit 1 (3-6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bi Flex 1.8 Monofocal Intraocular | Reading Performance | 0.837 LogRAD | Standard Deviation 0.297 |
| Bi Flex M Multifocal Intraocular Lens | Reading Performance | 0.692 LogRAD | Standard Deviation 0.534 |