Clinical Investigation of the Bi Flex M Multifocal IOL

• Sponsor: Dr Phillip J Buckhurst (Other)
• Overall Status: Completed
• CT.gov ID: NCT02338882
• Collaborator: BMI Southend Hospital (Other)
• Enrollment: 100
• Arms: 2
• Actual Duration (Months): 44.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: Bi flex M multifocal intraocular lens; Device: Bi flex 1.8 monofocal intraocular lens	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomised Clinical Investigation of the Bi Flex M Multifocal Intraocular Lens
• Actual Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: May 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bi flex M multifocal intraocular lens Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens	Device: Bi flex M multifocal intraocular lens; Multifocal intraocular lens
Active Comparator: Bi flex 1.8 monofocal intraocular Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens	Device: Bi flex 1.8 monofocal intraocular lens; Standard monofocal intraocular lens

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. Defocus Curve Profiles [visit 1 (3-6 months)]

   Visual acuity measurement (assessed in LogMAR) taken with differing levels of optical defocus

6. Long Term Defocus Curve Profiles [visit 2 (12-18 months)]

   Assessed as a dioptric range and using the Defocus area metric

Secondary Outcome Measures

1. 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

2. 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

3. Pelli-Robson Monocular Contrast Sensitivity [Visit 1 [3-6 months]]

   Monocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test

4. Pelli-Robson Binocular Contrast Sensitivity [Visit 1 [3-6 months]]

   Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test

5. 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

6. Contrast Sensitivity CSV-1000 [Visit 1 [3-6 months]]

   Binocular Assessment of Contrast Sensitivity at threshold using the CSV-1000

7. 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

8. 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

9. 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

10. Glare [visit 1 (3-6 months)]

    Assessed as the glare area size Scale 0 to 100 Higher score = larger area = worse outcome

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Dr Phillip J Buckhurst
• BMI Southend Hospital

Investigators

• Principal Investigator: Phillip J Buckhurst, PhD, Plymouth University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 23, 2015

More Information

Publications

None provided.

• Responsible Party: Dr Phillip J Buckhurst, Associate Professor (Senior Lecturer), University of Plymouth
• ClinicalTrials.gov Identifier: NCT02338882
• Other Study ID Numbers: MC001
• First Posted: Jan 14, 2015
• Last Update Posted: Sep 24, 2019
• Last Verified: Sep 1, 2019

• Keywords provided by Dr Phillip J Buckhurst, Associate Professor (Senior Lecturer), University of Plymouth: Lenses; Intraocular
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Arm/Group Title	Bi Flex M Multifocal Intraocular Lens	Bi Flex 1.8 Monofocal Intraocular
Arm/Group Description	Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Bi flex M multifocal intraocular lens: Multifocal 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
Period Title: Overall Study
STARTED	50	50
COMPLETED	43	47
NOT COMPLETED	7	3

Baseline Characteristics

Arm/Group Title	Bi Flex M Monofocal Intraocular Lens	Bi Flex M Multifocal Intraocular Lens	Total
Arm/Group Description	Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens	Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Bi flex M multifocal intraocular lens: Multifocal intraocular lens	Total of all reporting groups
Overall Participants	50	50	100
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	76.7 (6.4)	76.6 (6.1)	76.6 (6.34)
Sex: Female, Male (Count of Participants)
Female	32 64%	39 78%	71 71%
Male	18 36%	11 22%	29 29%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	50 100%	50 100%	100 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United Kingdom	50 100%	50 100%	100 100%
Pupil Size (Millimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Millimeters]	3.72 (0.53)	3.75 (0.62)	3.73 (0.57)
Mean Spherical Equivalent (Dioptres) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Dioptres]	0.09 (2.02)	-0.44 (2.42)	-0.17 (2.21)
J0 (Dioptres) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Dioptres]	0.61 (0.77)	0.65 (0.69)	0.62 (.73)
J45 (Dioptres) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Dioptres]	0.02 (0.45)	0.04 (0.50)	0.03 (0.47)
Pre-operative corrected distance visual acuity (LogMAR) [Mean (Standard Deviation) ]
Oculus Dexter (OD)	0.32 (0.12)	0.36 (0.14)	0.34 (0.13)
Oculus Sinister (OS)	0.32 (0.13)	0.36 (0.16)	0.34 (0.15)

Outcome Measures

1. Primary Outcome

Title	Long Term Monocular Visual Acuity (VA)
Description	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]

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bi Flex 1.8 Monofocal Intraocular	Bi Flex M Multifocal Intraocular Lens
Arm/Group Description	Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens	Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Bi flex M multifocal intraocular lens: Multifocal intraocular lens
Measure Participants	47	43
Monocular Uncorrected Distance VA	0.192 (0.156)	0.205 (0.138)
Monocular Uncorrected Near VA	0.614 (0.198)	0.319 (0.107)
Monocular Corrected Distance VA	0.070 (0.105)	0.093 (0.090)
Monocular Distance Corrected Intermediate VA	0.421 (0.180)	0.389 (0.130)
Monocular Distance Corrected Near VA	0.605 (0.133)	0.288 (0.143)

2. Primary Outcome

Title	Long Term Binocular Visual Acuity (VA)
Description	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]

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bi Flex M Multifocal Intraocular Lens	Bi Flex 1.8 Monofocal Intraocular
Arm/Group Description	Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Bi flex M multifocal intraocular lens: Multifocal 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
Measure Participants	43	47
Binocular Uncorrected Distance VA	0.102 (0.100)	0.093 (0.092)
Binocular Uncorrected Near VA	0.275 (0.103)	0.574 (0.178)
Binocular Corrected Distance VA	0.039 (0.070)	0.031 (0.785)
Binocular Distance Corrected Intermediate VA	0.354 (0.103)	0.393 (0.165)
Binocular Distance Corrected Near VA	0.241 (0.100)	0.571 (0.137)

3. Primary Outcome

Title	Monocular Visual Acuity (VA)
Description	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]

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bi Flex 1.8 Monofocal Intraocular	Bi Flex M Multifocal Intraocular Lens
Arm/Group Description	Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens	Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Bi flex M multifocal intraocular lens: Multifocal intraocular lens
Measure Participants	47	43
Monocular Uncorrected Distance VA	0.171 (0.144)	0.183 (0.156)
Monocular Uncorrected Near VA	0.576 (0.211)	0.276 (0.160)
Monocular Corrected Distance VA	0.052 (0.083)	0.076 (0.077)
Monocular Distance Corrected Intermediate VA	0.417 (0.134)	0.393 (0.125)
Monocular Distance Corrected Near VA	0.571 (0.180)	0.271 (0.132)

4. Primary Outcome

Title	Binocular Visual Acuity (VA)
Description	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]

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bi Flex 1.8 Monofocal Intraocular	Bi Flex M Multifocal Intraocular Lens
Arm/Group Description	Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens	Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Bi flex M multifocal intraocular lens: Multifocal intraocular lens
Measure Participants	47	43
Binocular Uncorrected Distance VA	0.085 (0.105)	0.101 (0.085)
Binocular Uncorrected Near VA	0.554 (0.197)	0.231 (0.125)
Binocular Corrected Distance VA	0.012 (0.072)	0.044 (0.064)
Binocular Distance Corrected Intermediate VA	0.391 (0.128)	0.378 (0.132)
Binocular Distance Corrected Near VA	0.535 (0.170)	0.236 (0.131)

5. Primary Outcome

Title	Defocus Curve Profiles
Description	Visual acuity measurement (assessed in LogMAR) taken with differing levels of optical defocus
Time Frame	visit 1 (3-6 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bi Flex 1.8 Monofocal Intraocular	Bi Flex M Multifocal Intraocular Lens
Arm/Group Description	Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens	Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Bi flex M multifocal intraocular lens: Multifocal intraocular lens
Measure Participants	47	43
+1.50	0.376 (0.145)	0.429 (0.139)
+1.00	0.218 (0.093)	0.300 (0.285)
+0.50	0.089 (0.071)	0.124 (0.078)
0.00	0.017 (0.072)	0.050 (0.078)
-0.50	0.104 (0.090)	0.135 (0.078)
-1.00	0.253 (0.147)	0.287 (0.101)
-1.50	0.369 (0.167)	0.328 (0.116)
-2.00	0.505 (0.174)	0.256 (0.132)
-2.50	0.611 (0.181)	0.201 (0.180)
-3.00	0.700 (0.169)	0.235 (0.164)
-3.50	0.745 (0.153)	0.366 (0.187)
-4.00	0.805 (0.122)	0.515 (0.149)
-4.50	0.848 (0.113)	0.610 (0.124)
-5.00	0.893 (0.123)	0.743 (0.122)

6. Primary Outcome

Title	Long Term Defocus Curve Profiles
Description	Assessed as a dioptric range and using the Defocus area metric
Time Frame	visit 2 (12-18 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bi Flex 1.8 Monofocal Intraocular	Bi Flex M Multifocal Intraocular Lens
Arm/Group Description	Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens	Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Bi flex M multifocal intraocular lens: Multifocal intraocular lens
Measure Participants	47	43
1.50	0.377 (0.150)	0.359 (0.100)
1.00	0.225 (0.126)	0.223 (0.089)
0.50	0.093 (0.084)	0.108 (0.067)
0.00	0.029 (0.082)	0.043 (0.073)
-0.50	0.111 (0.010)	0.128 (0.077)
-1.00	0.244 (0.121)	0.259 (0.085)
-1.50	0.349 (0.159)	0.309 (0.151)
-2.00	0.499 (0.170)	0.196 (0.141)
-2.50	0.596 (0.186)	0.155 (0.113)
-3.00	0.647 (0.171)	0.188 (0.107)
-3.50	0.692 (0.166)	0.312 (0.111)
-4.00	0.748 (0.146)	0.454 (0.118)
-4.50	0.778 (0.127)	0.563 (0.116)
-5.00	0.804 (0.100)	0.673 (0.095)

7. Secondary Outcome

Title	Long Term Monocular Pelli-Robson Contrast Sensitivity (CS)
Description	MonocularContrast sensitivity assessed as a contrast threshold using the Pelli-Robson test
Time Frame	Visit 2 [12-18 months]

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bi Flex 1.8 Monofocal Intraocular	Bi Flex M Multifocal Intraocular Lens
Arm/Group Description	Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens	Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Bi flex M multifocal intraocular lens: Multifocal intraocular lens
Measure Participants	47	43
Mean (Standard Deviation) [Log CS]	1.347 (0.154)	1.259 (0.150)

8. Secondary Outcome

Title	Long Term Binocular Pelli-Robson Contrast Sensitivity (CS)
Description	Binocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test
Time Frame	Visit 2 [12-18 month]

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bi Flex 1.8 Monofocal Intraocular	Bi Flex M Multifocal Intraocular Lens
Arm/Group Description	Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens	Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Bi flex M multifocal intraocular lens: Multifocal intraocular lens
Measure Participants	47	43
Mean (Standard Deviation) [Log CS]	1.434 (0.136)	1.379 (0.131)

9. Secondary Outcome

Title	Pelli-Robson Monocular Contrast Sensitivity
Description	Monocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test
Time Frame	Visit 1 [3-6 months]

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bi Flex 1.8 Monofocal Intraocular	Bi Flex M Multifocal Intraocular Lens
Arm/Group Description	Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens	Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Bi flex M multifocal intraocular lens: Multifocal intraocular lens
Measure Participants	48	46
Mean (Standard Deviation) [Log CS]	1.428 (0.124)	1.309 (0.156)

10. Secondary Outcome

Title	Pelli-Robson Binocular Contrast Sensitivity
Description	Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test
Time Frame	Visit 1 [3-6 months]

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bi Flex 1.8 Monofocal Intraocular	Bi Flex M Multifocal Intraocular Lens
Arm/Group Description	Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens	Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Bi flex M multifocal intraocular lens: Multifocal intraocular lens
Measure Participants	48	46
Mean (Standard Deviation) [Log CS]	1.506 (0.088)	1.391 (0.131)

11. Secondary Outcome

Title	Long Term Contrast Sensitivity CSV-1000
Description	Binocular Assessment of Contrast Sensitivity at threshold using the Contrast sensitivity vision(CSV) CSV-1000
Time Frame	Visit 2 [12-18 months]

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bi Flex 1.8 Monofocal Intraocular	Bi Flex M Multifocal Intraocular Lens
Arm/Group Description	Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens	Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Bi flex M multifocal intraocular lens: Multifocal intraocular lens
Measure Participants	47	43
3 cycles per degree (cpd)	1.558 (0.162)	1.515 (0.172)
6cpd	1.704 (0.200)	1.636 (0.161)
12cpd	1.379 (0.219)	1.258 (0.249)
18cpd	0.911 (0.216)	0.765 (0.230)

12. Secondary Outcome

Title	Contrast Sensitivity CSV-1000
Description	Binocular Assessment of Contrast Sensitivity at threshold using the CSV-1000
Time Frame	Visit 1 [3-6 months]

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bi Flex 1.8 Monofocal Intraocular	Bi Flex M Multifocal Intraocular Lens
Arm/Group Description	Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens	Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Bi flex M multifocal intraocular lens: Multifocal intraocular lens
Measure Participants	48	46
3cpd	1.569 (0.175)	1.471 (0.180)
6cpd	1.771 (0.213)	1.624 (0.152)
12cpd	1.417 (0.261)	1.249 (0.260)
18cpd	0.942 (0.162)	0.828 (0.261)

13. Secondary Outcome

Title	Long Term Reading Performance
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bi Flex 1.8 Monofocal Intraocular	Bi Flex M Multifocal Intraocular Lens
Arm/Group Description	Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens	Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Bi flex M multifocal intraocular lens: Multifocal intraocular lens
Measure Participants	47	43
Mean (Standard Deviation) [LogRAD]	0.948 (0.428)	0.604 (0.307)

14. Secondary Outcome

Title	Reading Performance
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bi Flex 1.8 Monofocal Intraocular	Bi Flex M Multifocal Intraocular Lens
Arm/Group Description	Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens	Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Bi flex M multifocal intraocular lens: Multifocal intraocular lens
Measure Participants	47	43
Mean (Standard Deviation) [LogRAD]	0.837 (0.297)	0.692 (0.534)

15. Secondary Outcome

Title	Long Term Glare
Description	Assessed as the glare area size Scale 0 to 100 Higher scores = larger glare area =worse outcome
Time Frame	Visit 2 (12-18 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bi Flex M Monofocal Intraocular Lens	Bi Flex M Multifocal Intraocular Lens
Arm/Group Description	Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens	Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Bi flex M multifocal intraocular lens: Multifocal intraocular lens
Measure Participants	47	43
Mean (Standard Deviation) [units on a scale]	3.78 (14.2)	37.4 (26.6)

16. Secondary Outcome

Title	Glare
Description	Assessed as the glare area size Scale 0 to 100 Higher score = larger area = worse outcome
Time Frame	visit 1 (3-6 months)

Outcome Measure Data

Analysis Population Description

Scale 0 to 100 Higher score = larger glare area = worse outcome

Arm/Group Title	Bi Flex M Monofocal Intraocular Lens	Bi Flex M Multifocal Intraocular Lens
Arm/Group Description	Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens	Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Bi flex M multifocal intraocular lens: Multifocal intraocular lens
Measure Participants	47	43
Mean (Standard Deviation) [units on a scale]	4.4 (16.5)	41.7 (29.4)

Adverse Events

Time Frame	Data collected for 18 months post surgery
Arm/Group Title	Bi Flex 1.8 Monofocal Intraocular		Bi Flex M Multifocal Intraocular Lens
Arm/Group Description	Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens		Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Bi flex M multifocal intraocular lens: Multifocal intraocular lens
All Cause Mortality
	Bi Flex 1.8 Monofocal Intraocular		Bi Flex M Multifocal Intraocular Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		1/50 (2%)
Serious Adverse Events
	Bi Flex 1.8 Monofocal Intraocular		Bi Flex M Multifocal Intraocular Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Bi Flex 1.8 Monofocal Intraocular		Bi Flex M Multifocal Intraocular Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.