CataractPhase 4NCT02338882

Clinical Investigation of the Bi Flex M Multifocal IOL

A Phase 4 study testing Bi flex M multifocal intraocular lens and Bi flex 1.8 monofocal intraocular lens in people with Cataract, run by Dr Phillip J Buckhurst.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cataract
What is being tested?: Bi flex M multifocal intraocular lens and Bi flex 1.8 monofocal intraocular lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: No sites listed yet
Study dates: Sep 2015to 31 May 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 18Show fewer

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

About this study

Official title: Randomised Clinical Investigation of the Bi Flex M Multifocal Intraocular Lens

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.

Conditions: Cataract
Being tested: Bi flex M multifocal intraocular lens, Bi flex 1.8 monofocal intraocular lens
Keywords: Lenses, Intraocular
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bi flex M multifocal intraocular lensDevice
Multifocal intraocular lens
Bi flex 1.8 monofocal intraocular lensDevice
Standard monofocal intraocular lens

Study groups in NCT02338882
Study group	Role	What they receive
Bi flex M multifocal intraocular lens	Experimental	Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Receives: Device: Bi flex M multifocal intraocular lens
Bi flex 1.8 monofocal intraocular	Active comparator	Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens Receives: Device: Bi flex 1.8 monofocal intraocular lens

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Visit 2 [12-18 months]
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
Measured: Visit 2 [12-18 months]
Monocular Visual Acuity (VA)
Monocular Visual acuity at 3-6 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR
Measured: Visit 1 [3-6 months]
Binocular Visual Acuity (VA)
Binocular Visual acuity at 3-6 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR
Measured: Visit 1 [3-6 months]
Defocus Curve Profiles
Visual acuity measurement (assessed in LogMAR) taken with differing levels of optical defocus
Measured: visit 1 (3-6 months)
Long Term Defocus Curve Profiles
Assessed as a dioptric range and using the Defocus area metric
Measured: visit 2 (12-18 months)

Secondary outcomes (10)

Long Term Monocular Pelli-Robson Contrast Sensitivity (CS)
MonocularContrast sensitivity assessed as a contrast threshold using the Pelli-Robson test
Measured: Visit 2 [12-18 months]
Long Term Binocular Pelli-Robson Contrast Sensitivity (CS)
Binocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test
Measured: Visit 2 [12-18 month]
Pelli-Robson Monocular Contrast Sensitivity
Monocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test
Measured: Visit 1 [3-6 months]
Pelli-Robson Binocular Contrast Sensitivity
Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test
Measured: Visit 1 [3-6 months]
Long Term Contrast Sensitivity CSV-1000
Binocular Assessment of Contrast Sensitivity at threshold using the Contrast sensitivity vision(CSV) CSV-1000
Measured: Visit 2 [12-18 months]
Contrast Sensitivity CSV-1000
Binocular Assessment of Contrast Sensitivity at threshold using the CSV-1000
Measured: Visit 1 [3-6 months]
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
Measured: Visit 2 (12-18 months)
Reading Performance
Assessed as the critical print size and using the reading performance index Logarithmic Radner scale (LogRAD) Lower LogRAD equals small print size
Measured: visit 1 (3-6 months)
Long Term Glare
Assessed as the glare area size Scale 0 to 100 Higher scores = larger glare area =worse outcome
Measured: Visit 2 (12-18 months)
Glare
Assessed as the glare area size Scale 0 to 100 Higher score = larger area = worse outcome
Measured: visit 1 (3-6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201531 May 2019

First posted14 Jan 2015 (estimated)
Study startSep 2015
Primary completionDec 2018
Study completion31 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CataractStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02338882
Sponsor's protocol ID: MC001
Status last verified: Sep 2019
First submitted: 7 Jan 2015
Last updated: 24 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
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Age-Related Eye Disease Study (AREDS) Follow-Up
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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomised Clinical Investigation of the Bi Flex M Multifocal Intraocular Lens
ClinicalTrials.gov ID: NCT02338882
Acronym / sponsor ID: MC001
Conditions: Cataract
Keywords: Lenses, Intraocular
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Dr Phillip J BuckhurstUniversity, hospital or other
Collaborators: BMI Southend Hospital
Study start: Sep 2015 (actual)
Primary completion: Dec 2018 (actual)
Study completion: 31 May 2019 (actual)
First posted: 14 Jan 2015 (estimated)
Results: Posted 24 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Bi flex M multifocal intraocular lens	Experimental	Device: Bi flex M multifocal intraocular lensSubjects implanted bilaterally with the Bi flex M multifocal intraocular lens
Bi flex 1.8 monofocal intraocular	Active comparator	Device: Bi flex 1.8 monofocal intraocular lensSubjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (18 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bi flex M multifocal intraocular lensMultifocal intraocular lens	Device	Bi flex M multifocal intraocular lens
Bi flex 1.8 monofocal intraocular lensStandard monofocal intraocular lens	Device	Bi flex 1.8 monofocal intraocular

Primary outcome

Long Term Monocular Visual Acuity (VA)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: visit 1 (3-6 months)
Visual acuity measurement (assessed in LogMAR) taken with differing levels of optical defocus
Long Term Defocus Curve Profiles
Time frame: visit 2 (12-18 months)
Assessed as a dioptric range and using the Defocus area metric

10 secondary outcomes

Long Term Monocular Pelli-Robson Contrast Sensitivity (CS)
Time frame: Visit 2 [12-18 months]
Long Term Binocular Pelli-Robson Contrast Sensitivity (CS)
Time frame: Visit 2 [12-18 month]
Pelli-Robson Monocular Contrast Sensitivity
Time frame: Visit 1 [3-6 months]
Pelli-Robson Binocular Contrast Sensitivity
Time frame: Visit 1 [3-6 months]
Long Term Contrast Sensitivity CSV-1000
Time frame: Visit 2 [12-18 months]
Contrast Sensitivity CSV-1000
Time frame: Visit 1 [3-6 months]
Long Term Reading Performance
Time frame: Visit 2 (12-18 months)
Reading Performance
Time frame: visit 1 (3-6 months)
Long Term Glare
Time frame: Visit 2 (12-18 months)
Glare
Time frame: visit 1 (3-6 months)

Results and safety

Results posted to the registry on 24 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bi Flex M Multifocal Intraocular Lens	50	43
Bi Flex 1.8 Monofocal Intraocular	50	47

Primary outcome: Long Term Monocular Visual Acuity (VA)

Time frame: Visit 2 [12-18 months]. Mean (Standard Deviation). Unit: LogMAR

Measure	Bi Flex 1.8 Monofocal Intraocular n = 47	Bi Flex M Multifocal Intraocular Lens n = 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)

Primary outcome: Long Term Binocular Visual Acuity (VA)

Time frame: Visit 2 [12-18 months]. Mean (Standard Deviation). Unit: LogMAR

Measure	Bi Flex M Multifocal Intraocular Lens n = 43	Bi Flex 1.8 Monofocal Intraocular n = 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)

Primary outcome: Monocular Visual Acuity (VA)

Time frame: Visit 1 [3-6 months]. Mean (Standard Deviation). Unit: LogMAR

Measure	Bi Flex 1.8 Monofocal Intraocular n = 47	Bi Flex M Multifocal Intraocular Lens n = 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)

Primary outcome: Binocular Visual Acuity (VA)

Time frame: Visit 1 [3-6 months]. Mean (Standard Deviation). Unit: LogMAR

Measure	Bi Flex 1.8 Monofocal Intraocular n = 47	Bi Flex M Multifocal Intraocular Lens n = 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)

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data collected for 18 months post surgery. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bi Flex 1.8 Monofocal Intraocular	0 of 50 (0%)	0 of 50 (0%)	0 of 50
Bi Flex M Multifocal Intraocular Lens	0 of 50 (0%)	0 of 50 (0%)	1 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cataract

Recruiting
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Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Phillip J Buckhurst, PhD principal investigator

Plymouth University

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bi flex M multifocal intraocular lens and Bi flex 1.8 monofocal intraocular lens in people with Cataract, run by Dr Phillip J Buckhurst.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Long Term Monocular Visual Acuity (VA) (time frame: Visit 2 [12-18 months]). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02338882.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.