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Clinical Investigation of the Bi Flex M Multifocal IOL

Primary Purpose

Cataract

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bi flex M multifocal intraocular lens
Bi flex 1.8 monofocal intraocular lens
Sponsored by
Dr Phillip J Buckhurst
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Lenses, Intraocular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Bi flex M multifocal intraocular lens

    Bi flex 1.8 monofocal intraocular

    Arm Description

    Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens

    Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    January 7, 2015
    Last Updated
    September 4, 2019
    Sponsor
    Dr Phillip J Buckhurst
    Collaborators
    BMI Southend Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02338882
    Brief Title
    Clinical Investigation of the Bi Flex M Multifocal IOL
    Official Title
    Randomised Clinical Investigation of the Bi Flex M Multifocal Intraocular Lens
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2015 (Actual)
    Primary Completion Date
    December 2018 (Actual)
    Study Completion Date
    May 31, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dr Phillip J Buckhurst
    Collaborators
    BMI Southend Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract
    Keywords
    Lenses, Intraocular

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bi flex M multifocal intraocular lens
    Arm Type
    Experimental
    Arm Description
    Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens
    Arm Title
    Bi flex 1.8 monofocal intraocular
    Arm Type
    Active Comparator
    Arm Description
    Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens
    Intervention Type
    Device
    Intervention Name(s)
    Bi flex M multifocal intraocular lens
    Intervention Description
    Multifocal intraocular lens
    Intervention Type
    Device
    Intervention Name(s)
    Bi flex 1.8 monofocal intraocular lens
    Intervention Description
    Standard monofocal intraocular lens
    Primary Outcome Measure Information:
    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]
    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]
    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]
    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]
    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)
    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)
    Secondary Outcome Measure Information:
    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]
    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]
    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]
    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]
    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]
    Title
    Contrast Sensitivity CSV-1000
    Description
    Binocular Assessment of Contrast Sensitivity at threshold using the CSV-1000
    Time Frame
    Visit 1 [3-6 months]
    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)
    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)
    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)
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Phillip J Buckhurst, PhD
    Organizational Affiliation
    Plymouth University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Investigation of the Bi Flex M Multifocal IOL

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