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OpenTrials
Completed

NCT Number: NCT02338882

Clinical Investigation of the Bi Flex M Multifocal IOL

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bi flex M multifocal intraocular lens

Device

Multifocal intraocular lens

Bi flex 1.8 monofocal intraocular lens

Device

Standard monofocal intraocular lens

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Defocus Curve Profiles

    Time frame: visit 1 (3-6 months)

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

  6. Long Term Defocus Curve Profiles

    Time frame: visit 2 (12-18 months)

    Assessed as a dioptric range and using the Defocus area metric

Secondary outcomes

  1. Long Term Monocular Pelli-Robson Contrast Sensitivity (CS)

    Time frame: 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)

    Time frame: Visit 2 [12-18 month]

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

  3. Pelli-Robson Monocular Contrast Sensitivity

    Time frame: Visit 1 [3-6 months]

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

  4. Pelli-Robson Binocular Contrast Sensitivity

    Time frame: Visit 1 [3-6 months]

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

  5. Long Term Contrast Sensitivity CSV-1000

    Time frame: 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

    Time frame: Visit 1 [3-6 months]

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

  7. Long Term Reading Performance

    Time frame: 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

    Time frame: 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

    Time frame: Visit 2 (12-18 months)

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

  10. Glare

    Time frame: visit 1 (3-6 months)

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

Sponsors and collaborators

Lead sponsor

Dr Phillip J Buckhurst

Other

Collaborators

  • BMI Southend Hospital

Registry information

Official study title

Randomised Clinical Investigation of the Bi Flex M Multifocal Intraocular Lens

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jan 14, 2015
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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