Clinical Investigation of the Bi Flex M Multifocal IOL

NCT02338882 | Completed Phase 4 Results

• 1 other identifier: MC001
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract

Keywords

Lenses; Intraocular

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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

  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

  Visit 1 [3-6 months]

• Defocus Curve Profiles

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

  visit 1 (3-6 months)

• Long Term Defocus Curve Profiles

  Assessed as a dioptric range and using the Defocus area metric

  visit 2 (12-18 months)

Secondary Outcomes (10)

• Long Term Monocular Pelli-Robson Contrast Sensitivity (CS)

  Visit 2 [12-18 months]

• Long Term Binocular Pelli-Robson Contrast Sensitivity (CS)

  Visit 2 [12-18 month]

• Pelli-Robson Monocular Contrast Sensitivity

  Visit 1 [3-6 months]

• Pelli-Robson Binocular Contrast Sensitivity

  Visit 1 [3-6 months]

• Long Term Contrast Sensitivity CSV-1000

  Visit 2 [12-18 months]

Study Arms (2)

Bi flex M multifocal intraocular lens

EXPERIMENTAL

Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens

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

Device: Bi flex 1.8 monofocal intraocular lens

Interventions

Bi flex M multifocal intraocular lens DEVICE

Multifocal intraocular lens

Bi flex M multifocal intraocular lens

Bi flex 1.8 monofocal intraocular lens DEVICE

Standard monofocal intraocular lens

Bi flex 1.8 monofocal intraocular

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Phillip J Buckhurst: lead
• BMI Southend Hospital: collaborator

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Dr Phillip Buckhurst
• Organization: University of Plymouth

phillip.buckhurst@plymouth.ac.uk

01752 588884

Study Officials

• Phillip J Buckhurst, PhD

  Plymouth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor (Senior Lecturer)

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 14, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: May 31, 2019
• Last Updated: September 24, 2019
• Results First Posted: September 24, 2019

Record last verified: 2019-09