Clinical Investigation of the Bi Flex M Multifocal IOL

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Bi flex M multifocal intraocular lens; Device: Bi flex 1.8 monofocal intraocular lens

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long Term Monocular Pelli-Robson Contrast Sensitivity (CS)	MonocularContrast sensitivity assessed as a contrast threshold using the Pelli-Robson test	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	Visit 2 [12-18 month]
Pelli-Robson Monocular Contrast Sensitivity	Monocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test	Visit 1 [3-6 months]
Pelli-Robson Binocular Contrast Sensitivity	Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test	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	Visit 2 [12-18 months]
Contrast Sensitivity CSV-1000	Binocular Assessment of Contrast Sensitivity at threshold using the CSV-1000	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	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	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	Visit 2 (12-18 months)
Glare	Assessed as the glare area size Scale 0 to 100 Higher score = larger area = worse outcome	visit 1 (3-6 months)

Collaborators and Investigators

• Sponsor: Dr Phillip J Buckhurst
• Collaborators: BMI Southend Hospital
• Investigators: Principal Investigator: Phillip J Buckhurst, PhD, Plymouth University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: January 7, 2015
• First Submitted That Met QC Criteria: January 13, 2015
• First Posted (Estimate): January 14, 2015

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 4, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Intraocular; Lenses
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: MC001