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Clinical Investigation of the Bi Flex M Multifocal IOL

NCT02338882 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-09-24

Study results available
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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

Interventions

DEVICE

Bi flex M multifocal intraocular lens

Multifocal intraocular lens

DEVICE

Bi flex 1.8 monofocal intraocular lens

Standard monofocal intraocular lens

Sponsors & Collaborators

  • BMI Southend Hospital

    collaborator OTHER

  • Dr Phillip J Buckhurst

    lead OTHER

Principal Investigators

  • Phillip J Buckhurst, PhD · Plymouth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-12-31
Completion
2019-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02338882 on ClinicalTrials.gov