CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
Bi flex M multifocal intraocular lens +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02338882
NCT02338882Phase 4Completed

Randomised Clinical Investigation of the Bi Flex M Multifocal Intraocular Lens

Dr Phillip J Buckhurst·interventional·Posted Jan 14, 2015·Updated Sep 24, 2019

In Brief

A Phase 4 clinical trial evaluating Bi flex M multifocal intraocular lens and Bi flex 1.8 monofocal intraocular lens for Cataract. Completed, enrolled 100 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCataract
Countries--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 14, 2015
Enrollment StartSep 1, 2015
Primary CompletionDec 1, 2018
Study CompletionMay 31, 2019
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 11.5 years ago

Interventions

Bi flex M multifocal intraocular lensdevice

Multifocal intraocular lens

Bi flex 1.8 monofocal intraocular lensdevice

Standard monofocal intraocular lens