Randomised clinical investigation of the Bi flex M multifocal IOL
Research type
Research Study
Full title
Randomised clinical trial of the Biflex M multifocal intraocular lens
IRAS ID
165928
Contact name
Phillip Buckhurst
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 10 months, 3 days
Research summary
Artificial lenses, otherwise known as intraocular lenses (IOLs), are used to replace the natural crystalline lens within the eye during cataract or refractive lens surgery. Monofocal IOLs are the traditional IOL type used during cataract surgery. These monofocal IOLs provide excellent distance vision, however spectacles are required for reading and intermediate distance tasks. The evolution of IOLs has been rapid over the last 50 years and one of the biggest advancements has been the development of multifocal IOLs. These lenses provide high levels of spectacle independence and currently are the most reliable lens for attaining both distance and near vision. There are many different designs of multifocal IOLs, all with their own unique optical properties, however there is little evidence to support which optical design provides the best visual outcome. Furthermore, feedback from patients implanted with such lenses has been disparate; multifocal IOLs cause a reduction in contrast sensitivity and create a unique optical phenomenon called dysphotopsia. These phenomenon, are the most common complaints with multifocal implantation, thus it is essential to investigate to understand how the optical properties of an multifocal IOL affect this photopic phenomenon. This research project is a randomised clinical investigation to compare the visual outcomes of the Biflex M multifocal IOL with the Bi flex 1.8 monofocal IOL. Approximately 100 study subjects will be enrolled and each subject will be implanted bilaterally with either the Medicontur Bi flex M multifocal IOL or the Medicontur Bi flex 1.8 monofocal IOL. Both IOLs are CE marked products sold in Europe and elsewhere for the purpose of replacing the natural crystalline lens of patients suffering from congenital, traumatic or naturally occurring cataracts. They are for long-term implantation in the capsular bag of the eye and are typically implanted after removal of the cataractous crystalline lens.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
15/SW/0027
Date of REC Opinion
9 Mar 2015
REC opinion
Further Information Favourable Opinion