Clinical Investigation of the Bi Flex M Multifocal IOL

Dr Phillip J Buckhurst

Status and phase

Completed

Phase 4

Conditions

Cataract

Treatments

Device: Bi flex 1.8 monofocal intraocular lens

Device: Bi flex M multifocal intraocular lens

Study type

Interventional

Funder types

Other

Identifiers

NCT02338882

MC001

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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