Clinical Investigation of the Bi Flex M Multifocal IOL

NCT ID: NCT02338882

Last Updated: 2019-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2019-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bi flex M multifocal intraocular lens

Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens

Group Type: EXPERIMENTAL

Bi flex M multifocal intraocular lens

Intervention Type: DEVICE

Multifocal intraocular lens

Bi flex 1.8 monofocal intraocular

Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens

Group Type: ACTIVE_COMPARATOR

Bi flex 1.8 monofocal intraocular lens

Intervention Type: DEVICE

Standard monofocal intraocular lens

Interventions

Bi flex M multifocal intraocular lens

Multifocal intraocular lens

Intervention Type: DEVICE

Bi flex 1.8 monofocal intraocular lens

Standard monofocal intraocular lens

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BMI Southend Hospital

OTHER

Sponsor Role: collaborator

Dr Phillip J Buckhurst

OTHER

Sponsor Role: lead

Responsible Party

Dr Phillip J Buckhurst

Associate Professor (Senior Lecturer)

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Phillip J Buckhurst, PhD

Role: PRINCIPAL_INVESTIGATOR

Plymouth University

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MC001

Identifier Type: -

Identifier Source: org_study_id