Clinical Investigation of the Bi Flex M Multifocal IOL

Cataract Clinical Trial

Official title:

Randomised Clinical Investigation of the Bi Flex M Multifocal Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02338882
• Other study ID #: MC001
• Status: Completed
• Phase: Phase 4
• Start date: September 2015
• Est. completion date: May 31, 2019

Study information

• Verified date: September 2019
• Source: University of Plymouth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 31, 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Bi flex M multifocal intraocular lens
Multifocal intraocular lens
• Bi flex 1.8 monofocal intraocular lens
Standard monofocal intraocular lens

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Dr Phillip J Buckhurst	BMI Southend Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long Term Monocular Visual Acuity (VA)	Monocular Visual acuity at 12-18 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR	Visit 2 [12-18 months]
Primary	Long Term Binocular Visual Acuity (VA)	Binocular Visual acuity at 12-18 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR	Visit 2 [12-18 months]
Primary	Monocular Visual Acuity (VA)	Monocular Visual acuity at 3-6 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR	Visit 1 [3-6 months]
Primary	Binocular Visual Acuity (VA)	Binocular Visual acuity at 3-6 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR	Visit 1 [3-6 months]
Primary	Defocus Curve Profiles	Visual acuity measurement (assessed in LogMAR) taken with differing levels of optical defocus	visit 1 (3-6 months)
Primary	Long Term Defocus Curve Profiles	Assessed as a dioptric range and using the Defocus area metric	visit 2 (12-18 months)
Secondary	Long Term Monocular Pelli-Robson Contrast Sensitivity (CS)	MonocularContrast sensitivity assessed as a contrast threshold using the Pelli-Robson test	Visit 2 [12-18 months]
Secondary	Long Term Binocular Pelli-Robson Contrast Sensitivity (CS)	Binocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test	Visit 2 [12-18 month]
Secondary	Pelli-Robson Monocular Contrast Sensitivity	Monocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test	Visit 1 [3-6 months]
Secondary	Pelli-Robson Binocular Contrast Sensitivity	Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test	Visit 1 [3-6 months]
Secondary	Long Term Contrast Sensitivity CSV-1000	Binocular Assessment of Contrast Sensitivity at threshold using the Contrast sensitivity vision(CSV) CSV-1000	Visit 2 [12-18 months]
Secondary	Contrast Sensitivity CSV-1000	Binocular Assessment of Contrast Sensitivity at threshold using the CSV-1000	Visit 1 [3-6 months]
Secondary	Long Term Reading Performance	Assessed as the critical print size and using the reading performance index. Uses Radner reading chart and logarithmic Radner scale (LogRAD) Lower LogRAD equals smaller print size	Visit 2 (12-18 months)
Secondary	Reading Performance	Assessed as the critical print size and using the reading performance index Logarithmic Radner scale (LogRAD) Lower LogRAD equals small print size	visit 1 (3-6 months)
Secondary	Long Term Glare	Assessed as the glare area size Scale 0 to 100 Higher scores = larger glare area =worse outcome	Visit 2 (12-18 months)
Secondary	Glare	Assessed as the glare area size Scale 0 to 100 Higher score = larger area = worse outcome	visit 1 (3-6 months)