Clinical Investigation of the Bi Flex M Multifocal IOL

Study Overview
=================
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.

Official Title
-----------------
Randomised Clinical Investigation of the Bi Flex M Multifocal Intraocular Lens

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: Bi flex M multifocal intraocular lens
* Device: Bi flex 1.8 monofocal intraocular lens


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bi flex M multifocal intraocular lens<br>Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens | Device: Bi flex M multifocal intraocular lens<br>* Multifocal intraocular lens<br>|
| Active Comparator: Bi flex 1.8 monofocal intraocular<br>Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens | Device: Bi flex 1.8 monofocal intraocular lens<br>* Standard monofocal intraocular lens<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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] | 
| 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] | 
| 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] | 
| 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] | 
| Defocus Curve Profiles | Visual acuity measurement (assessed in LogMAR) taken with differing levels of optical defocus | visit 1 (3-6 months) | 
| Long Term Defocus Curve Profiles | Assessed as a dioptric range and using the Defocus area metric | visit 2 (12-18 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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] | 
| 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] | 
| Pelli-Robson Monocular Contrast Sensitivity | Monocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test | Visit 1 [3-6 months] | 
| Pelli-Robson Binocular Contrast Sensitivity | Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test | Visit 1 [3-6 months] | 
| 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] | 
| Contrast Sensitivity CSV-1000 | Binocular Assessment of Contrast Sensitivity at threshold using the CSV-1000 | Visit 1 [3-6 months] | 
| 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) | 
| 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) | 
| 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) | 
| Glare | Assessed as the glare area size Scale 0 to 100 Higher score = larger area = worse outcome | visit 1 (3-6 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lenses, Intraocular