A Multi Focal Visual Outcome Study Using Different Near Additions

Study Overview
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Brief Summary
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A multi-centre non-randomized clinical investigation to assess multifocal visual outcomes using different near additions, for the treatment of aphakia after cataract removal.

Official Title
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Clinical Investigational Plan of the Rayner M-flex Multifocal Intraocular Lens (IOL) With Different Near Additions

Conditions
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Cataract, Aphakia

Intervention / Treatment
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* Device: Visual Acuity
* Device: Contrast sensitivity
* Device: Reading Speed
* Procedure: Eye Health


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age-related cataract patients undergoing cataract surgery where the cataractous lens has been removed by phacoemulsification, with circular tear capsulotomy, leaving the posterior capsule intact 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: Pre-existing 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 pre-operative corneal astigmatism Subjects who are expected to require retinal laser treatment Previous intraocular and/or corneal surgery History of uveitis, glaucoma, proliferative diabetic retinopathy or IDDM, 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 in the 6-months follow-up period Children under the age of 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Visual Acuity|Assessment of visual acuity|
|Device: Contrast sensitivity|Assessment of contrast sensitivity|
|Device: Reading Speed|Assessment of reading speed|
|Procedure: Eye Health|Examination of eye health through use of a slitlamp/ photography. Assessment of Intraocular Pressure.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity at distance and near |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of clear vision |  | 1 year | 
| Reading speed |  | 1 year | 
| Cntrast sensitivity |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MFlex, Multifocal, 630F