Clinical Trial to Evaluate the Model SC9 IOL Compared to the Model LI61SE IOL (Bausch & Lomb)

Study Overview
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Brief Summary
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To evaluate the Model SC9 Intraocular Lens for the improvement of near and intermediate vision when compared to a legally marketed monofocal IOL.

Detailed Description
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Subjects will be randomized to one of two groups. Group A, (Test Lens, Model SC9) or Group B, (Control Lens, Model LI61SE, Bausch and Lomb). Both groups will be randomized to receive either unilateral or bilateral implantation. No bilateral implantation is allowed in Phase 1. (50 subjects). Subjects will be followed for 36 Months.

Official Title
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A Clinical Trial to Evaluate the Safety and Effectiveness of Model SC9 Silicone IOL for the Visual Correction of Aphakia Secondary to the Removal of a Cataractous Lens in Adult Patients With or Without Presbyopia

Conditions
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Cataract

Intervention / Treatment
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* Device: Model SC9
* Device: Model LI61SE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Twenty-two years or older at the time of surgery and diagnosed with bilateral cataracts Able to comprehend and sign a statement of informed consent Willing and able to complete all required postoperative visits Calculated Lens Power within the available range for the study IOL's Planned cataract removal by phacoemulsification Potential postoperative visual acuity of BCDVA 0.2 LogMAR (20/32) or better in both eyes Subjects with less than 1.0D of corneal astigmatism Clear intraocular media other than cataract in the study eye Preoperative BCDVA worse than 0.2 LogMar (20/32) with or without glare Pupil size greater or equal to 6.0mm after dilation Exclusion Criteria: Any corneal abnormality, other than regular corneal astigmatism Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 LogMAR (20/32) Previous refractive surgery Amblyopia Clinical severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy) Diabetic retinopathy Extremely shallow anterior chamber, not due to swollen cataract Microphthalmos Previous retinal detachment Previous corneal surgery Recurrent severe anterior or posterior segment inflammation of unknown etiology Rubella or traumatic cataract Iris Neovascularization Glaucoma (uncontrolled or controlled with medication) Aniridia Optic nerve atrophy Damaged incomplete zonules Systemic disease that could increase the operative risk or confound the outcome Medications that, in the opinion of the investigator may confound the outcome or increase the risk to the subject (tamsulosin hydrochloride (Flomax) or other medications with similar side-effects (floppy iris syndrome)

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Model SC9<br>Investigational IOL | Device: Model SC9<br>* Experimental<br>|
| Active Comparator: Model LI61SE<br>FDA Approved IOL | Device: Model LI61SE<br>* Active Comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Visual Acuity Measurements using the LogMar Scale | Subjects must read 20/40 or better, distance corrected near visual acuity and 20/40 or better distance corrected intermediate visual acuity. This is achieved with the subject wearing their best corrected spectacle correction in place and reading a series of letters at 40cm/16 and 80cm/32. Total letters read for each line will determine their visual acuity | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defocus testing in 0.5D increments from -0.5 to -5.00D | A sub-set of 50 subjects will undergo defocus testing with their best distance correction in place. Minus Lenses in 0.5D increments will be placed over their best spectacle correction. Total letters read for each diopter will be recorded. Percentage of eyes with improvement of monocular depth of focus by at least 0.5D mean difference between the Model SC9 and control lens.(significance level of 0.025). To demonstrate superiority of at least 0.5D compared to the control lens >75% of eyes implanted with the Model SC9 should demonstrate superiority by at least 0.5D mean difference compared to the control lens. | 12 Months |