Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and performance of the SBL-3 intraocular lens.

Detailed Description
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The purpose of this study is to evaluate the safety (adverse events) and performance (visual acuity, spectacle independence) of the SBL-3 intraocular lens.

Official Title
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Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens

Conditions
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Cataracts, Presbyopia

Intervention / Treatment
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* Device: SBL-3 multifocal intraocular lens
* Device: Control monofocal intraocular lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 22 years of age, of any race and either gender Operable, age related cataract grade in both eyes Patients who require an intraocular lens (IOL) power in the range of 15 D - 30 D only Able to comprehend and sign a statement of informed consent Calculated lens power within the available supply range Planned cataract removal by phacoemulsification Potential postoperative visual acuity of 0.2 Logarithm of the Minimum Angle of Resolution (logMAR) or better in both eyes In good general and ocular health Patients with preoperative astigmatism ≤1.0 D Note: Corneal incisions made to reduce astigmatism will not be allowed during the course of the study. Clear intraocular media other than cataract in study eyes Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR The subject must be able to undergo second eye surgery between 7 days and 30 days of the first eye surgery Able to competently complete testing Willing and able to attend study visits Exclusion Criteria: Previous intraocular surgery Preoperative photopic pupil size of < 2.75 mm Previous corneal refractive surgery Any inflammation or edema (swelling) of the cornea 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 Subjects who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than neodymium-doped yttrium aluminium garnet (nd:YAG) capsulotomy) Amblyopia Clinically significant ptosis Clinically severe corneal dystrophy (eg., epithelial, stromal, or endothelial dystrophy), keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or kerectasia Diabetic Retinopathy Extremely shallow anterior chamber, not due to swollen cataract Microphthalmia Previous retinal detachment Previous corneal transplant Severe dry eye Recurrent severe anterior or posterior segment inflammation of unknown etiology Systemic medications that may confound the outcome or increase the risk to the subject in the opinion of the Investigator [tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome)] Rubella or traumatic cataract Iris neovascularization Glaucoma (medically controlled or uncontrolled) Aniridia Chronic severe uveitis Optic nerve atrophy Corneal decompensation Greater than 1.0 D of astigmatism History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.) Pseudoexfoliation syndrome Iris atrophy Pupil abnormalities (e.g., corectopia) Aniseikonia An acute or chronic disease or illness that may confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness) Pregnant, lactating, or planning to become pregnant during the course of the trial Note: Subjects who become pregnant during the study will not be discontinued; however, data may be excluded from the effectiveness analyses because pregnancy can alter refraction and visual acuity results. Participation in another clinical trial within 30 days of study start

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
Interventional Model Description: SBL-3 multifocal intraocular lens
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBL-3 multifocal intraocular lens<br>The SBL-3 intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group | Device: SBL-3 multifocal intraocular lens<br>* The SBL-3 intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group<br>|
| Active Comparator: Control monofocal intraocular lens<br>The Control intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group | Device: Control monofocal intraocular lens<br>* The Control intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| photopic, distance corrected, monocular near visual acuity | a measure of near vision | 1 year following implantation | 
| presence or absence of adverse events | presence or absence of adverse events | 1 year following implantation | 
| photopic, distance corrected, monocular intermediate visual acuity | a measure of intermediate vision | 1 year following implantation | 
| photopic, best corrected, monocular distance visual acuity | a measure of distance vision | 1 year following implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who are independent of spectacles | a measure of the independence from spectacles | 1 year following implantation |