A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Synchrony Dual Optic Intraocular Lens in Patients Undergoing Cataract Extraction

Study Overview
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Brief Summary
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The purpose of the study is to determine if the Synchrony Dual Optic Accommodating Intraocular Lens can be used safely and effectively in post cataract extraction subjects

Official Title
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A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Synchrony Dual Optic Intraocular Lens in Patients Undergoing Cataract Extraction

Conditions
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Cataract

Intervention / Treatment
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* Device: Standard Monofocal Intraocular Lens
* Device: Synchrony® Dual Optic Intraocular Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be scheduled to undergo primary intraocular lens implantation for the correction of aphakia following extraction of a senile cataract. Patients must have a cataract causing reduction in visual acuity to a level of 20/40 or worse with BAT on medium setting. Patients must require Synchrony® Lens correction of 16D - 28D or, if participating in the control study, patients must require a Clariflex® (AMO®), Phacoflex® II models SI30NB (AMO®) or a SI40NB (AMO®). Patients must have ≤ 1.0 D of preoperative keratometric astigmatism. Patients must have clear intraocular media other than cataract(s). Patients must be age 50 or older at the time of implantation. Patient must be willing and able to return for all scheduled follow-up examinations and have signed a written informed consent form. Exclusion Criteria: Patients with any anterior segment pathology (anterior segment or corneal abnormalities, chronic uveitis, iritis, corneal dystrophy, pseudoexfoliation, etc.). Patients with glaucoma, glaucoma suspect or ocular hypertension, i.e., IOP > 22 mmHg. Patients with previous retinal detachment or retinal pathology including age- related macular degeneration. Patients with diabetes, currently being treated systemically. Patients with systemic or ocular disease that may prevent the patient from achieving uncorrected distance visual acuity of 20/32 or better post operatively. Patients with congenital bilateral cataract. Patients who require chronic administration of any topical ophthalmic or systemic medication that may affect accommodation such as mydriatic, cycloplegic and myotic agents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generation antihistamines, anticholinergic agents. The use of tamsulosin hydrochloride (Flomax®) is also excluded preoperatively due to floppy iris syndrome. Patients with best corrected visual acuity of 20/80 or worse in the fellow eye not attributable to cataract. Patients who are currently participating or have participated in an investigational study, other than this study, within the past 60 days. Patients who have had previous ocular surgery in the operative eye, including refractive surgery.

Ages Eligible for Study
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Minimum Age: 50 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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synchrony® Dual Optic Intraocular Lens<br> | Device: Synchrony® Dual Optic Intraocular Lens<br>* The Synchrony® Dual Optic Intraocular Lens (experimantal) arm is comprised of patients who meet all study eligibility criteria and will be implanted with a Synchrony® Dual Optic Intraocular Lens. Each study patient will undergo standard extracapsular cataract extraction through a clear corneal or limbal incision and circular continuous curvilinear capsulorhexis.<br>|
| Active Comparator: Standard Monofocal Intraocular Lens<br> | Device: Standard Monofocal Intraocular Lens<br>* The control (active comparator) arm is comprised of patients who meet all study eligibility criteria and will be implanted with a standard monofocal intraocular lens. Each study patient will undergo standard extracapsular cataract extraction through a clear corneal or limbal incision and circular continuous curvilinear capsulorhexis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance corrected near visual acuity |  | 1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected distance visual acuity |  | 1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo |