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

Inclusion Criteria:

1. Patients must be scheduled to undergo primary intraocular lens implantation for thecorrection of aphakia following extraction of a senile cataract.

2. Patients must have a cataract causing reduction in visual acuity to a level of 20/40or worse with BAT on medium setting.

3. Patients must require Synchrony® Lens correction of 16D - 28D or, if participating inthe control study, patients must require a Clariflex® (AMO®), Phacoflex® II modelsSI30NB (AMO®) or a SI40NB (AMO®).

4. Patients must have ≤ 1.0 D of preoperative keratometric astigmatism.

5. Patients must have clear intraocular media other than cataract(s).

6. Patients must be age 50 or older at the time of implantation.

7. Patient must be willing and able to return for all scheduled follow-up examinationsand have signed a written informed consent form.

Exclusion Criteria:

1. Patients with any anterior segment pathology (anterior segment or cornealabnormalities, chronic uveitis, iritis, corneal dystrophy, pseudoexfoliation, etc.).

2. Patients with glaucoma, glaucoma suspect or ocular hypertension, i.e., IOP > 22 mmHg.

3. Patients with previous retinal detachment or retinal pathology including age- relatedmacular degeneration.

4. Patients with diabetes, currently being treated systemically.

5. Patients with systemic or ocular disease that may prevent the patient from achievinguncorrected distance visual acuity of 20/32 or better post operatively.

6. Patients with congenital bilateral cataract.

7. Patients who require chronic administration of any topical ophthalmic or systemicmedication that may affect accommodation such as mydriatic, cycloplegic and myoticagents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generationantihistamines, anticholinergic agents. The use of tamsulosin hydrochloride (Flomax®)is also excluded preoperatively due to floppy iris syndrome.

8. Patients with best corrected visual acuity of 20/80 or worse in the fellow eye notattributable to cataract.

9. Patients who are currently participating or have participated in an investigationalstudy, other than this study, within the past 60 days.

10. Patients who have had previous ocular surgery in the operative eye, includingrefractive surgery.