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

Stopped early · Phase 3

Conditions studied: Cataract

In brief

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

Key facts

Study ID: NCT00425464
Run by: Abbott Medical Optics
People needed: 410
Starts: 2005-11-01
Expected to finish: 2013-04-01
Last updated by the study team: 2013-09-19

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Harvard Eye Associates — Laguna Hills, California, United States
Long Beach Laser Center — Los Alamitos, California, United States
Altos Eye Physicians — Los Altos, California, United States
Grutzmacher & Lewis — Sacramento, California, United States
Davidorf Eye Group — West Hills, California, United States
Glaucoma Consultants of Colorado — Parker, Colorado, United States
Katzen Eye Care and Laser Center — Boynton Beach, Florida, United States
EyeSight Hawaii — Honolulu, Hawaii, United States
The Midwest Center for Sight — Des Plaines, Illinois, United States
NorthShore University HealthSystem — Glenview, Illinois, United States
Wallace Eye Surgery — Alexandria, Louisiana, United States
Chu Vision Institute — Bloomington, Minnesota, United States
Associated Eye Care — Stillwater, Minnesota, United States
Pepose Vision Institute — Chesterfield, Missouri, United States
Nevada Eye Care — Las Vegas, Nevada, United States
Drs. Fine, Hoffman & Packer — Eugene, Oregon, United States
Alkek Eye Center — Houston, Texas, United States
University of Utah Hospitals and Clinics — Salt Lake City, Utah, United States
Northwest Eye Surgeons — Seattle, Washington, United States
Davis Duehr Dean — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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