A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Synchrony Dual Optic Intraocular Lens in Patients Undergoing Cataract Extraction
- Conditions
- Cataract
- Registration Number
- NCT00425464
- Lead Sponsor
- Abbott Medical Optics
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 410
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Distance corrected near visual acuity 1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo
- Secondary Outcome Measures
Name Time Method Best corrected distance visual acuity 1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo
Trial Locations
- Locations (20)
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
Scroll for more (10 remaining)Harvard Eye Associates🇺🇸Laguna Hills, California, United States