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

Phase 3

Terminated

• Conditions: Cataract
• Interventions: Device: Synchrony® Dual Optic Intraocular Lens; Device: Standard Monofocal Intraocular Lens

• 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

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2007-01-19
• Study First Submitted QC: 2007-01-19
• Study First Posted: 2007-01-23
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Disposition First Submitted: 2013-04-11
• Disposition First Submitted QC: 2013-04-11
• Disposition First Posted: 2013-04-17
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 410

Inclusion Criteria

1. Patients must be scheduled to undergo primary intraocular lens implantation for the correction of aphakia following extraction of a senile cataract.
2. Patients must have a cataract causing reduction in visual acuity to a level of 20/40 or worse with BAT on medium setting.
3. 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®).
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 examinations and have signed a written informed consent form.

Exclusion Criteria

1. Patients with any anterior segment pathology (anterior segment or corneal abnormalities, 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- related macular degeneration.
4. Patients with diabetes, currently being treated systemically.
5. Patients with systemic or ocular disease that may prevent the patient from achieving uncorrected 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 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.
8. Patients with best corrected visual acuity of 20/80 or worse in the fellow eye not attributable to cataract.
9. Patients who are currently participating or have participated in an investigational study, other than this study, within the past 60 days.
10. Patients who have had previous ocular surgery in the operative eye, including refractive surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Synchrony® Dual Optic Intraocular Lens	Synchrony® Dual Optic Intraocular Lens	-
Standard Monofocal Intraocular Lens	Standard Monofocal Intraocular Lens	-

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)

Wallace Eye Surgery; 🇺🇸 Alexandria, Louisiana, United States

Drs. Fine, Hoffman & Packer; 🇺🇸 Eugene, Oregon, United States

Associated Eye Care; 🇺🇸 Stillwater, Minnesota, United States

University of Utah Hospitals and Clinics; 🇺🇸 Salt Lake City, Utah, United States

Pepose Vision Institute; 🇺🇸 Chesterfield, Missouri, United States

Harvard Eye Associates; 🇺🇸 Laguna Hills, California, United States

Grutzmacher & Lewis; 🇺🇸 Sacramento, California, United States

Davidorf Eye Group; 🇺🇸 West Hills, California, 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

Nevada Eye Care; 🇺🇸 Las Vegas, Nevada, United States

Davis Duehr Dean; 🇺🇸 Madison, Wisconsin, United States

Long Beach Laser Center; 🇺🇸 Los Alamitos, California, United States

Altos Eye Physicians; 🇺🇸 Los Altos, California, United States

Alkek Eye Center; 🇺🇸 Houston, Texas, United States

Northwest Eye Surgeons; 🇺🇸 Seattle, Washington, United States

Katzen Eye Care and Laser Center; 🇺🇸 Boynton Beach, Florida, United States

Chu Vision Institute; 🇺🇸 Bloomington, Minnesota, United States

Glaucoma Consultants of Colorado; 🇺🇸 Parker, Colorado, United States