Clinical trial NCT00425464: A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Synchrony Dual Optic Intraocular Lens in Patients Undergoing Cataract Extraction
Official title: A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Synchrony Dual Optic Intraocular Lens in Patients Undergoing Cataract Extraction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cataract
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2007-01-23
Enrollment: 410
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Distance corrected near visual acuity
timeFrame: 1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo
Secondary outcomes:
measure: Best corrected distance visual acuity
timeFrame: 1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
city: Los Alamitos
country: United States
facility: Long Beach Laser Center
state: California
city: Los Altos
country: United States
facility: Altos Eye Physicians
state: California
city: Sacramento
country: United States
facility: Grutzmacher & Lewis
state: California
city: West Hills
country: United States
facility: Davidorf Eye Group
state: California
city: Parker
country: United States
facility: Glaucoma Consultants of Colorado
state: Colorado
city: Boynton Beach
country: United States
facility: Katzen Eye Care and Laser Center
state: Florida
city: Honolulu
country: United States
facility: EyeSight Hawaii
state: Hawaii
city: Des Plaines
country: United States
facility: The Midwest Center for Sight
state: Illinois
city: Glenview
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Alexandria
country: United States
facility: Wallace Eye Surgery
state: Louisiana
city: Bloomington
country: United States
facility: Chu Vision Institute
state: Minnesota
city: Stillwater
country: United States
facility: Associated Eye Care
state: Minnesota
city: Chesterfield
country: United States
facility: Pepose Vision Institute
state: Missouri
city: Las Vegas
country: United States
facility: Nevada Eye Care
state: Nevada
city: Eugene
country: United States
facility: Drs. Fine, Hoffman & Packer
state: Oregon
city: Houston
country: United States
facility: Alkek Eye Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospitals and Clinics
state: Utah
city: Seattle
country: United States
facility: Northwest Eye Surgeons
state: Washington
city: Madison
country: United States
facility: Davis Duehr Dean
state: Wisconsin
Study officials:
References: