A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Synchrony Dual Optic Intraocular Lens in Patients Undergoing Cataract Extraction
1 other identifier
interventional
410
1 country
20
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2005
Longer than P75 for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 19, 2007
CompletedFirst Posted
Study publicly available on registry
January 23, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedSeptember 19, 2013
September 1, 2013
7.4 years
January 19, 2007
September 16, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Distance corrected near visual acuity
1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo
Secondary Outcomes (1)
Best corrected distance visual acuity
1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo
Study Arms (2)
Synchrony® Dual Optic Intraocular Lens
EXPERIMENTALStandard Monofocal Intraocular Lens
ACTIVE COMPARATORInterventions
The control (active comparator) arm is comprised of patients who meet all study eligibility criteria and will be implanted with a standard monofocal intraocular lens. Each study patient will undergo standard extracapsular cataract extraction through a clear corneal or limbal incision and circular continuous curvilinear capsulorhexis.
The Synchrony® Dual Optic Intraocular Lens (experimantal) arm is comprised of patients who meet all study eligibility criteria and will be implanted with a Synchrony® Dual Optic Intraocular Lens. Each study patient will undergo standard extracapsular cataract extraction through a clear corneal or limbal incision and circular continuous curvilinear capsulorhexis.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Harvard Eye Associates
Laguna Hills, California, 92653, United States
Long Beach Laser Center
Los Alamitos, California, 90720, United States
Altos Eye Physicians
Los Altos, California, 94024, United States
Grutzmacher & Lewis
Sacramento, California, 95815, United States
Davidorf Eye Group
West Hills, California, 91307, United States
Glaucoma Consultants of Colorado
Parker, Colorado, 80134, United States
Katzen Eye Care and Laser Center
Boynton Beach, Florida, 33426, United States
EyeSight Hawaii
Honolulu, Hawaii, 96817, United States
The Midwest Center for Sight
Des Plaines, Illinois, 60016, United States
NorthShore University HealthSystem
Glenview, Illinois, 60026, United States
Wallace Eye Surgery
Alexandria, Louisiana, 71303, United States
Chu Vision Institute
Bloomington, Minnesota, United States
Associated Eye Care
Stillwater, Minnesota, 55082, United States
Pepose Vision Institute
Chesterfield, Missouri, 63017, United States
Nevada Eye Care
Las Vegas, Nevada, 89129, United States
Drs. Fine, Hoffman & Packer
Eugene, Oregon, 97401, United States
Alkek Eye Center
Houston, Texas, 77030, United States
University of Utah Hospitals and Clinics
Salt Lake City, Utah, 84132, United States
Northwest Eye Surgeons
Seattle, Washington, 98133, United States
Davis Duehr Dean
Madison, Wisconsin, 53715, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2007
First Posted
January 23, 2007
Study Start
November 1, 2005
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
September 19, 2013
Record last verified: 2013-09