A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Synchrony Dual Optic Intraocular Lens in Patients Undergoing Cataract Extraction
NCT ID: NCT00425464
Last Updated: 2013-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
410 participants
INTERVENTIONAL
2005-11-30
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Synchrony® Dual Optic Intraocular Lens
Synchrony® Dual Optic Intraocular Lens
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.
Standard Monofocal Intraocular Lens
Standard Monofocal Intraocular Lens
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.
Interventions
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Standard Monofocal Intraocular Lens
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.
Synchrony® Dual Optic Intraocular Lens
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
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Inclusion Criteria
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
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.
50 Years
ALL
No
Sponsors
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Abbott Medical Optics
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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SYNC-601-IOL
Identifier Type: -
Identifier Source: org_study_id