A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Synchrony Dual Optic Intraocular Lens in Patients Undergoing Cataract Extraction
This study has been terminated.
Sponsor:
Abbott Medical Optics
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT00425464
First received: January 19, 2007
Last updated: April 19, 2013
Last verified: April 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Cataract |
Device: Standard Monofocal Intraocular Lens Device: Synchrony® Dual Optic Intraocular Lens |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Abbott Medical Optics:
Primary Outcome Measures:
- Distance corrected near visual acuity [ Time Frame: 1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Best corrected distance visual acuity [ Time Frame: 1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo ] [ Designated as safety issue: No ]
| Enrollment: | 410 |
| Study Start Date: | November 2005 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Synchrony® Dual Optic Intraocular Lens |
Device: 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. |
| Active Comparator: Standard Monofocal Intraocular Lens |
Device: 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. |
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00425464
Locations
| United States, California | |
| Harvard Eye Associates | |
| Laguna Hills, California, United States, 92653 | |
| Long Beach Laser Center | |
| Los Alamitos, California, United States, 90720 | |
| Altos Eye Physicians | |
| Los Altos, California, United States, 94024 | |
| Grutzmacher & Lewis | |
| Sacramento, California, United States, 95815 | |
| Davidorf Eye Group | |
| West Hills, California, United States, 91307 | |
| United States, Colorado | |
| Glaucoma Consultants of Colorado | |
| Parker, Colorado, United States, 80134 | |
| United States, Florida | |
| Katzen Eye Care and Laser Center | |
| Boynton Beach, Florida, United States, 33426 | |
| United States, Hawaii | |
| EyeSight Hawaii | |
| Honolulu, Hawaii, United States, 96817 | |
| United States, Illinois | |
| The Midwest Center for Sight | |
| Des Plaines, Illinois, United States, 60016 | |
| NorthShore University HealthSystem | |
| Glenview, Illinois, United States, 60026 | |
| United States, Louisiana | |
| Wallace Eye Surgery | |
| Alexandria, Louisiana, United States, 71303 | |
| United States, Minnesota | |
| Chu Vision Institute | |
| Bloomington, Minnesota, United States | |
| Associated Eye Care | |
| Stillwater, Minnesota, United States, 55082 | |
| United States, Missouri | |
| Pepose Vision Institute | |
| Chesterfield, Missouri, United States, 63017 | |
| United States, Nevada | |
| Nevada Eye Care | |
| Las Vegas, Nevada, United States, 89129 | |
| United States, Oregon | |
| Drs. Fine, Hoffman & Packer | |
| Eugene, Oregon, United States, 97401 | |
| United States, Texas | |
| Alkek Eye Center | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| University of Utah Hospitals and Clinics | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Washington | |
| Northwest Eye Surgeons | |
| Seattle, Washington, United States, 98133 | |
| United States, Wisconsin | |
| Davis Duehr Dean | |
| Madison, Wisconsin, United States, 53715 | |
Sponsors and Collaborators
Abbott Medical Optics
More Information
Additional Information:
No publications provided
| Responsible Party: | Abbott Medical Optics |
| ClinicalTrials.gov Identifier: | NCT00425464 History of Changes |
| Other Study ID Numbers: | SYNC-601-IOL |
| Study First Received: | January 19, 2007 |
| Last Updated: | April 19, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cataract Lens Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 16, 2013