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:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT00425464
First received: January 19, 2007
Last updated: September 16, 2013
Last verified: September 2013
  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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: September 16, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 19, 2014