A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Synchrony Dual Optic Intraocular Lens in Patients Undergoing Cataract Extraction

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

Study Overview

• Status: Terminated
• Conditions: Cataract
• Intervention / Treatment: Device: Synchrony® Dual Optic Intraocular Lens; Device: Standard Monofocal Intraocular Lens

• Study Type: Interventional
• Enrollment (Actual): 410
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Laguna Hills, California, United States, 92653
      • Harvard Eye Associates
    • Los Alamitos, California, United States, 90720
      • Long Beach Laser Center
    • Los Altos, California, United States, 94024
      • Altos Eye Physicians
    • Sacramento, California, United States, 95815
      • Grutzmacher & Lewis
    • West Hills, California, United States, 91307
      • Davidorf Eye Group
  • Colorado
    • Parker, Colorado, United States, 80134
      • Glaucoma Consultants of Colorado
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • Katzen Eye Care and Laser Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • EyeSight Hawaii
  • Illinois
    • Des Plaines, Illinois, United States, 60016
      • The Midwest Center for Sight
    • Glenview, Illinois, United States, 60026
      • Northshore University HealthSystem
  • Louisiana
    • Alexandria, Louisiana, United States, 71303
      • Wallace Eye Surgery
  • Minnesota
    • Bloomington, Minnesota, United States
      • Chu Vision Institute
    • Stillwater, Minnesota, United States, 55082
      • Associated Eye Care
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Pepose Vision Institute
  • Nevada
    • Las Vegas, Nevada, United States, 89129
      • Nevada Eye Care
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Drs. Fine, Hoffman & Packer
  • Texas
    • Houston, Texas, United States, 77030
      • Alkek Eye Center
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospitals and Clinics
  • Washington
    • Seattle, Washington, United States, 98133
      • Northwest Eye Surgeons
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • Davis Duehr Dean

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Distance corrected near visual acuity	1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo

Secondary Outcome Measures

Outcome Measure	Time Frame
Best corrected distance visual acuity	1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo

Collaborators and Investigators

• Sponsor: Abbott Medical Optics

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: January 19, 2007
• First Submitted That Met QC Criteria: January 19, 2007
• First Posted (Estimate): January 23, 2007

Study Record Updates

• Last Update Posted (Estimate): September 19, 2013
• Last Update Submitted That Met QC Criteria: September 16, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: SYNC-601-IOL