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

January 19, 2007
September 16, 2013
November 2005
April 2013   (final data collection date for primary outcome measure)
Distance corrected near visual acuity [ Time Frame: 1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo ] [ Designated as safety issue: No ]
  • Distance corrected near visual acuity
  • Best corrected distance visual acuity
  • Cumulative incidence of adverse events
  • Contrast sensitivity
Complete list of historical versions of study NCT00425464 on ClinicalTrials.gov Archive Site
Best corrected distance visual acuity [ Time Frame: 1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Synchrony Dual Optic Intraocular Lens in Patients Undergoing Cataract Extraction
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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cataract
  • 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.

  • 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.

  • Experimental: Synchrony® Dual Optic Intraocular Lens
    Intervention: Device: Synchrony® Dual Optic Intraocular Lens
  • Active Comparator: Standard Monofocal Intraocular Lens
    Intervention: Device: Standard Monofocal Intraocular Lens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
410
April 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00425464
SYNC-601-IOL
Not Provided
Abbott Medical Optics
Abbott Medical Optics
Not Provided
Not Provided
Abbott Medical Optics
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP