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Safety and Effectiveness of Multifocal Intraocular Lens
This study is ongoing, but not recruiting participants.
Sponsored by: Advanced Medical Optics
Information provided by: Advanced Medical Optics
ClinicalTrials.gov Identifier: NCT00747565
  Purpose

To further evaluate the clinical performance of the ZM900 Tecnis Multifocal lens on a full complement of multifocal subjects for premarket approval


Condition Intervention
Cataract
Device: Tecnis ZM900 Multifocal Intraocular Lens

MedlinePlus related topics: Cataract
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Clinical Evaluation of the Tecnis Multifocal Intraocular Lens, Model ZM900, Expansion Study

Further study details as provided by Advanced Medical Optics:

Primary Outcome Measures:
  • distance visual acuity, near visual acuity, complications, adverse events [ Time Frame: 4-6 Months, 1 Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Subject Satisfaction [ Time Frame: 4-6 Months, 1 Year ] [ Designated as safety issue: No ]

Enrollment: 222
Study Start Date: March 2007
Estimated Study Completion Date: December 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Tecnis ZM900 Multifocal Intraocular Lens
    Investigational intraocular lens
Detailed Description:

To further evaluate safety & effectiveness of the lens; specifically, best corrected distance visual acuity will meet or exceed the FDA grid values, complication and adverse event rates will be similar to the FDA grid rates for posterior chamber IOLs, and near visual acuity will be improved compared to that of the monofocal control lens group in the initial evaluation of the ZM900 lens.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Visual potential of 20/30 or better in each study eye
  • Preoperative BCDVA worse than Snellen 20/40 or worse than 20/30 in the presence of glare (as measured using a Snellen chart with BAT at medium)
  • Naturally dilated pupil size (in dim light) > 4.0 mm (with no dilation medications) for each study eye
  • Preoperative corneal astigmatism of 1.0 D or less

Exclusion Criteria:

  • Use of systemic or ocular medications that may affect vision (the use of any miotic agent is specifically contraindicated)
  • Acute or chronic disease or illness that would increase the operative risk or confound the study outcome(s),(e.g., diabetes mellitus, immunocompromised, connective tissue disease, etc.)
  • Uncontrolled systemic or ocular disease
  • History of ocular trauma or prior ocular surgery or subjects expected to require retinal laser treatment or other surgical intervention
  • Presence of ocular pathology other than cataract such as:

    • Amblyopia or strabismus
    • Corneal abnormalities
    • Pupil abnormalities
    • Capsule or zonule abnormalities
    • Intraocular inflammation
    • Known pathology that may affect visual acuity and/or are predicted to cause future acuity losses to a level of 20/30 or worse (e.g. macular degeneration)
  • Requiring an intraocular lens outside the study diopter range
  • Contact lens usage prior to study procedure (time interval dependent upon contact lens type)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747565

Locations
United States, Arizona
Fishkind & Bakewell Eye Care & Surgery Center
Tucson, Arizona, United States, 85704
United States, California
Assil Eye Institute
Beverly Hills, California, United States, 90210
United States, Florida
Cape Coral Eye Center
Cape Coral, Florida, United States, 33904
United States, Indiana
Fort Wayne Eye Center
Fort Wayne, Indiana, United States, 46802
Eye Surgeons of Indiana
Indianapolis, Indiana, United States, 46256
United States, Kansas
Hunkeler Eye Institute
Overland Park, Kansas, United States, 66210
United States, Louisiana
Wallace Eye Surgery
Alexandria, Louisiana, United States, 71303
United States, Minnesota
Chu Laser Eye Institute
Bloomington, Minnesota, United States, 55420
Minnesota Eye Consultants
Bloomington, Minnesota, United States, 55431
United States, New York
Ophthalmic Consultants of Long Island
Rockville Center, New York, United States, 11570
United States, North Carolina
Carolina Vision
Fayetteville, North Carolina, United States, 28304
United States, Oregon
Drs. Fine, Hoffman and Packer
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Bucci Cataract & Laser Vision
Wilkes Barre, Pennsylvania, United States, 18702
United States, South Carolina
Storm Eye Institute (MUSC)
Charleston, South Carolina, United States, 29425
United States, Texas
Height Eye Center
Houston, Texas, United States, 77008
Whitsett Vision Group
Houston, Texas, United States, 77055
Sponsors and Collaborators
Advanced Medical Optics
Investigators
Principal Investigator: Mark Packer, M.D. Drs. Fine, Hoffman and Packer
  More Information

Responsible Party: Advanced Medical Optics ( Nicholas Tarantino, VP Worldwide Clinical Research and Development )
Study ID Numbers: DIOL-104-TCNS
Study First Received: September 3, 2008
Last Updated: September 3, 2008
ClinicalTrials.gov Identifier: NCT00747565  
Health Authority: United States: Food and Drug Administration

Keywords provided by Advanced Medical Optics:
cataract, tecnis, multifocal, intraocular lens

Study placed in the following topic categories:
Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on January 14, 2009