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Sponsored by: |
Advanced Medical Optics |
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Information provided by: | Advanced Medical Optics |
ClinicalTrials.gov Identifier: | NCT00747565 |
To further evaluate the clinical performance of the ZM900 Tecnis Multifocal lens on a full complement of multifocal subjects for premarket approval
Condition | Intervention |
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Cataract |
Device: Tecnis ZM900 Multifocal Intraocular Lens |
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 |
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) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Presence of ocular pathology other than cataract such as:
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 |
Principal Investigator: | Mark Packer, M.D. | Drs. Fine, Hoffman and Packer |
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 |
cataract, tecnis, multifocal, intraocular lens |
Eye Diseases Cataract Lens Diseases |