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Safety and Effectiveness of Multifocal Intraocular Lens

2014-07-23 21:20:24 | BioPortfolio

Summary

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

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cataract

Intervention

Tecnis ZM900 Multifocal Intraocular Lens

Location

Fishkind & Bakewell Eye Care & Surgery Center
Tucson
Arizona
United States
85704

Status

Active, not recruiting

Source

Abbott Medical Optics

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:20:24-0400

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Medical and Biotech [MESH] Definitions

Insertion of an artificial lens to replace the natural CRYSTALLINE LENS after CATARACT EXTRACTION or to supplement the natural lens which is left in place.

Presence of an intraocular lens after cataract extraction.

Lenses, generally made of plastic or silicone, that are implanted into the eye in front of the natural EYE LENS, by the IRIS, to improve VISION, OCULAR. These intraocular lenses are used to supplement the natural lens instead of replacing it.

Partial or complete opacity on or in the lens or capsule of one or both eyes, impairing vision or causing blindness. The many kinds of cataract are classified by their morphology (size, shape, location) or etiology (cause and time of occurrence). (Dorland, 27th ed)

Absence of crystalline lens totally or partially from field of vision, from any cause except after cataract extraction. Aphakia is mainly congenital or as result of LENS DISLOCATION AND SUBLUXATION.

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