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Safety and Efficacy of a Violet Visible Light Blocking Intraocular Lens (IOL)

NCT ID: NCT00747227

Last Updated: 2011-11-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-06-30

Brief Summary

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The purpose of this study is to evaluate the safety and effectiveness of a new investigational modified light transmission monofocal intraocular lens compared to a conventional intraocular lens (IOL).

Detailed Description

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The investigational IOL will be found to be safe and effective with respect to visual acuity, color vision, contrast sensitivity and complications and will be similar to results for the ZA9003 control eyes. Complication rates and adverse event rates will be within the FDA grid for posterior chamber IOLs.

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ZV9003

modified light transmission intraocular lens

Group Type EXPERIMENTAL

modified light transmission intraocular lens

Intervention Type DEVICE

violet visible light blocking acrylic intraocular lens

ZA9003

monofocal acrylic intraocular lens

Group Type ACTIVE_COMPARATOR

monofocal acrylic intraocular lens

Intervention Type DEVICE

conventional hydrophobic acrylic intraocular lens

Interventions

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modified light transmission intraocular lens

violet visible light blocking acrylic intraocular lens

Intervention Type DEVICE

monofocal acrylic intraocular lens

conventional hydrophobic acrylic intraocular lens

Intervention Type DEVICE

Other Intervention Names

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ZV9003 ZA9003

Eligibility Criteria

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Inclusion Criteria

* Age 18 years of age or older
* Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned
* Visual potential in both eyes of 20/30 Snellen or better after cataract removal and IOL implantation
* Preoperative corneal astigmatism of 1.5 diopters or less

Exclusion Criteria

* Use of systemic or ocular medications that may affect vision
* Uncontrolled systemic or recurrent ocular disease
* Requiring an intraocular lens \<15.0 or \>26.0 diopters
* Abnormal results with the Farnsworth-Munsell D-15 and/or Ishihara color plates
* History of ocular trauma or prior ocular surgery
* Known pathology that may affect visual acuity or visual field
* Corneal abnormalities
* Pupil abnormalities
* Capsule or zonular abnormalities
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Medical Optics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roger F. Steinert, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine, Dept. of Ophthalmology

Locations

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Patrick Aiello, M.D.

Scottsdale, Arizona, United States

Site Status

Randall E. Cole, M.D.

Rogers, Arkansas, United States

Site Status

Aron Rose, M.D.

New Haven, Connecticut, United States

Site Status

Y. Ralph Chu, M.D.

Bloomington, Minnesota, United States

Site Status

Steven Silverstein, M.D.

Kansas City, Missouri, United States

Site Status

Jon-Marc Weston, M.D.

Roseburg, Oregon, United States

Site Status

William Christie, M.D.

Cranberry Township, Pennsylvania, United States

Site Status

Mark Blecher, M.D.

Philadelphia, Pennsylvania, United States

Site Status

Robert L. Bahr, M.D.

Providence, Rhode Island, United States

Site Status

Vance Thompson, M.D.

Sioux Falls, South Dakota, United States

Site Status

Jay Rudd, M.D.

Lacey, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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BBLK-102-PRSM

Identifier Type: -

Identifier Source: org_study_id