Safety and Efficacy of a Violet Visible Light Blocking Intraocular Lens (IOL) - Full Text View

Sponsored by:	Advanced Medical Optics
Information provided by:	Advanced Medical Optics
ClinicalTrials.gov Identifier:	NCT00747227

Purpose

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).

Condition	Intervention	Phase
Cataract	Device: modified light transmission intraocular lens Device: ZA9003 monofocal acrylic intraocular lens	Phase III

MedlinePlus related topics: Cataract

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clinical Evaluation of a Modified Light Transmission IOL

Further study details as provided by Advanced Medical Optics:

Primary Outcome Measures:

Visual Acuity [ Time Frame: 4-6 Months, One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

contrast sensitivity [ Time Frame: 4-6 months, one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	December 2006
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental modified light transmission intraocular lens	Device: modified light transmission intraocular lens violet visible light blocking acrylic intraocular lens
2: Active Comparator monofocal acrylic intraocular lens	Device: ZA9003 monofocal acrylic intraocular lens conventional hydrophobic acrylic intraocular lens

Detailed Description:

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.

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747227

Locations

United States, Arizona
Patrick Aiello, M.D.
Scottsdale, Arizona, United States, 85054
United States, Arkansas
Randall E. Cole, M.D.
Rogers, Arkansas, United States, 72756
United States, Connecticut
Aron Rose, M.D.
New Haven, Connecticut, United States, 06510
United States, Minnesota
Y. Ralph Chu, M.D.
Bloomington, Minnesota, United States, 55420
United States, Missouri
Steven Silverstein, M.D.
Kansas City, Missouri, United States, 64133
United States, Oregon
Jon-Marc Weston, M.D.
Roseburg, Oregon, United States, 97470
United States, Pennsylvania
Mark Blecher, M.D.
Philadelphia, Pennsylvania, United States, 19148
William Christie, M.D.
Cranberry Township, Pennsylvania, United States, 16066
United States, Rhode Island
Robert L. Bahr, M.D.
Providence, Rhode Island, United States, 02906
United States, South Dakota
Vance Thompson, M.D.
Sioux Falls, South Dakota, United States, 57105
United States, Washington
Jay Rudd, M.D.
Lacey, Washington, United States, 98503

Sponsors and Collaborators

Advanced Medical Optics

Investigators

Principal Investigator:

Roger F. Steinert, M.D.

University of California, Irvine, Dept. of Ophthalmology

More Information

Responsible Party:	Advanced Medical Optics ( Nick Tarantino, VP, Worldwide Clinical Research and Development )
Study ID Numbers:	BBLK-102-PRSM
Study First Received:	September 3, 2008
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00747227
Health Authority:	United States: Food and Drug Administration

Keywords provided by Advanced Medical Optics:

cataract
monofocal
intraocular lens
acrylic

Study placed in the following topic categories:

Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on January 14, 2009