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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT00747227
First received: September 3, 2008
Last updated: October 6, 2011
Last verified: October 2011
  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: monofocal acrylic intraocular lens
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of a Modified Light Transmission IOL

Resource links provided by NLM:


Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • Best Corrected Distance Visual Acuity [ Time Frame: One year ] [ Designated as safety issue: No ]
    Snellen Equivalent visual acuity of 20/40 or better

  • Uncorrected Distance Visual Acuity [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Snellen Equivalent of 20/40 or better at one year


Secondary Outcome Measures:
  • Contrast Sensitivity [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
    Contrast sensitivity is the measurement of how faded an image may become before it can clearly be seen. Contrast sensitivity was measured in photopic and mesopic conditions at the following spatial frequencies: 3.0, 6.0, 12.0, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.

  • Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as "Good" or "Excellent". [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Subjects indicating a subjective response to a multiple choice question, "At the present time, would you say your eyesight using both eyes (with glasses or contact lenses, if you wear them) is excellent, good, fair, poor, or very poor or are you completely blind?", on a multi-item questionnaire administered by interviewer to determine subject satisfaction with their overall visual outcome at the one year visit.


Enrollment: 250
Study Start Date: December 2006
Study Completion Date: June 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZV9003
modified light transmission intraocular lens
Device: modified light transmission intraocular lens
violet visible light blocking acrylic intraocular lens
Other Name: ZV9003
Active Comparator: ZA9003
monofocal acrylic intraocular lens
Device: monofocal acrylic intraocular lens
conventional hydrophobic acrylic intraocular lens
Other Name: ZA9003

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
William Christie, M.D.
Cranberry Township, Pennsylvania, United States, 16066
Mark Blecher, M.D.
Philadelphia, Pennsylvania, United States, 19148
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
Abbott Medical Optics
Investigators
Principal Investigator: Roger F. Steinert, M.D. University of California, Irvine, Dept. of Ophthalmology
  More Information

No publications provided

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT00747227     History of Changes
Other Study ID Numbers: BBLK-102-PRSM
Study First Received: September 3, 2008
Results First Received: March 4, 2011
Last Updated: October 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Medical Optics:
cataract
monofocal
intraocular lens
acrylic

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 16, 2014