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

Clinical Evaluation of a Modified Light Transmission IOL

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).

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: modified light transmission intraocular lens; Device: monofocal 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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ZV9003; modified light transmission intraocular lens	Device: modified light transmission intraocular lens; violet visible light blocking acrylic intraocular lens; Other Names: ZV9003
Active Comparator: ZA9003; monofocal acrylic intraocular lens	Device: monofocal acrylic intraocular lens; conventional hydrophobic acrylic intraocular lens; Other Names: ZA9003

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Corrected Distance Visual Acuity	Snellen Equivalent visual acuity of 20/40 or better	One year
Uncorrected Distance Visual Acuity	Snellen Equivalent of 20/40 or better at one year	One Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast Sensitivity	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.	4-6 months
Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as "Good" or "Excellent".	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.	One Year

Collaborators and Investigators

• Sponsor: Abbott Medical Optics
• Investigators: Principal Investigator: Roger F. Steinert, M.D., University of California, Irvine, Dept. of Ophthalmology

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: September 3, 2008
• First Submitted That Met QC Criteria: September 4, 2008
• First Posted (Estimate): September 5, 2008

Study Record Updates

• Last Update Posted (Estimate): November 11, 2011
• Last Update Submitted That Met QC Criteria: October 6, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: cataract; intraocular lens; monofocal; acrylic
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: BBLK-102-PRSM