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

• ClinicalTrials.gov Identifier: NCT00747227
• Recruitment Status: Completed
• First Posted: September 5, 2008
• Results First Posted: November 11, 2011
• Last Update Posted: November 11, 2011
• Sponsor: Abbott Medical Optics
• Information provided by (Responsible Party): Abbott Medical Optics

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Cataract	Device: modified light transmission intraocular lens; Device: monofocal acrylic intraocular lens	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of a Modified Light Transmission IOL
• Study Start Date: December 2006
• Actual Primary Completion Date: March 2009
• Actual Study Completion Date: June 2009

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Best Corrected Distance Visual Acuity [ Time Frame: One year ]
   Snellen Equivalent visual acuity of 20/40 or better
2. Uncorrected Distance Visual Acuity [ Time Frame: One Year ]
   Snellen Equivalent of 20/40 or better at one year

Secondary Outcome Measures :

1. Contrast Sensitivity [ Time Frame: 4-6 months ]
   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.
2. Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as "Good" or "Excellent". [ Time Frame: One Year ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Abbott Medical Optics
• ClinicalTrials.gov Identifier: NCT00747227
• Other Study ID Numbers: BBLK-102-PRSM
• First Posted: September 5, 2008
• Results First Posted: November 11, 2011
• Last Update Posted: November 11, 2011
• Last Verified: October 2011

Keywords provided by Abbott Medical Optics:

cataract; monofocal; intraocular lens; acrylic

Additional relevant MeSH terms:

Cataract; Lens Diseases; Eye Diseases