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

Primary Purpose

Cataract

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
modified light transmission intraocular lens
monofocal acrylic intraocular lens
Sponsored by
Abbott Medical Optics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring cataract, monofocal, intraocular lens, acrylic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Patrick Aiello, M.D.
  • Randall E. Cole, M.D.
  • Aron Rose, M.D.
  • Y. Ralph Chu, M.D.
  • Steven Silverstein, M.D.
  • Jon-Marc Weston, M.D.
  • William Christie, M.D.
  • Mark Blecher, M.D.
  • Robert L. Bahr, M.D.
  • Vance Thompson, M.D.
  • Jay Rudd, M.D.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ZV9003

ZA9003

Arm Description

modified light transmission intraocular lens

monofocal acrylic intraocular lens

Outcomes

Primary Outcome Measures

Best Corrected Distance Visual Acuity
Snellen Equivalent visual acuity of 20/40 or better
Uncorrected Distance Visual Acuity
Snellen Equivalent of 20/40 or better at one year

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 3, 2008
Last Updated
October 6, 2011
Sponsor
Abbott Medical Optics
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1. Study Identification

Unique Protocol Identification Number
NCT00747227
Brief Title
Safety and Efficacy of a Violet Visible Light Blocking Intraocular Lens (IOL)
Official Title
Clinical Evaluation of a Modified Light Transmission IOL
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Optics

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
cataract, monofocal, intraocular lens, acrylic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ZV9003
Arm Type
Experimental
Arm Description
modified light transmission intraocular lens
Arm Title
ZA9003
Arm Type
Active Comparator
Arm Description
monofocal acrylic intraocular lens
Intervention Type
Device
Intervention Name(s)
modified light transmission intraocular lens
Other Intervention Name(s)
ZV9003
Intervention Description
violet visible light blocking acrylic intraocular lens
Intervention Type
Device
Intervention Name(s)
monofocal acrylic intraocular lens
Other Intervention Name(s)
ZA9003
Intervention Description
conventional hydrophobic acrylic intraocular lens
Primary Outcome Measure Information:
Title
Best Corrected Distance Visual Acuity
Description
Snellen Equivalent visual acuity of 20/40 or better
Time Frame
One year
Title
Uncorrected Distance Visual Acuity
Description
Snellen Equivalent of 20/40 or better at one year
Time Frame
One Year
Secondary Outcome Measure Information:
Title
Contrast Sensitivity
Description
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.
Time Frame
4-6 months
Title
Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as "Good" or "Excellent".
Description
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.
Time Frame
One Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger F. Steinert, M.D.
Organizational Affiliation
University of California, Irvine, Dept. of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Patrick Aiello, M.D.
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Randall E. Cole, M.D.
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72756
Country
United States
Facility Name
Aron Rose, M.D.
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Y. Ralph Chu, M.D.
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55420
Country
United States
Facility Name
Steven Silverstein, M.D.
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
Jon-Marc Weston, M.D.
City
Roseburg
State/Province
Oregon
ZIP/Postal Code
97470
Country
United States
Facility Name
William Christie, M.D.
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Mark Blecher, M.D.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States
Facility Name
Robert L. Bahr, M.D.
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Vance Thompson, M.D.
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Jay Rudd, M.D.
City
Lacey
State/Province
Washington
ZIP/Postal Code
98503
Country
United States

12. IPD Sharing Statement

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

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