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

Sponsor
Abbott Medical Optics (Industry)
Overall Status
Completed
CT.gov ID
NCT00747227
Collaborator
(none)
250
Enrollment
11
Locations
2
Arms
30
Duration (Months)
22.7
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

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 DiseaseIntervention/TreatmentPhase
  • 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
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 :
Dec 1, 2006
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Jun 1, 2009

Arms and Interventions

ArmIntervention/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
  • Outcome Measures

    Primary Outcome Measures

    1. Best Corrected Distance Visual Acuity [One year]

      Snellen Equivalent visual acuity of 20/40 or better

    2. Uncorrected Distance Visual Acuity [One Year]

      Snellen Equivalent of 20/40 or better at one year

    Secondary Outcome Measures

    1. Contrast Sensitivity [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". [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    SiteCityStateCountryPostal Code
    1Patrick Aiello, M.D.ScottsdaleArizonaUnited States85054
    2Randall E. Cole, M.D.RogersArkansasUnited States72756
    3Aron Rose, M.D.New HavenConnecticutUnited States06510
    4Y. Ralph Chu, M.D.BloomingtonMinnesotaUnited States55420
    5Steven Silverstein, M.D.Kansas CityMissouriUnited States64133
    6Jon-Marc Weston, M.D.RoseburgOregonUnited States97470
    7William Christie, M.D.Cranberry TownshipPennsylvaniaUnited States16066
    8Mark Blecher, M.D.PhiladelphiaPennsylvaniaUnited States19148
    9Robert L. Bahr, M.D.ProvidenceRhode IslandUnited States02906
    10Vance Thompson, M.D.Sioux FallsSouth DakotaUnited States57105
    11Jay Rudd, M.D.LaceyWashingtonUnited States98503

    Sponsors and Collaborators

    • Abbott Medical Optics

    Investigators

    • Principal Investigator: Roger F. Steinert, M.D., University of California, Irvine, Dept. of Ophthalmology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Medical Optics
    ClinicalTrials.gov Identifier:
    NCT00747227
    Other Study ID Numbers:
    • BBLK-102-PRSM
    First Posted:
    Sep 5, 2008
    Last Update Posted:
    Nov 11, 2011
    Last Verified:
    Oct 1, 2011
    Keywords provided by Abbott Medical Optics
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details250 subjects from normal cataract populations who were undergoing primary phacoemulsification with lens implantation and did not have any other visually significant ocular pathologies were selected at 12 investigation sites across the country
    Pre-assignment Detail
    Arm/Group TitleZV9003 Intraocular LensZA9003 Intraocular Lens
    Arm/Group Descriptionmodified light transmission intraocular lensmonofocal acrylic intraocular lens
    Period Title: Overall Study
    STARTED126124
    COMPLETED120120
    NOT COMPLETED64

    Baseline Characteristics

    Arm/Group TitleZV9003 Intraocular LensZA9003 Intraocular LensTotal
    Arm/Group Descriptionmodified light transmission intraocular lensmonofocal acrylic intraocular lensTotal of all reporting groups
    Overall Participants126124250
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    73.3
    (8.0)
    71.5
    (8.0)
    72.4
    (8.0)
    Age, Customized (participants) [Number]
    <60 years
    4
    3.2%
    8
    6.5%
    12
    4.8%
    Between 60 and 69 years
    35
    27.8%
    41
    33.1%
    76
    30.4%
    Between 70 and 79 years
    57
    45.2%
    54
    43.5%
    111
    44.4%
    >=80
    30
    23.8%
    21
    16.9%
    51
    20.4%
    Sex: Female, Male (Count of Participants)
    Female
    78
    61.9%
    68
    54.8%
    146
    58.4%
    Male
    48
    38.1%
    56
    45.2%
    104
    41.6%
    Region of Enrollment (participants) [Number]
    United States
    126
    100%
    124
    100%
    250
    100%

    Outcome Measures

    1. Primary Outcome
    TitleBest Corrected Distance Visual Acuity
    DescriptionSnellen Equivalent visual acuity of 20/40 or better
    Time FrameOne year

    Outcome Measure Data

    Analysis Population Description
    One subject was excluded from the analysis because the ZV9003 lens was implanted in the first eye and the ZA900 lens was implanted in the second eye. All subjects in the outcomes analysis had the same lens in both eyes.
    Arm/Group TitleZV9003 Intraocular LensZA9003 Intraocular Lens
    Arm/Group Descriptionmodified light transmission intraocular lensmonofocal acrylic intraocular lens
    Measure Participants119120
    Number [participants]
    119
    94.4%
    120
    96.8%
    2. Secondary Outcome
    TitleContrast Sensitivity
    DescriptionContrast 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 Frame4-6 months

    Outcome Measure Data

    Analysis Population Description
    Binocular contrast sensitivity testing was reported for all binocular subjects with data available at the 4-6 month visit on 120 subjects in each group. One ZA9003 subject was tested at 3.0 cpd and not tested for 6.0 cpd through 18.0 cpd (mesopic and photopic). Testing for levels 6.0 through 18.0 were not reported.
    Arm/Group TitleZV9003 Intraocular LensZA9003 Intraocular Lens
    Arm/Group Descriptionmodified light transmission intraocular lensmonofocal acrylic intraocular lens
    Measure Participants120120
    Mesopic condition at 3.0 cpd
    1.62
    1.62
    Mesopic condition at 6.0 cpd
    1.65
    1.63
    Mesopic condition at 12.0 cpd
    1.14
    1.17
    Mesopic condition at 18.0 cpd
    0.60
    0.65
    Photopic condition at 3.0 cpd
    1.76
    1.74
    Photopic condition at 6.0 cpd
    1.91
    1.94
    Photopic condition at 12.0 cpd
    1.58
    1.59
    Photopic condition at 18.0 cpd
    1.09
    1.14
    3. Primary Outcome
    TitleUncorrected Distance Visual Acuity
    DescriptionSnellen Equivalent of 20/40 or better at one year
    Time FrameOne Year

    Outcome Measure Data

    Analysis Population Description
    One subject was excluded from the analysis because the ZV9003 lens was implanted in the first eye and the ZA900 lens was implanted in the second eye. All subjects in the outcomes analysis had the same lens in both eyes.
    Arm/Group TitleZV9003 Intraocular LensZA9003 Intraocular Lens
    Arm/Group Descriptionmodified light transmission intraocular lensmonofocal acrylic intraocular lens
    Measure Participants119120
    Number [participants]
    110
    87.3%
    116
    93.5%
    4. Secondary Outcome
    TitleSubject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as "Good" or "Excellent".
    DescriptionSubjects 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 FrameOne Year

    Outcome Measure Data

    Analysis Population Description
    Two subjects in the ZV9003 group did not complete the one year questionnaire.
    Arm/Group TitleZV9003 Intraocular LensZA9003 Intraocular Lens
    Arm/Group Descriptionmodified light transmission intraocular lensmonofocal acrylic intraocular lens
    Measure Participants118119
    Number [participants]
    112
    88.9%
    113
    91.1%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group TitleZV9003 Intraocular LensZA9003 Intraocular Lens
    Arm/Group Descriptionmodified light transmission intraocular lensmonofocal acrylic intraocular lens
    All Cause Mortality
    ZV9003 Intraocular LensZA9003 Intraocular Lens
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN)
    Serious Adverse Events
    ZV9003 Intraocular LensZA9003 Intraocular Lens
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total1/126 (0.8%) 1/124 (0.8%)
    Eye disorders
    Retinal Tear requiring secondary surgical intervention1/126 (0.8%) 11/124 (0.8%) 1
    Other (Not Including Serious) Adverse Events
    ZV9003 Intraocular LensZA9003 Intraocular Lens
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/126 (0%) 0/124 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    PIs may not publish or disclose study data without Sponsor's prior written approval.

    Results Point of Contact

    Name/TitleNicholas Taranatino, O.D., Head, Global Clinical Research & Devlopment
    OrganizationAbbott medical Optics, Inc.
    Phone866-427-8477 ext 8613
    Emailnicholas.tarantino@amo.abbott.com
    Responsible Party:
    Abbott Medical Optics
    ClinicalTrials.gov Identifier:
    NCT00747227
    Other Study ID Numbers:
    • BBLK-102-PRSM
    First Posted:
    Sep 5, 2008
    Last Update Posted:
    Nov 11, 2011
    Last Verified:
    Oct 1, 2011