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Safety and Effectiveness of a Multifocal Intraocular Lens (IOL)

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tecnis ZM900 Multifocal Intraocular Lens
CeeOn 911A monofocal IOL
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, tecnis, multifocal, intraocular lens

Eligibility Criteria

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

Inclusion Criteria:

  • Visual potential of 20/30 or better in each study eye
  • Preoperative BCDVA worse than Snellen 20/40 or worse than 20/30 in the presence of glare (as measured using a Snellen chart with BAT at medium)
  • Naturally dilated pupil size (in dim light) > 4.0 mm (with no dilation medications) for each study eye
  • Preoperative corneal astigmatism of 1.0 D or less

Exclusion Criteria:

  • Use of systemic or ocular medications that may affect vision (the use of any miotic agent is specifically contraindicated)
  • Acute or chronic disease or illness that would increase the operative risk or confound the study outcome(s),(e.g., diabetes mellitus, immunocompromised, connective tissue disease, etc.)
  • Uncontrolled systemic or ocular disease
  • History of ocular trauma or prior ocular surgery or subjects expected to require retinal laser treatment or other surgical intervention

  • Presence of ocular pathology other than cataract such as:

    • Amblyopia or strabismus
    • Corneal abnormalities
    • Pupil abnormalities
    • Capsule or zonule abnormalities
    • Intraocular inflammation
    • Known pathology that may affect visual acuity and/or are predicted to cause future acuity losses to a level of 20/30 or worse (e.g. macular degeneration)
  • Requiring an intraocular lens outside the study diopter range
  • Contact lens usage prior to study procedure (time interval dependent upon contact lens type)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Tecnis Multifocal IOL group

    CeeOn 911A monofocal control IOL group

    Arm Description

    Subjects implanted bilaterally with the Tecnis Multifocal IOL. Participants were enrolled in this arm in the original study and also in the expansion study. Outcomes of the first eye of each subject were analyzed for the primary study endpoints.

    Subjects implanted bilaterally with the CeeOn 911A monofocal IOL. Participants enrolled in this arm only in the original study; no control subjects were enrolled in the expansion study. Outcomes of the first eye of each subject were analyzed for the primary study endpoints.

    Outcomes

    Primary Outcome Measures

    Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye.
    Number of participants that achieved a best corrected distance visual acuity of 20/40 or better in the first eye. As most subjects were implanted bilaterally,"first eye" refers to the first implanted eye of each subject.
    Mean Binocular Distance Corrected Near Visual Acuity in Snellen
    Mean binocular near visual acuity with distance correction in place measured at 33 cm; Mean is reported in Snellen (e.g. 20/20, 20/40, etc.), standard deviation reported in ETDRS (Early treatment diabetic retinopathy study)eye chart log units.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 3, 2008
    Last Updated
    February 27, 2013
    Sponsor
    Abbott Medical Optics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00747565
    Brief Title
    Safety and Effectiveness of a Multifocal Intraocular Lens (IOL)
    Official Title
    Clinical Evaluation of the Tecnis Multifocal Intraocular Lens (IOL), Model ZM900, Original Study (DIOL-101-TCNS); Clinical Evaluation of the Tecnis Multifocal Intraocular Lens, Model ZM900, Expansion Study (DIOL-104-TCNS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2004 (undefined)
    Primary Completion Date
    January 2008 (Actual)
    Study Completion Date
    November 2008 (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
    To evaluate the safety and effectiveness of the ZM900 Tecnis Multifocal lens. Results from two studies (an original study with 125 multifocal and 123 monofocal subjects, protocol DIOL-101-TCNS, and an expansion study with 222 additional multifocal subjects, protocol DIOL-104-TCNS) are combined to evaluate the ZM900 Tecnis Multifocal lens vs. a monofocal control. The original study was conducted in 2004-2006; the expansion study was conducted in 2007-2008. Results from both studies were analyzed together for FDA approval.
    Detailed Description
    The original study was protocol DIOL-101-TCNS; the expansion study was protocol DIOL-104-TCNS. The study protocols were almost identical with the exception that no control subjects were enrolled in the expansion study; only additional multifocal subjects. All eligibility criteria and testing conducted in the expansion study was the same as that in the original study. The hypotheses were that best corrected distance visual acuity of the ZM900 lens would meet or exceed the FDA grid values, complication and adverse event rates of the ZM900 would be similar to the FDA grid rates for posterior chamber IOLs, and near visual acuity of the ZM900 lens would be improved compared to that of the monofocal control lens.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    470 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tecnis Multifocal IOL group
    Arm Type
    Experimental
    Arm Description
    Subjects implanted bilaterally with the Tecnis Multifocal IOL. Participants were enrolled in this arm in the original study and also in the expansion study. Outcomes of the first eye of each subject were analyzed for the primary study endpoints.
    Arm Title
    CeeOn 911A monofocal control IOL group
    Arm Type
    Active Comparator
    Arm Description
    Subjects implanted bilaterally with the CeeOn 911A monofocal IOL. Participants enrolled in this arm only in the original study; no control subjects were enrolled in the expansion study. Outcomes of the first eye of each subject were analyzed for the primary study endpoints.
    Intervention Type
    Device
    Intervention Name(s)
    Tecnis ZM900 Multifocal Intraocular Lens
    Intervention Description
    Investigational intraocular lens
    Intervention Type
    Device
    Intervention Name(s)
    CeeOn 911A monofocal IOL
    Intervention Description
    Monofocal Control IOL
    Primary Outcome Measure Information:
    Title
    Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye.
    Description
    Number of participants that achieved a best corrected distance visual acuity of 20/40 or better in the first eye. As most subjects were implanted bilaterally,"first eye" refers to the first implanted eye of each subject.
    Time Frame
    One year
    Title
    Mean Binocular Distance Corrected Near Visual Acuity in Snellen
    Description
    Mean binocular near visual acuity with distance correction in place measured at 33 cm; Mean is reported in Snellen (e.g. 20/20, 20/40, etc.), standard deviation reported in ETDRS (Early treatment diabetic retinopathy study)eye chart log units.
    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: Visual potential of 20/30 or better in each study eye Preoperative BCDVA worse than Snellen 20/40 or worse than 20/30 in the presence of glare (as measured using a Snellen chart with BAT at medium) Naturally dilated pupil size (in dim light) > 4.0 mm (with no dilation medications) for each study eye Preoperative corneal astigmatism of 1.0 D or less Exclusion Criteria: Use of systemic or ocular medications that may affect vision (the use of any miotic agent is specifically contraindicated) Acute or chronic disease or illness that would increase the operative risk or confound the study outcome(s),(e.g., diabetes mellitus, immunocompromised, connective tissue disease, etc.) Uncontrolled systemic or ocular disease History of ocular trauma or prior ocular surgery or subjects expected to require retinal laser treatment or other surgical intervention Presence of ocular pathology other than cataract such as: Amblyopia or strabismus Corneal abnormalities Pupil abnormalities Capsule or zonule abnormalities Intraocular inflammation Known pathology that may affect visual acuity and/or are predicted to cause future acuity losses to a level of 20/30 or worse (e.g. macular degeneration) Requiring an intraocular lens outside the study diopter range Contact lens usage prior to study procedure (time interval dependent upon contact lens type)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mark Packer, M.D.
    Organizational Affiliation
    Drs. Fine, Hoffman and Packer
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Effectiveness of a Multifocal Intraocular Lens (IOL)

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