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Safety and Effectiveness of a Multifocal Intraocular Lens (IOL)

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ClinicalTrials.gov Identifier: NCT00747565
Recruitment Status : Completed
First Posted : September 5, 2008
Results First Posted : December 2, 2010
Last Update Posted : March 4, 2013
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Tracking Information
First Submitted Date  ICMJE September 3, 2008
First Posted Date  ICMJE September 5, 2008
Results First Submitted Date  ICMJE August 14, 2009
Results First Posted Date  ICMJE December 2, 2010
Last Update Posted Date March 4, 2013
Study Start Date  ICMJE November 2004
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2010)
  • Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye. [ Time Frame: One year ]
    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 [ Time Frame: One year ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 3, 2008)
distance visual acuity, near visual acuity, complications, adverse events [ Time Frame: 4-6 Months, 1 Year ]
Change History Complete list of historical versions of study NCT00747565 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2008)
Subject Satisfaction [ Time Frame: 4-6 Months, 1 Year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness of a Multifocal Intraocular Lens (IOL)
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cataract
Intervention  ICMJE
  • Device: Tecnis ZM900 Multifocal Intraocular Lens
    Investigational intraocular lens
  • Device: CeeOn 911A monofocal IOL
    Monofocal Control IOL
Study Arms  ICMJE
  • Experimental: Tecnis Multifocal IOL group
    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.
    Intervention: Device: Tecnis ZM900 Multifocal Intraocular Lens
  • Active Comparator: CeeOn 911A monofocal control IOL group
    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: Device: CeeOn 911A monofocal IOL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2010)
470
Original Actual Enrollment  ICMJE
 (submitted: September 3, 2008)
222
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00747565
Other Study ID Numbers  ICMJE DIOL-104-TCNS & DIOL-101-TCNS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott Medical Optics
Study Sponsor  ICMJE Abbott Medical Optics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Packer, M.D. Drs. Fine, Hoffman and Packer
PRS Account Abbott Medical Optics
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP