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Safety and Effectiveness of a Multifocal Intraocular Lens (IOL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT00747565
First received: September 3, 2008
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Cataract
Device: Tecnis ZM900 Multifocal Intraocular Lens
Device: CeeOn 911A monofocal IOL

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 470
Study Start Date: November 2004
Study Completion Date: November 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Tecnis ZM900 Multifocal Intraocular Lens
Investigational 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.
Device: CeeOn 911A monofocal IOL
Monofocal Control IOL

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747565

Sponsors and Collaborators
Abbott Medical Optics
Investigators
Principal Investigator: Mark Packer, M.D. Drs. Fine, Hoffman and Packer
  More Information

No publications provided

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT00747565     History of Changes
Other Study ID Numbers: DIOL-104-TCNS & DIOL-101-TCNS
Study First Received: September 3, 2008
Results First Received: August 14, 2009
Last Updated: February 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Medical Optics:
cataract, tecnis, multifocal, intraocular lens

Additional relevant MeSH terms:
Cataract
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on November 25, 2014