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Clinical Evaluation of the One-Piece Tecnis Multifocal IOL

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01210807
First received: June 17, 2010
Last updated: January 26, 2012
Last verified: January 2012
History of Changes
  Purpose

The purpose of this study is to evaluate near vision of the One-Piece Tecnis Multifocal lens (ZMB00) vs. the One-piece Tecnis monofocal lens (ZCB00)and additionally evaluate general postoperative outcomes of the One-Piece Tecnis Multifocal lens.


Condition Intervention Phase
Cataract
 Device: One-Piece Tecnis Multifocal IOL, Model ZMB00
Device: One-Piece Tecnis monofocal IOL, Model ZCB00
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the One-Piece Tecnis Multifocal IOL, Model ZMB00

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • Binocular distance-corrected near visual acuity [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Binocular best corrected distance visual acuity [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: November 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Comparison study
Comparison of bilaterally implanted Tecnis Multifocal IOL (ZMB00) subjects compared to bilaterally implanted Tecnis Monofocal IOL (ZCB00)subjects.
 Device: One-Piece Tecnis Multifocal IOL, Model ZMB00
One-piece Tecnis Multifocal IOL, Model ZMB00, implanted lens.
Other Name: ZMB00
Device: One-Piece Tecnis monofocal IOL, Model ZCB00
Control lens: One-Piece Tecnis monofocal IOL, Model, ZCB00, implanted lens.
Other Name: ZCB00

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • bilateral cataracts and otherwise healthy eyes
  • visual potential of Decimal 0.8 in each eye

Exclusion Criteria:

  • any medications affecting vision
  • any chronic disease/illness that would affect risk to subject or outcomes of the study
  • any ocular pathology/abnormalities that may affect visual outcomes or confound study results
  • desire for monovision
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01210807

Locations
Germany
Augenarzte Gemeinschaftspraxis Ahaus
Ahaus, Germany, 48683
University Eye Clinic
Heidelberg, Germany, 69120
Klinikum Ernst von Bergmann gGmbH
Potsdam, Germany, 14467
University Eye Clinic
Tubingen, Germany, 72076
Sponsors and Collaborators
Abbott Medical Optics
Investigators
Principal Investigator: Peter Szurman, PD Dr. med.
  More Information

No publications provided

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01210807     History of Changes
Other Study ID Numbers: DIOL-105-TMF1
Study First Received: June 17, 2010
Last Updated: January 26, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013