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Clinical Evaluation of the One-Piece Tecnis Multifocal Intraocular Lens (IOL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01210807
First Posted: September 29, 2010
Last Update Posted: November 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Abbott Medical Optics
  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 Device: One-Piece Tecnis monofocal IOL, Model ZCB00 Phase 4

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

Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm [ Time Frame: 4-6 Months ]
    Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/24 for the Multifocal Group. Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/81 for the Monofocal Group.


Secondary Outcome Measures:
  • Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity [ Time Frame: 4-6 months ]

Enrollment: 70
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: Multifocal Intraocular Lens
ZMB00 multifocal intraocular lens
Device: One-Piece Tecnis Multifocal IOL
One-piece Tecnis Multifocal IOL, Model ZMB00, implanted lens.
Other Name: Model ZMB00
Active Comparator: Monofocal Intraocular Lens
ZCB00 monofocal intraocular lens
Device: One-Piece Tecnis monofocal IOL, Model ZCB00
Control lens: One-Piece Tecnis monofocal IOL, Model, ZCB00, implanted lens.
Other Name: ZCB00

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01210807     History of Changes
Other Study ID Numbers: DIOL-105-TMF1
First Submitted: June 17, 2010
First Posted: September 29, 2010
Results First Submitted: May 15, 2013
Results First Posted: December 13, 2013
Last Update Posted: November 2, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases