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Clinical Evaluation of the One-Piece Tecnis Multifocal Intraocular Lens (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: November 20, 2013
Last verified: November 2013
  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
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

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

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

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
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: 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
Results First Received: May 15, 2013
Last Updated: November 20, 2013
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on November 20, 2014