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Evaluation of Visual Acuity and Patient Satisfaction With AT LISA TRI 839MP Intraocular Lenses

This study is currently recruiting participants.
Verified November 2012 by Carl Zeiss Meditec AG
Sponsor:
Information provided by (Responsible Party):
Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier:
NCT01731743
First received: November 19, 2012
Last updated: November 22, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of the study is to evaluate the far, intermediate and near visual acuities with a trifocal IOL.


Condition Intervention
Cataract
 Device: AT LISA tri 839MP

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Carl Zeiss Meditec AG:

Primary Outcome Measures:
  • Intermediate visual acuity [ Time Frame: up to 3 months postoperatively ] [ Designated as safety issue: No ]
    Monocular and binocular uncorrected and best distance corrected


Secondary Outcome Measures:
  • near and far visual acuity [ Time Frame: 1 and 3 month postoperatively ] [ Designated as safety issue: No ]
    Monocular and binocular uncorrected and best distance corrected


Other Outcome Measures:
  • Patient satisfaction and spectacle independence [ Time Frame: 1 and 3 month postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
implantation of a trifocal IOL (AT LISA tri 839MP) Device: AT LISA tri 839MP

Detailed Description:

After bilateral cataract surgery, monocular and binocular uncorrected (UCVA) and best distance corrected visual acuity (BCVA) will be measured at far (4m), intermediate (80 cm) and near (40 cm) distance as well as the subjective refraction.

A patient questionnaire will be used to assess the patient satisfaction and spectacle independence.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Man or woman, over 50 years of age
  • Bilateral implantation of a trifocal intraocular lens
  • Capsular bag implantation

Exclusion Criteria:

  • Existing ocular pathology
  • Surgical complications
  • Corneal astigmatism ≥ 1.0D
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731743

Locations
Germany
Carl Zeiss Meditec AG Recruiting
Berlin, Germany, 10589
Contact: Peggy Schieritz, M. Sc.     +49 854001 ext 229     peggy.schieritz@zeiss.com    
Sponsors and Collaborators
Carl Zeiss Meditec AG
  More Information

No publications provided

Responsible Party: Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier: NCT01731743     History of Changes
Other Study ID Numbers: 839 MP HEN 402-11
Study First Received: November 19, 2012
Last Updated: November 22, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Ethics Committee
United Kingdom: National Institute for Health Research

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013