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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2013 by Carl Zeiss Meditec AG.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier:
First received: November 19, 2012
Last updated: December 18, 2013
Last verified: December 2013
The purpose of the study is to evaluate the far, intermediate and near visual acuities with a trifocal IOL.

Condition Intervention
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

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: January 2014
Estimated Primary Completion Date: January 2014 (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.


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

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01731743

Carl Zeiss Meditec AG
Berlin, Germany, 10589
Sponsors and Collaborators
Carl Zeiss Meditec AG
  More Information

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: December 18, 2013
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

ClinicalTrials.gov processed this record on May 23, 2016