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

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ClinicalTrials.gov Identifier: NCT01731743
Recruitment Status : Completed
First Posted : November 22, 2012
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Carl Zeiss Meditec AG

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

Condition or disease Intervention/treatment Phase
Cataract Device: AT LISA tri 839MP Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Arm Intervention/treatment
implantation of a trifocal IOL (AT LISA tri 839MP) Device: AT LISA tri 839MP



Primary Outcome Measures :
  1. Intermediate visual acuity [ Time Frame: up to 3 months postoperatively ]
    Monocular and binocular uncorrected and best distance corrected


Secondary Outcome Measures :
  1. near and far visual acuity [ Time Frame: 1 and 3 month postoperatively ]
    Monocular and binocular uncorrected and best distance corrected


Other Outcome Measures:
  1. Patient satisfaction and spectacle independence [ Time Frame: 1 and 3 month postoperatively ]


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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01731743


Locations
Germany
Carl Zeiss Meditec AG
Berlin, Germany, 10589
Sponsors and Collaborators
Carl Zeiss Meditec AG

Responsible Party: Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier: NCT01731743     History of Changes
Other Study ID Numbers: 839 MP HEN 402-11
First Posted: November 22, 2012    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases