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

January 25, 2018 updated by: Carl Zeiss Meditec AG
The purpose of the study is to evaluate the far, intermediate and near visual acuities with a trifocal IOL.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Berlin, Germany, 10589
        • Carl Zeiss Meditec AG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: implantation of a trifocal IOL (AT LISA tri 839MP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intermediate visual acuity
Time Frame: up to 3 months postoperatively
Monocular and binocular uncorrected and best distance corrected
up to 3 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
near and far visual acuity
Time Frame: 1 and 3 month postoperatively
Monocular and binocular uncorrected and best distance corrected
1 and 3 month postoperatively

Other Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction and spectacle independence
Time Frame: 1 and 3 month postoperatively
1 and 3 month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

November 19, 2012

First Submitted That Met QC Criteria

November 21, 2012

First Posted (Estimate)

November 22, 2012

Study Record Updates

Last Update Posted (Actual)

January 29, 2018

Last Update Submitted That Met QC Criteria

January 25, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 839 MP HEN 402-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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