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

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
AT LISA tri 839MP
Sponsored by
Carl Zeiss Meditec AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Carl Zeiss Meditec AG

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

implantation of a trifocal IOL (AT LISA tri 839MP)

Arm Description

Outcomes

Primary Outcome Measures

Intermediate visual acuity
Monocular and binocular uncorrected and best distance corrected

Secondary Outcome Measures

near and far visual acuity
Monocular and binocular uncorrected and best distance corrected

Full Information

First Posted
November 19, 2012
Last Updated
January 25, 2018
Sponsor
Carl Zeiss Meditec AG
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1. Study Identification

Unique Protocol Identification Number
NCT01731743
Brief Title
Evaluation of Visual Acuity and Patient Satisfaction With AT LISA TRI 839MP Intraocular Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carl Zeiss Meditec AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
implantation of a trifocal IOL (AT LISA tri 839MP)
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
AT LISA tri 839MP
Primary Outcome Measure Information:
Title
Intermediate visual acuity
Description
Monocular and binocular uncorrected and best distance corrected
Time Frame
up to 3 months postoperatively
Secondary Outcome Measure Information:
Title
near and far visual acuity
Description
Monocular and binocular uncorrected and best distance corrected
Time Frame
1 and 3 month postoperatively
Other Pre-specified Outcome Measures:
Title
Patient satisfaction and spectacle independence
Time Frame
1 and 3 month postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Carl Zeiss Meditec AG
City
Berlin
ZIP/Postal Code
10589
Country
Germany

12. IPD Sharing Statement

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

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