Evaluation of Visual Acuity and Patient Satisfaction With AT LISA TRI 839MP Intraocular Lenses
The purpose of the study is to evaluate the far, intermediate and near visual acuities with a trifocal IOL.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- Intermediate visual acuity [ Time Frame: up to 3 months postoperatively ] [ Designated as safety issue: No ]Monocular and binocular uncorrected and best distance corrected
- 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
- Patient satisfaction and spectacle independence [ Time Frame: 1 and 3 month postoperatively ] [ Designated as safety issue: No ]
|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)|
|implantation of a trifocal IOL (AT LISA tri 839MP)||Device: AT LISA tri 839MP|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731743
|Carl Zeiss Meditec AG|
|Berlin, Germany, 10589|