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

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: AT LISA tri 839MP

• Registration Number: NCT01731743
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-11-19
• Study First Submitted QC: 2012-11-21
• Study First Posted: 2012-11-22
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-25
• Last Update Posted: 2018-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
implantation of a trifocal IOL (AT LISA tri 839MP)	AT LISA tri 839MP	-

Primary Outcome Measures

Name	Time	Method
Intermediate visual acuity	up to 3 months postoperatively	Monocular and binocular uncorrected and best distance corrected

Secondary Outcome Measures

Name	Time	Method
near and far visual acuity	1 and 3 month postoperatively	Monocular and binocular uncorrected and best distance corrected

Trial Locations

Locations (1)

Carl Zeiss Meditec AG; 🇩🇪 Berlin, Germany