NCT01731743

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

January 29, 2018

Status Verified

January 1, 2018

Enrollment Period

1.5 years

First QC Date

November 19, 2012

Last Update Submit

January 25, 2018

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Intermediate visual acuity

    Monocular and binocular uncorrected and best distance corrected

    up to 3 months postoperatively

Secondary Outcomes (1)

  • near and far visual acuity

    1 and 3 month postoperatively

Other Outcomes (1)

  • Patient satisfaction and spectacle independence

    1 and 3 month postoperatively

Study Arms (1)

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

OTHER
Device: AT LISA tri 839MP

Interventions

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

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Man or woman, over 50 years of age
  • Bilateral implantation of a trifocal intraocular lens
  • Capsular bag implantation

You may not qualify if:

  • Existing ocular pathology
  • Surgical complications
  • Corneal astigmatism ≥ 1.0D

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carl Zeiss Meditec AG

Berlin, 10589, Germany

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2012

First Posted

November 22, 2012

Study Start

January 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

January 29, 2018

Record last verified: 2018-01

Locations

DE(1)