Evaluation of Visual Acuity and Patient Satisfaction With... | NCT01731743

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

NCT01731743

Sponsor

Carl Zeiss Meditec AG

Status

Completed

Last Update Posted

Jan 29, 2018Actual

Enrollment

107Actual

Phase

Not Applicable

Conditions

Cataract

Interventions

AT LISA tri 839MP

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Nov 19, 2012

First Submission Date that Met QC Criteria

Nov 21, 2012

First Posted Date

Nov 22, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2018

Last Update Posted Date

Jan 29, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

107Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
implantation of a trifocal IOL (AT LISA tri 839MP)	Other		Device: AT LISA tri 839MP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AT LISA tri 839MP	Device		implantation of a trifocal IOL (AT LISA tri 839MP)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carl Zeiss Meditec AG		Berlin		10589	Germany

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided