NCT03223857

Brief Summary

To evaluate the visual performance after bilateral implantation of multifocal intraocular lenses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2013

Longer than P75 for all trials

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

April 9, 2013

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2019

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

5.7 years

First QC Date

July 18, 2017

Last Update Submit

March 22, 2019

Conditions

Visual Acuity

Keywords

visual outcomesmultifocal intraocular lenspatient satisfactionspectacle independence

Outcome Measures

Primary Outcomes (1)

  • Best corrected visual acuity at intermediate distance

    Monocular and binocular corrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery

    Measured 3 month after lens surgery

Secondary Outcomes (7)

  • Best corrected visual acuity at far distance

    Measured 3 month after lens surgery

  • Best corrected visual acuity at near distance

    Measured 3 month after lens surgery

  • Uncorrected visual acuity at far distance

    Measured 3 month after lens surgery

  • Uncorrected visual acuity at intermediate distance

    Measured 3 month after lens surgery

  • Uncorrected visual acuity at near distance

    Measured 3 month after lens surgery

  • +2 more secondary outcomes

Interventions

Femtosecond-laser-assisted lens exchangePROCEDURE

Bilateral implantation of multifocal intraocular lens (MIOL) following femtosecond-laser-assisted lens exchange

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who received bilateral cataract surgery or refractive lens exchange with the implantation of a multifocal intraocular lens

You may qualify if:

  • bilateral cataract surgery or refractive lens exchange with the implantation a multifocal intraocular lens
  • a regular corneal astigmatism \< 1.5 D measured with Pentacam (Oculus, Wetzlar, Germany)

You may not qualify if:

  • other previous ocular surgeries
  • ocular pathologies
  • corneal abnormalities
  • endothelial cell count below 2000/mm²

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of ophthalmology University clinic Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Thomas Kohnen, Professor

    Goethe University Clinic Frankfurt

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr. med. Thomas Kohnen

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 21, 2017

Study Start

April 9, 2013

Primary Completion

December 23, 2018

Study Completion

March 23, 2019

Last Updated

March 25, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)