NCT03452969

Brief Summary

To evaluate visual outcomes of a segmental refractive multifocal intraocular lens (IOL) after cataract surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2014

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2014

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

October 10, 2018

Status Verified

October 1, 2018

Enrollment Period

3.7 years

First QC Date

February 26, 2018

Last Update Submit

October 9, 2018

Conditions

Visual Acuity

Keywords

visual outcomesmulitfocal intraocular lenspatient satisfactionspectacle independencecontrast sensitivity

Outcome Measures

Primary Outcomes (1)

  • Best corrected visual acuity at far distance

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

    Measured 3 month after lens surgery

Secondary Outcomes (9)

  • Best corrected visual acuity at intermediate 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

  • +4 more secondary outcomes

Interventions

Implantation of multifocal intraocular lensOTHER

Procedure/Surgery: Bilateral implantation of a segmental refractive multifocal intraocular lens (MIOL) following cataract surgery.

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • bilateral cataract
  • age \> 45 years
  • corneal astigmatism ≤ 0.75 D postoperatively
  • pupil size 3 to 6 mm (mesopic)
  • center shift \< 1 mm

You may not qualify if:

  • previous ocular surgeries
  • amblyopia
  • potential postoperative distance-corrected visual acuity (DCVA) \< 0.3 logMAR

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr. med. Thomas Kohnen

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 2, 2018

Study Start

August 28, 2014

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

October 10, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)