NCT05303571

Brief Summary

Modern day cataract surgery isn't just a rehabilitative procedure anymore but rather aims at improving a patient's quality of life by reducing the need for spectacles in everyday life to a minimum. One way of achieving this goal is by using different lens technologies, such as a mono- or bifocal lens paired a lens with EDOF technology, as EDOF lenses provide an enhanced depth of focus by creating a single elongated focal point. As this method is well established, the aim of this study is to compare the monofocal/EDOF cohort to the bifocal/EDOF cohort and evaluate visual acuity and patient satisfaction for both combinations.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

March 14, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2023

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

March 22, 2022

Last Update Submit

March 5, 2024

Conditions

Cataract Senile

Outcome Measures

Primary Outcomes (3)

  • Distance Visual Acuity

    percentage of patients with binocular distance corrected visual acuity of logMAR \> 0.2

    6 months

  • Intermediate Visual Acuity

    percentage of patients with binocular intermediate distance corrected visual acuity of logMAR \> 0.2

    6 months

  • Near Visual Acuity

    percentage of patients with binocular near visual acuity logmar \< 0.2

    6 months

Secondary Outcomes (3)

  • contrast vision

    3 months

  • Halo and Glare

    3 months

  • Defocus curve

    3 and 6 months

Study Arms (2)

Monodof

monofocal and EDOF lens

Bidof

Bifocal and EDOF lens

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient between 21 and 99 years after cataract surgery

You may qualify if:

  • Age between 21 and 99 years
  • signed informed consent form
  • condition after cataract surgery

You may not qualify if:

  • no signed informed consent form
  • laser treatment of the Cornea
  • macular pathologies
  • corneal pathologies
  • irregular astigmatism
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johannes Kepler University

Linz, Upper Austria, 4020, Austria

Location
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Ophtalmology

Study Record Dates

First Submitted

March 22, 2022

First Posted

March 31, 2022

Study Start

March 14, 2022

Primary Completion

March 14, 2023

Study Completion

March 14, 2023

Last Updated

March 7, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)