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Clinical Trials/NCT05303571
NCT05303571
Withdrawn
Not Applicable

Project Bidof - Achieving Hybrid Monovision by Pairing Bifocal and EDOF Lens Technology

Johannes Kepler University of Linz1 site in 1 countryMarch 14, 2022
ConditionsCataract Senile

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract Senile
Sponsor
Johannes Kepler University of Linz
Locations
1
Primary Endpoint
Distance Visual Acuity
Status
Withdrawn
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 14, 2022
End Date
March 14, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Johannes Kepler University of Linz
Responsible Party
Principal Investigator
Principal Investigator

Matthias Bolz

Head of Ophtalmology

Johannes Kepler University of Linz

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Distance Visual Acuity

Time Frame: 6 months

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

Intermediate Visual Acuity

Time Frame: 6 months

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

Near Visual Acuity

Time Frame: 6 months

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

Secondary Outcomes

  • contrast vision(3 months)
  • Halo and Glare(3 months)
  • Defocus curve(3 and 6 months)

Study Sites (1)

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