Project Bidof - Monovision by Pairing Bifocal and EDOF Lens

Sponsor
Johannes Kepler University of Linz (Other)
Overall Status
Recruiting
CT.gov ID
NCT05303571
Collaborator
(none)
52
1
12
4.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    52 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Project Bidof - Achieving Hybrid Monovision by Pairing Bifocal and EDOF Lens Technology
    Actual Study Start Date :
    Mar 14, 2022
    Anticipated Primary Completion Date :
    Mar 14, 2023
    Anticipated Study Completion Date :
    Mar 14, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Monodof

    monofocal and EDOF lens

    Bidof

    Bifocal and EDOF lens

    Outcome Measures

    Primary Outcome Measures

    1. Distance Visual Acuity [6 months]

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

    2. Intermediate Visual Acuity [6 months]

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

    3. Near Visual Acuity [6 months]

      percentage of patients with binocular near visual acuity logmar < 0.2

    Secondary Outcome Measures

    1. contrast vision [3 months]

      contrast sensitivity vision

    2. Halo and Glare [3 months]

      Halo and Glare Simulator

    3. Defocus curve [3 and 6 months]

      Defocus curve

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johannes Kepler University Linz Upper Austria Austria 4020

    Sponsors and Collaborators

    • Johannes Kepler University of Linz

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Matthias Bolz, Head of Ophtalmology, Johannes Kepler University of Linz
    ClinicalTrials.gov Identifier:
    NCT05303571
    Other Study ID Numbers:
    • KUK-Ophthalmology-005
    First Posted:
    Mar 31, 2022
    Last Update Posted:
    Apr 27, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 27, 2022