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Digital Wavefront Sensing (DWS)

Primary Purpose

Wavefront Aberration, Corneal, Refractive Errors

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Holographic optical coherence tomography
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Wavefront Aberration, Corneal focused on measuring digital wavefront sensing, optical coherence tomography

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Informed consent
  2. Men and women aged between 18 and 85 years
  3. Normal ophthalmic findings except refractive errors or suspected higher order aberrations
  4. Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

  1. Hyperopia > +6 Dpt. and Myopia < -6 Dpt.
  2. Known ophthalmic diseases such as age related macular degeneration, diabetic retinopathy, glaucoma, retinal detachment or previous ocular trauma and surgeries except cataract extraction
  3. Participation in a clinical trial in the previous 3 weeks
  4. Presence of any abnormalities preventing reliable measurements as judged by the investigator
  5. Pregnancy, planned pregnancy or lactating

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Holographic optical coherence tomography

    Arm Description

    Healthy phakic participants

    Outcomes

    Primary Outcome Measures

    Qualitative description of lower order aberrations (LOA)
    Zernike terms, RMS-error, Strehl ratio
    Qualitative description of higher order aberrations (HOA)
    Zernike terms, root mean square error , Strehl ratio

    Secondary Outcome Measures

    Full Information

    First Posted
    October 15, 2020
    Last Updated
    October 15, 2020
    Sponsor
    Medical University of Vienna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04597255
    Brief Title
    Digital Wavefront Sensing
    Acronym
    DWS
    Official Title
    Reproducibility and Comparison of Digital Wavefront Sensing With Conventional Shack-Hartmann Wavefront Sensing: an Explorative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2020 (Anticipated)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Vienna

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    A holographic optical coherence tomography (H-OCT) setup is used to detect the wavefront by means of phase reconstruction.
    Detailed Description
    H-OCT will be tested in this study for its suitability for the qualitative investigation of aberrometry. We aim to achieve a digital equivalent for wavefront calculation of the widespread analog procedure commonly used with conventional wavefront-aberrometers. The results will be compared with those from a conventional analog wavefront calculation method. In the course of this pilot study, 20 eyes of phakic and 10 eyes of pseudophakic subjects with suspected higher order aberrations will be examined using H-OCT.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wavefront Aberration, Corneal, Refractive Errors
    Keywords
    digital wavefront sensing, optical coherence tomography

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Holographic optical coherence tomography
    Arm Type
    Experimental
    Arm Description
    Healthy phakic participants
    Intervention Type
    Device
    Intervention Name(s)
    Holographic optical coherence tomography
    Other Intervention Name(s)
    Digital wavefront sensing, Digital aberrometry
    Intervention Description
    Descriptive wavefront analysis with holographic optical coherence tomography
    Primary Outcome Measure Information:
    Title
    Qualitative description of lower order aberrations (LOA)
    Description
    Zernike terms, RMS-error, Strehl ratio
    Time Frame
    14 +/- 3 days
    Title
    Qualitative description of higher order aberrations (HOA)
    Description
    Zernike terms, root mean square error , Strehl ratio
    Time Frame
    14 +/- 3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Informed consent Men and women aged between 18 and 85 years Normal ophthalmic findings except refractive errors or suspected higher order aberrations Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant Exclusion Criteria: Hyperopia > +6 Dpt. and Myopia < -6 Dpt. Known ophthalmic diseases such as age related macular degeneration, diabetic retinopathy, glaucoma, retinal detachment or previous ocular trauma and surgeries except cataract extraction Participation in a clinical trial in the previous 3 weeks Presence of any abnormalities preventing reliable measurements as judged by the investigator Pregnancy, planned pregnancy or lactating
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Doreen Schmidl, MD, PhD
    Phone
    40400
    Ext
    1988
    Email
    klin-pharmakologie@meduniwien.ac.at
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rainer Leitgeb, Prof.
    Organizational Affiliation
    Meidcal University of Vienna
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    23669942
    Citation
    Kumar A, Drexler W, Leitgeb RA. Subaperture correlation based digital adaptive optics for full field optical coherence tomography. Opt Express. 2013 May 6;21(9):10850-66. doi: 10.1364/OE.21.010850.
    Results Reference
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    PubMed Identifier
    8071736
    Citation
    Liang J, Grimm B, Goelz S, Bille JF. Objective measurement of wave aberrations of the human eye with the use of a Hartmann-Shack wave-front sensor. J Opt Soc Am A Opt Image Sci Vis. 1994 Jul;11(7):1949-57. doi: 10.1364/josaa.11.001949.
    Results Reference
    background
    PubMed Identifier
    28717573
    Citation
    Kumar A, Wurster LM, Salas M, Ginner L, Drexler W, Leitgeb RA. In-vivo digital wavefront sensing using swept source OCT. Biomed Opt Express. 2017 Jun 21;8(7):3369-3382. doi: 10.1364/BOE.8.003369. eCollection 2017 Jul 1.
    Results Reference
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    Digital Wavefront Sensing

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