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Digital Wavefront Sensing (DWS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04597255
Recruitment Status : Not yet recruiting
First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Information provided by (Responsible Party):
Doreen Schmidl, Medical University of Vienna

Brief Summary:
A holographic optical coherence tomography (H-OCT) setup is used to detect the wavefront by means of phase reconstruction.

Condition or disease Intervention/treatment Phase
Wavefront Aberration, Corneal Refractive Errors Device: Holographic optical coherence tomography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Reproducibility and Comparison of Digital Wavefront Sensing With Conventional Shack-Hartmann Wavefront Sensing: an Explorative Study
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Holographic optical coherence tomography
Healthy phakic participants
Device: Holographic optical coherence tomography
Descriptive wavefront analysis with holographic optical coherence tomography
Other Names:
  • Digital wavefront sensing
  • Digital aberrometry

Primary Outcome Measures :
  1. Qualitative description of lower order aberrations (LOA) [ Time Frame: 14 +/- 3 days ]
    Zernike terms, RMS-error, Strehl ratio

  2. Qualitative description of higher order aberrations (HOA) [ Time Frame: 14 +/- 3 days ]

    Zernike terms, root mean square error

    , Strehl ratio

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04597255

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Contact: Doreen Schmidl, MD, PhD 40400 ext 1988

Sponsors and Collaborators
Medical University of Vienna
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Principal Investigator: Rainer Leitgeb, Prof. Meidcal University of Vienna
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Responsible Party: Doreen Schmidl, Doreen Schmidl [dschmidl], Medical University of Vienna Identifier: NCT04597255    
Other Study ID Numbers: OPHT-100419
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Doreen Schmidl, Medical University of Vienna:
digital wavefront sensing
optical coherence tomography
Additional relevant MeSH terms:
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Refractive Errors
Corneal Wavefront Aberration
Eye Diseases
Corneal Diseases