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
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
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
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
NCT ID
NCT04597255
First Posted
October 15, 2020
Last Updated
October 15, 2020
Sponsor
Medical University of Vienna
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
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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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