Wavefront Aberration, CornealDWSNCT04597255
Digital Wavefront Sensing
A study testing Holographic optical coherence tomography in people with Wavefront Aberration, Corneal and Refractive Errors, run by Medical University of Vienna.
Trial summary
A holographic optical coherence tomography (H-OCT) setup is used to detect the wavefront by means of phase reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Wavefront Aberration, Corneal, Refractive Errors
- What is being tested?
- Holographic optical coherence tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Reproducibility and Comparison of Digital Wavefront Sensing With Conventional Shack-Hartmann Wavefront Sensing: an Explorative Study
A holographic optical coherence tomography (H-OCT) setup is used to detect the wavefront by means of phase reconstruction.
Read the 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.
- Conditions
- Wavefront Aberration, Corneal, Refractive Errors
- Being tested
- Holographic optical coherence tomography
- Keywords
- digital wavefront sensing, optical coherence tomography
- Medical subject headings
- Corneal Wavefront Aberration, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holographic optical coherence tomographyDevice
Also called Digital wavefront sensing, Digital aberrometry
Descriptive wavefront analysis with holographic optical coherence tomography
| Study group | Role | What they receive |
|---|---|---|
| Holographic optical coherence tomography | Experimental | Healthy phakic participants Receives: Device: Holographic optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative description of lower order aberrations (LOA)
Zernike terms, RMS-error, Strehl ratio
Measured: 14 +/- 3 days
Qualitative description of higher order aberrations (HOA)
Zernike terms, root mean square error
, Strehl ratio
Measured: 14 +/- 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study startDec 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Wavefront Aberration, CornealStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doreen Schmidl, Medical University of Vienna
- Investigators
- Rainer Leitgeb, Prof., Principal investigator, Meidcal University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597255
- Sponsor's protocol ID
- OPHT-100419
- Acronym
- DWS
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23669942Liang 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.
PubMed 8071736Kumar 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.
PubMed 28717573
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility and Comparison of Digital Wavefront Sensing With Conventional Shack-Hartmann Wavefront Sensing: an Explorative Study
- ClinicalTrials.gov ID
- NCT04597255
- Acronym / sponsor ID
- DWS / OPHT-100419
- Conditions
- Wavefront Aberration, Corneal, Refractive Errors
- Keywords
- digital wavefront sensing, optical coherence tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Holographic optical coherence tomography | Experimental | Device: Holographic optical coherence tomographyHealthy phakic participants |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holographic optical coherence tomographyAlso: Digital wavefront sensing, Digital aberrometryDescriptive wavefront analysis with holographic optical coherence tomography | Device | Holographic optical coherence tomography |
Primary outcome
Qualitative description of lower order aberrations (LOA)
Time frame: 14 +/- 3 days
Zernike terms, RMS-error, Strehl ratio
Qualitative description of higher order aberrations (HOA)
Time frame: 14 +/- 3 days
Zernike terms, root mean square error , Strehl ratio
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Background: PubMed 23669942Kumar 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.
- Background: PubMed 8071736Liang 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.
- Background: PubMed 28717573Kumar 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.
- Individual participant dataSharing planned: Undecided
Related trials for Wavefront Aberration, Corneal
Not yet recruiting
Factors Influencing Subjective Visual Quality in Human Eyes
Corneal Wavefront Aberration, Refractive Errors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer Leitgeb, Prof. principal investigator
Meidcal University of Vienna
Questions about this trial
What is this clinical trial studying?
A study testing Holographic optical coherence tomography in people with Wavefront Aberration, Corneal and Refractive Errors, run by Medical University of Vienna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doreen Schmidl, MD, PhD (40400 ext. 1988, klin-pharmakologie@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative description of lower order aberrations (LOA) (time frame: 14 +/- 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04597255, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.