Visual AcuitySpeedwheelNCT04642495
Objective Visual Acuity Measurement Using Suppression of the Optokinetic Nystagmus (OKN).
An observational study of Visual Acuity, run by University of Basel at 1 site in Switzerland.
Trial summary
Suppression of the optokinetic nystagmus when a target is perceived can be applied to assess visual acuity objectively. Our aim is to establish prediction intervals for this optokinetic nystagmus suppression test (Speedwheel Test, SW) so that SW acuity may be used to estimate Snellen acuity (FrACT- C and -E) in the… Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- Visual acuity testing with SW , Landolt-"C" and Tumbling-"E" symbols
- How many people
- 246 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2019to 30 Sep 2020
- Phase
- Observational
- 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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: healthy volunteers aged 4 and above
Who may be able to join
- able and willing to perform the test
Who cannot join
- under 4 years of age
- unable or unwilling
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Basel, University Eye Hospital Basel
Basel, 4031
About this study
Official title: Clinical Application of Objective Visual Acuity Measurement Using Suppression Method to Inhibit Optokinetic Nystagmus (OKN).
Suppression of the optokinetic nystagmus when a target is perceived can be applied to assess visual acuity objectively. Our aim is to establish prediction intervals for this optokinetic nystagmus suppression test (Speedwheel Test, SW) so that SW acuity may be used to estimate Snellen acuity (FrACT- C and -E) in the clinic in adults and children unable to cooperate in other acuity testing.
Read the detailed description
In this prospective single center study subjects aged at least 4 years underwent testing of visual acuity with SW, Landolt-C and Tumbling-E symbols (Freiburg acuity test: FrACT-C, FrACT-E). Prediction intervals are to be established for SW compared to FrACT-C or -E and for FrACT- E compared to FrACT-C.
- Conditions
- Visual Acuity
- Being tested
- Visual acuity testing with SW , Landolt-"C" and Tumbling-"E" symbols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual acuity testing with SW , Landolt-"C" and Tumbling-"E" symbolsDiagnostic test
Establish prediction intervals for acuity tests
| Study group | Role | What they receive |
|---|---|---|
| Human subjects aged 4 and above | Human volunteers aged 4 and above. Receives: Diagnostic Test: Visual acuity testing with SW , Landolt-"C" and Tumbling-"E" symbols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction intervals of Snellen acuity for the SW
Prediction intervals of Snellen acuity for the SW compared to Landolt C and E symbols
Measured: 12 months
Secondary outcomes (1)
Prediction intervals of Snellen acuity for Landolt C compared to E symbols
Prediction intervals of Snellen acuity for Landolt C compared to E symbols
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start1 Oct 2019
- Primary completion30 Jul 2020
- Study completion30 Sep 2020
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 Visual AcuityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anja Palmowski-Wolfe, University of Basel
- Investigators
- Anja M Palmowski-Wolfe, Prof, Principal investigator, University Basel, University Eye Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642495
- Sponsor's protocol ID
- 2016-02078
- Other IDs
- 2016
- Acronym
- Speedwheel
- Status last verified
- May 2021
- First submitted
- 17 Nov 2020
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results are to be shared in a publication
Publications
Schwob N, Palmowski-Wolfe A. Objective measurement of visual acuity by optokinetic nystagmus suppression in children and adult patients. J AAPOS. 2019 Oct;23(5):272.e1-272.e6. doi: 10.1016/j.jaapos.2019.05.016. Epub 2019 Sep 14.
PubMed 31526857Schwob N, Palmowski-Wolfe A. Establishing an Objective Measurement of Visual Acuity with a Computerised Optokinetic Nystagmus Suppression Test. Klin Monbl Augenheilkd. 2020 Apr;237(4):502-505. doi: 10.1055/a-1119-6123. Epub 2020 Apr 24.
PubMed 32330979Luethy ML, Schotzau A, Palmowski-Wolfe A. Establishing Prediction Intervals for the SpeedWheel Acuity Test in Adults and Children. Klin Monbl Augenheilkd. 2021 Apr;238(4):488-492. doi: 10.1055/a-1403-2218. Epub 2021 Apr 14.
PubMed 33853189
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Objective Visual Acuity Measurement Using Suppression Method to Inhibit Optokinetic Nystagmus (OKN).
- ClinicalTrials.gov ID
- NCT04642495
- Acronym / sponsor ID
- Speedwheel / 2016-02078
- Conditions
- Visual Acuity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 24 Nov 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.
Suppression of the optokinetic nystagmus when a target is perceived can be applied to assess visual acuity objectively. Our aim is to establish prediction intervals for this optokinetic nystagmus suppression test (Speedwheel Test, SW) so that SW acuity may be used to estimate Snellen acuity (FrACT- C and -E) in the clinic in adults and children unable to cooperate in other acuity testing.
Detailed description
In this prospective single center study subjects aged at least 4 years underwent testing of visual acuity with SW, Landolt-C and Tumbling-E symbols (Freiburg acuity test: FrACT-C, FrACT-E). Prediction intervals are to be established for SW compared to FrACT-C or -E and for FrACT- E compared to FrACT-C.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human subjects aged 4 and above | – | Diagnostic Test: Visual acuity testing with SW , Landolt-"C" and Tumbling-"E" symbolsHuman volunteers aged 4 and above. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- healthy volunteers aged 4 and above
Key inclusion criteria (1 listed)
- able and willing to perform the test
Key exclusion criteria (2 listed)
- under 4 years of age
- unable or unwilling
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 |
|---|---|---|
| Visual acuity testing with SW , Landolt-"C" and Tumbling-"E" symbolsEstablish prediction intervals for acuity tests | Diagnostic test | Human subjects aged 4 and above |
Primary outcome
Prediction intervals of Snellen acuity for the SW
Time frame: 12 months
Prediction intervals of Snellen acuity for the SW compared to Landolt C and E symbols
1 secondary outcome
Prediction intervals of Snellen acuity for Landolt C compared to E symbols
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Background: PubMed 31526857Schwob N, Palmowski-Wolfe A. Objective measurement of visual acuity by optokinetic nystagmus suppression in children and adult patients. J AAPOS. 2019 Oct;23(5):272.e1-272.e6. doi: 10.1016/j.jaapos.2019.05.016. Epub 2019 Sep 14.
- Background: PubMed 32330979Schwob N, Palmowski-Wolfe A. Establishing an Objective Measurement of Visual Acuity with a Computerised Optokinetic Nystagmus Suppression Test. Klin Monbl Augenheilkd. 2020 Apr;237(4):502-505. doi: 10.1055/a-1119-6123. Epub 2020 Apr 24.
- Results publication: PubMed 33853189Luethy ML, Schotzau A, Palmowski-Wolfe A. Establishing Prediction Intervals for the SpeedWheel Acuity Test in Adults and Children. Klin Monbl Augenheilkd. 2021 Apr;238(4):488-492. doi: 10.1055/a-1403-2218. Epub 2021 Apr 14.
- Individual participant dataSharing planned: No. The results are to be shared in a publication
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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.
Anja M Palmowski-Wolfe, Prof principal investigator
University Basel, University Eye Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Acuity, run by University of Basel at 1 site in Switzerland.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction intervals of Snellen acuity for the SW (time frame: 12 months). 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 NCT04642495, 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 10 May 2021; AzTrials last refreshed its copy on 6 Nov 2026.