- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04642495
Objective Visual Acuity Measurement Using Suppression of the Optokinetic Nystagmus (OKN). (Speedwheel)
May 6, 2021 updated by: Anja Palmowski-Wolfe, University of Basel
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
246
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Basel, Switzerland, 4031
- University Basel, University Eye Hospital Basel
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
healthy volunteers aged 4 and above
Description
Inclusion Criteria:
- able and willing to perform the test
Exclusion Criteria:
- under 4 years of age
- unable or unwilling
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Human subjects aged 4 and above
Human volunteers aged 4 and above.
|
Establish prediction intervals for acuity tests
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prediction intervals of Snellen acuity for Landolt C compared to E symbols
Time Frame: 12 months
|
Prediction intervals of Snellen acuity for Landolt C compared to E symbols
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anja M Palmowski-Wolfe, Prof, University Basel, University Eye Hospital Basel
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Schwob 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.
- Luethy 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Actual)
July 30, 2020
Study Completion (Actual)
September 30, 2020
Study Registration Dates
First Submitted
November 17, 2020
First Submitted That Met QC Criteria
November 18, 2020
First Posted (Actual)
November 24, 2020
Study Record Updates
Last Update Posted (Actual)
May 10, 2021
Last Update Submitted That Met QC Criteria
May 6, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-02078
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The results are to be shared in a publication
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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