NCT04642495

Brief 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 clinic in adults and children unable to cooperate in other acuity testing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
Last Updated

May 10, 2021

Status Verified

May 1, 2021

Enrollment Period

10 months

First QC Date

November 17, 2020

Last Update Submit

May 6, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prediction intervals of Snellen acuity for the SW

    Prediction intervals of Snellen acuity for the SW compared to Landolt C and E symbols

    12 months

Secondary Outcomes (1)

  • Prediction intervals of Snellen acuity for Landolt C compared to E symbols

    12 months

Study Arms (1)

Human subjects aged 4 and above

Human volunteers aged 4 and above.

Diagnostic Test: Visual acuity testing with SW , Landolt-"C" and Tumbling-"E" symbols

Interventions

Establish prediction intervals for acuity tests

Human subjects aged 4 and above

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy volunteers aged 4 and above

You may qualify if:

  • able and willing to perform the test

You may not qualify if:

  • under 4 years of age
  • unable or unwilling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Basel, University Eye Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 31526857BACKGROUND
  • 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.

    PMID: 32330979BACKGROUND
  • 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 Officials

  • Anja M Palmowski-Wolfe, Prof

    University Basel, University Eye Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr. med.

Study Record Dates

First Submitted

November 17, 2020

First Posted

November 24, 2020

Study Start

October 1, 2019

Primary Completion

July 30, 2020

Study Completion

September 30, 2020

Last Updated

May 10, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

The results are to be shared in a publication

Locations