NCT04299659

Brief Summary

The aim of this study is to investigate and compare the validity of four different input methods for Landolt Cs, i.e. the proportion of correct gap positions in relation to the total number of performances. The four input methods are a numeric keypad, an eight-positions rocker switch, a remote control and voice feedback.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
2.4 years until next milestone

Study Start

First participant enrolled

July 22, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

March 1, 2020

Last Update Submit

July 19, 2023

Conditions

Keywords

psychophysicsvisual acuityresponseresponse entryvalidityretest reliabilityreproducibilityevaluationoptotypeLandolt C

Outcome Measures

Primary Outcomes (1)

  • validity

    Proportion of correct gap position entries in relation to the total number of LC presentations by the four different entry methods

    Through study completion, an average of 3 months

Secondary Outcomes (3)

  • retest reliability

    Through study completion, an average of 3 months

  • Examination duration

    Through study completion, an average of 3 months

  • Subjects´ satisfaction

    Through study completion, an average of 3 months

Interventions

Landolt C entry methodDIAGNOSTIC_TEST

Four different methods for entering the Landolt C gap position are compared

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy, young subjects recruited for the students and or co-workers of the Aalen University of Applied Sciences

You may qualify if:

  • Age: ≥ 18 years
  • Informed consent
  • (Distance) visual acuity with best correction: ≥ 0.8
  • (Distant) ametropia: ≤+8.0 Diopters (spherical equivalent)
  • Anisometropia ≤ 3 dpt
  • Astigmatism ≤ 2.5 dpt

You may not qualify if:

  • Prolonged reaction time caused by drugs (medications)/ drugs/alcohol
  • Movement disorders (of hands) such as Parkinson's disease
  • Indication of amblyopia (strabismus surgery, occlusion therapy etc.)
  • Eye movement disorders/double vision
  • Defective stereo vision (according to LANG \[I\] stereo test)
  • Presence of a relative afferent pupil defect ("swinging flashlight test)
  • Any hint of visual pathway lesion or other chronic or progressive eye disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulrich SCHIEFER

Aalen, Deutschland, 73430, Germany

Location

Study Officials

  • Ulrich Schiefer, M.D.

    +49 7361 576-4605

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2020

First Posted

March 9, 2020

Study Start

July 22, 2022

Primary Completion

March 1, 2023

Study Completion

June 30, 2023

Last Updated

July 20, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations