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Completed

NCT Number: NCT04299659

Comparison of Four Methods for Entering the Gap Position of Landolt Cs

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ulrich SCHIEFER

Aalen, Deutschland, 73430, Germany

About this study

The measurement of visual acuity is the most frequent and one of the most important ophthalmological functional investigations. Therefore, it is particularly important to find a measuring procedure with as little input errors as possible.

The 8-position Landolt C (LC) is the internationally accepted, well-standardised optotype for the determination of visual acuity.

Usually, the subjects informs the examiner verbally about the perceived position of each LC. According to the current literature, about 20 to 30 % of the population suffers from a right/left weakness. Furthermore, language barriers are an additional considerable hurdle.

Therefore, it is important to find an input method for the LC gap positions with minimal entry mistakes. In oder to avoid the thresholding procedure and its inherent difficulties, highly supra-threshold (10 times above the previously determined individual central visual acuity threshold) 8-position LCs are presented.

The study compares four input methods for entering of the Landolt C gap positions: a modified numeric keypad, an 8-position rocker switch, a modified TV remote control and voice/verbal feedback.

Each subject will perform all four input methods, with 2 test runs of 16 Landolt C presentations, each. A forced-choice method will be applied, i.e. the test is not continued until the test person has responded ot each single presentation. Regardless of whether the entry was correct or incorrect, the next Landolt C is displayed.

The optotypes are presented using modified version of the Freiburg Visual Acuity and Contrast Test (FrACT), which allows to present the 8-position Landolt Cs in a standardized way on a video display unit (VDU).

The sequence of the input methods is randomized. This study is carried out in a "within-subject design", i.e. all test persons go through all test conditions and serve as their own controls.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Landolt C entry method

Diagnostic Test

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

Primary outcomes

  1. validity

    Time frame: Through study completion, an average of 3 months

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

Secondary outcomes

  1. retest reliability

    Time frame: Through study completion, an average of 3 months

    Comparison of the correct gap position entry between first and second test run by the four different entry methods

  2. Examination duration

    Time frame: Through study completion, an average of 3 months

    Comparison of the examination duration of the the four different entry methods and by the first and second run

  3. Subjects´ satisfaction

    Time frame: Through study completion, an average of 3 months

    Subjects´ evaluation (using a questionnaire) for the four different entry methods

Sponsors and collaborators

Lead sponsor

Aalen University

Other

Registry information

Official study title

Comparison of Four Methods for Entering the Gap Position of Landolt Cs With Respect to Validity, Retest Reliability, Examination Duration and Test Subject Satisfaction

Acronym: LC_Entry

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 9, 2020
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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