A New Parameter for the Assessment of Distance Visual Capacity: the Critical Visual Acuity (CVA)

Sponsor
Democritus University of Thrace (Other)
Overall Status
Recruiting
CT.gov ID
NCT04632901
Collaborator
(none)
300
1
5
59.7

Study Details

Study Description

Brief Summary

The conventional examination of the visual acuity (VA) does not take into account the patient's reading speed. However, the consideration of the speed for the recognition of the VA charts' symbols leads to the more accurate and comprehensive assessment of the visual capacity.

Therefore, primary objective of this study is to develop and validate a new parameter for the more comprehensive evaluation of visual capacity: the critical visual acuity (CVA). CVA takes into account the speed of recognition of the symbols of the distance visual charts.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: VA assessment
  • Diagnostic Test: CVA assessment

Detailed Description

In clinical practice, the conventional examination of the VA does not take into account the patient's reading speed, and does not reflect the requirements of everyday life (e.g. driving, watching subtitles on TV), in which each individual has limited time to react. In addition, the VA measured with the conventional method differs significantly among the different examiners, since there is no standard time limit for the patient to read the chart symbols.

However, the consideration of the speed for the recognition of the VA charts' symbols leads to the more accurate and comprehensive assessment of the visual capacity. Therefore, primary objective of this study is to develop and validate a new parameter for the more comprehensive evaluation of visual capacity: the critical visual acuity (CVA), and to determine normal values of population according to age. CVA takes into account the speed of recognition of the symbols of the distance visual charts.

Participants are recruited from the outpatient service of the Department of Ophthalmology of the University Hospital of Alexandroupolis in a consecutive-if-eligible basis. At first, each participant performs the conventional VA test monocularly. Then, he/she performs the CVA test with the same eye. Two different printed Landolt ring charts are used, the first one for VA and the second one for CVA assessment for all participants to avoid memorization. The VA and CVA are evaluated for all participants under the same environmental lighting conditions.

Regarding the VA and CVA examination procedure, the investigator masks the chart lines using a blank piece of paper and reveals one line each time. The investigator instructs the patient to read aloud the 5 letters of the Landolt chart, as quickly and accurately as possible, after hearing the words "Ready!… Go!". At the same time, a second examiner starts a stopwatch to record the reading time (in seconds, to the nearest 0.01 s) when the examiner fully reveals the line and the patient starts to read it. The first examiner counts the number of errors for each line and the second one enters the reading time for each line in a data file. The reading time of each line is compared with the automatically calculated average reading time of the larger lines minus 1.96 (for CVA) or 2.58 (for VA) times the standard deviation (SD) of the reading time of these lines.

Testing stops when the letters are too small for the examinee to discriminate and/or they are read with a speed lower than the maximum reading speed (MRS) of each examinee.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Development and Validation of a New Parameter for the Assessment of Distance Visual Capacity: the Critical Visual Acuity (CVA)
Actual Study Start Date :
Sep 20, 2020
Anticipated Primary Completion Date :
Jan 20, 2021
Anticipated Study Completion Date :
Feb 20, 2021

Arms and Interventions

Arm Intervention/Treatment
Testing of Visual Acuity (VA) Group

The same participants will undergo VA and CVA test with two different Landolt C charts under the same lighting conditions.

Diagnostic Test: VA assessment
The VA of all participants will be evaluated by counting the smallest line that can be read within a time duration greater than or equal to the average reading time of the larger lines minus 2.58 times the SD of the reading time of these lines. In clinical practice, the VA is the common parameter of VA adding a tolerant time limit to clearly determine the end of the test.

Testing of Critical Visual Acuity (CVA) Group

The same participants will undergo VA and CVA test with two different Landolt C charts under the same lighting conditions.

Diagnostic Test: CVA assessment
The CVA of all participants will be evaluated by counting the smallest line that can be read within a time duration greater than or equal to the average reading time of the larger lines minus 1.96 times the SD of the reading time of these lines. In clinical practice, the CVA is the minimum VA that can be read in maximal speed.

Outcome Measures

Primary Outcome Measures

  1. Critical Visual Acuity (CVA) [6 months]

    The smallest line (measured in letters) that can be read with the maximum reading speed, i.e., with speed greater than or equal to the average reading speed of the larger lines minus 1.96 times the standard deviation (SD) of the reading speed of these lines. In clinical practice, the CVA is the minimum VA that can be read in maximal speed.

  2. Visual Acuity (VA) [6 months]

    The smallest line (measured in letters) that can be read with speed greater than or equal to the average reading speed of the larger lines minus 2.58 times the standard deviation (SD) of the reading speed of these lines. In clinical practice, the VA is the common parameter of VA adding a tolerant time limit to clearly determine the end of the test.

Secondary Outcome Measures

  1. Intraclass Correlation Coefficients (ICCs) for study participants [through study completion, an average of 3 months]

    Level of agreement between CVA and VA are evaluated by calculation of the ICCs for these 2 parameters.

Other Outcome Measures

  1. Test-retest Intraclass Correlation Coefficients (ICCs) [through study completion, an average of 3 months]

    Test-retest reliability of the CVA test is evaluated by ICCs for the CVA parameter within 15 days

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • People aged 18 - 75 years
Exclusion Criteria:
  • neurological diseases

  • mental diseases

  • mental retardation,

  • difficulty reading

  • previous intraocular surgery

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Ophthalmology, University Hospital of Alexandroupolis Alexandroupolis Evros Greece 68100

Sponsors and Collaborators

  • Democritus University of Thrace

Investigators

  • Study Chair: Georgios Labiris, MD, PhD, Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Georgios Labiris, Professor (Associate) of Democritus University of Thrace, Democritus University of Thrace
ClinicalTrials.gov Identifier:
NCT04632901
Other Study ID Numbers:
  • ES12/Th3/17-9-2020
First Posted:
Nov 17, 2020
Last Update Posted:
Nov 17, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Georgios Labiris, Professor (Associate) of Democritus University of Thrace, Democritus University of Thrace

Study Results

No Results Posted as of Nov 17, 2020