wDDART: Development and Validation of an Internet-based Near and Intermediate-vision Reading Test

Sponsor
Democritus University of Thrace (Other)
Overall Status
Completed
CT.gov ID
NCT04618224
Collaborator
University of Thessaly (Other)
100
2
2.3
50
21.7

Study Details

Study Description

Brief Summary

Primary objective of our study is to develop and validate an internet-based digital near and intermediate-vision reading test in the greek language.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: DDART Testing
  • Diagnostic Test: wDDART Testing

Detailed Description

Present study aims to develop and validate a computer-based digital near-vision reading test (web Democritus Digital Acuity Reading Test - wDDART) based on the validated digital DDART.

Specifically, present study aims to develop a new online reading test (wDDART) based on the corresponding digital DDART reading test for Windows and to evaluate the level of agreement between the two reading tests, as well as test-retest reliability of the online wDDART reading test.

The first part of the study is the development of the online reading test, which will include the following new smart features:

  1. Automatic calculation of the reading time of each sentence (each logMAR)

  2. Automatic calculation of the basic reading parameters - RA, MRS, CPS, ACC - immediately after the completion of the examination

  3. Adjustment of the font size according to the size of the computer screen used for the examination

  4. Real time calculation of the patient-screen distance through a face detection system

The second part of this study is the clinical validation of the online wDDART reading test. In this part, four reading parameters measured with the digital and the online version are compared. These parameters are the following:

  1. Reading Acuity (RA)

  2. Maximum Reading Speed (MRS)

  3. Critical Print Size (CPS)

  4. Accessibility Index (ACC) All the comparisons take place in two groups: a) a Normal Vision Group (NVG), and b) a Low Vision Group (LVG) in order to estimate the reading capacity in a population with a wide range of vision.

Study Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Introduction of an Internet-based Near and Intermediate-vision Reading Test for Greek-speaking Normal and Low Vision Adults (wDDART): Development and Validation.
Actual Study Start Date :
Dec 2, 2020
Actual Primary Completion Date :
Jan 15, 2021
Actual Study Completion Date :
Feb 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Control group

70 patients with normal vision (NVG) with adequate literacy of written Greek language 30 patients with low vision (LVG) with adequate literacy of written Greek language These patients are tested on the digital reading test DDART.

Diagnostic Test: DDART Testing
One randomly selected eye is included for each study participant. Participants respond to the DDART near vision test with defined environmental conditions at 40 cm viewing distance. All four parameters (RA, MRS, CPS and ACC) are evaluated.

Study group

The same patients as those in the control group (NVG, LVG) are tested on the online version of the Greek digital reading test DDART (wDDART).

Diagnostic Test: wDDART Testing
One randomly selected eye is included for each study participant. Participants respond to the wDDART near vision test with defined environmental conditions at 40 cm viewing distance. All four parameters (RA, MRS, CPS and ACC) are evaluated.

Outcome Measures

Primary Outcome Measures

  1. Reading Acuity (RA) [through study completion, an average of 3 months]

    The smallest print that can be read by the patient easily (measured in logMAR). It is calculated by the following formula: RA = 1.4 - (sentences x 0.1) + (errors x 0.01).

  2. Maximum Reading Speed (MRS) [through study completion, an average of 3 months]

    The patient's reading speed (measured in wpm) when reading is not limited by print size. It is calculated by averaging the reading speed of the sentences with print size larger than the CPS.

  3. Critical Print Size (CPS) [through study completion, an average of 3 months]

    The smallest print size (measured in logMAR) that can be read with the MRS, i.e., with speed greater than or equal to the average reading speed of the larger logMAR print sentences minus 1.96 times the standard deviation (SD) of the reading speed of these sentences.

  4. Accessibility Index (ACC) [through study completion, an average of 3 months]

    The mean reading speed of the 10 largest print sizes at 40 cm (1.3 to 0.4 logMAR), divided by 200 wpm, which is the mean reading speed of normally sighted young adults aged 18 to 39 years old. This parameter was designed for better evaluation of one's access to text across the range of the 10 most common print sizes found in everyday life. For instance, a value of 0 means no access to commonly encountered printed material, while 1.0 is the mean value for normally sighted young adults that indicates reading fluency within the everyday life print sizes.

Secondary Outcome Measures

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

    Level of agreement between the digital and the online version are evaluated by calculation of the ICCs for the 4 reading parameters (RA, MRS, CPS, ACC).

Other Outcome Measures

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

    Test-retest reliability of the internet-based reading test wDDART is evaluated by ICCs for the 4 reading parameters (RA, MRS, CPS, ACC).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Adequate literacy of written Greek language

  • Age between 18 to 75 years

Exclusion Criteria:
  • Dyslexia

  • Attention-deficiency

  • Former diagnosis of mental and/or psychiatric diseases

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Ophthalmology, University Hospital of Alexandroupolis Alexandroupolis Evros Greece 68100
2 Department of Computer Science and Biomedical Informatics, University of Thessaly Lamía Thessaly Greece 35100

Sponsors and Collaborators

  • Democritus University of Thrace
  • University of Thessaly

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:
NCT04618224
Other Study ID Numbers:
  • ES13/Th29/22-10-2020
First Posted:
Nov 5, 2020
Last Update Posted:
Feb 16, 2021
Last Verified:
Feb 1, 2021
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2021