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

February 12, 2021 updated by: Georgios Labiris, Democritus University of Thrace

Introduction of an Internet-based Near and Intermediate-vision Reading Test for Greek-speaking Normal and Low Vision Adults (wDDART): Development and Validation.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Evros
      • Alexandroupolis, Evros, Greece, 68100
        • Department of Ophthalmology, University Hospital of Alexandroupolis
    • Thessaly
      • Lamía, Thessaly, Greece, 35100
        • Department of Computer Science and Biomedical Informatics, University of Thessaly

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Normal- and low-sighted participants aged 18 to 75 years

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reading Acuity (RA)
Time Frame: 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).
through study completion, an average of 3 months
Maximum Reading Speed (MRS)
Time Frame: 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.
through study completion, an average of 3 months
Critical Print Size (CPS)
Time Frame: 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.
through study completion, an average of 3 months
Accessibility Index (ACC)
Time Frame: 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.
through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraclass Correlation Coefficients (ICCs) for study participants
Time Frame: 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).
through study completion, an average of 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test-retest Intraclass Correlation Coefficients (ICCs)
Time Frame: 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).
through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Democritus University of Thrace

Collaborators

University of Thessaly

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2020

Primary Completion (Actual)

January 15, 2021

Study Completion (Actual)

February 10, 2021

Study Registration Dates

First Submitted

October 31, 2020

First Submitted That Met QC Criteria

October 31, 2020

First Posted (Actual)

November 5, 2020

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 12, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ES13/Th29/22-10-2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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