Skip to main content
Clinical Trials/NCT04618224
NCT04618224
Completed
Not Applicable

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

Democritus University of Thrace2 sites in 1 country100 target enrollmentDecember 2, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Presbyopia
Sponsor
Democritus University of Thrace
Enrollment
100
Locations
2
Primary Endpoint
Maximum Reading Speed (MRS)
Status
Completed
Last Updated
5 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 2, 2020
End Date
February 10, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Georgios Labiris

Professor (Associate) of Democritus University of Thrace

Democritus University of Thrace

Eligibility Criteria

Inclusion Criteria

  • Adequate literacy of written Greek language
  • Age between 18 to 75 years

Exclusion Criteria

  • Attention-deficiency
  • Former diagnosis of mental and/or psychiatric diseases

Outcomes

Primary Outcomes

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.

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.

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).

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.

Secondary Outcomes

  • Intraclass Correlation Coefficients (ICCs) for study participants(through study completion, an average of 3 months)

Study Sites (2)

Loading locations...

Similar Trials