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

Presbyopia Clinical Trial

— wDDART  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04618224
• Other study ID #: ES13/Th29/22-10-2020
• Status: Completed
• Start date: December 2, 2020
• Est. completion date: February 10, 2021

Study information

• Verified date: February 2021
• Source: Democritus University of Thrace
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 10, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Low Vision
• Near Vision
• Presbyopia
• Reading
• Refractive Errors
• Vision, Low

Intervention

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.
• 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.

Locations

Country	Name	City	State
Greece	Department of Ophthalmology, University Hospital of Alexandroupolis	Alexandroupolis	Evros
Greece	Department of Computer Science and Biomedical Informatics, University of Thessaly	Lamía	Thessaly

Sponsors (2)

Lead Sponsor	Collaborator
Democritus University of Thrace	University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (1)

Labiris G, Panagiotopoulou EK, Chatzimichael E, Tzinava M, Mataftsi A, Delibasis K. Introduction of a digital near-vision reading test for normal and low vision adults: development and validation. Eye Vis (Lond). 2020 Oct 22;7:51. doi: 10.1186/s40662-020- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Test-retest Intraclass Correlation Coefficients (ICCs)	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
Primary	Reading Acuity (RA)	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
Primary	Maximum Reading Speed (MRS)	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
Primary	Critical Print Size (CPS)	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
Primary	Accessibility Index (ACC)	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	Intraclass Correlation Coefficients (ICCs) for study participants	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