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

Completed

• Conditions: Near Vision; Presbyopia; Refractive Errors; Low Vision; Reading
• Interventions: Diagnostic Test: DDART Testing; Diagnostic Test: wDDART Testing

• Registration Number: NCT04618224
• Lead Sponsor: Democritus University of Thrace

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.

Study Timeline

• Study First Submitted: 2020-10-31
• Study First Submitted QC: 2020-10-31
• Study First Posted: 2020-11-05
• Study Start: 2020-12-02
• Primary Completion: 2021-01-15
• Status Verified: 2021-02
• Study Completion: 2021-02-10
• Last Update Submitted: 2021-02-12
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	DDART Testing	* 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.
Study group	wDDART Testing	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).

Primary Outcome Measures

Name	Time	Method
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.
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.
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).
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

Name	Time	Method
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).

Trial Locations

Locations (2)

Department of Computer Science and Biomedical Informatics, University of Thessaly; 🇬🇷 Lamía, Thessaly, Greece

Department of Ophthalmology, University Hospital of Alexandroupolis; 🇬🇷 Alexandroupolis, Evros, Greece