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

Study Overview
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Brief Summary
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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
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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: Automatic calculation of the reading time of each sentence (each logMAR) Automatic calculation of the basic reading parameters - RA, MRS, CPS, ACC - immediately after the completion of the examination Adjustment of the font size according to the size of the computer screen used for the examination 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: Reading Acuity (RA) Maximum Reading Speed (MRS) Critical Print Size (CPS) 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.

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

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

Intervention / Treatment
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* Diagnostic Test: DDART Testing
* Diagnostic Test: wDDART Testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>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<br>* 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.<br>|
| Study group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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internet-based digital reading test, smart features, face detection, reading acuity, reading speed, critical print size