An observational study in Presbyopia, Refractive Errors and Low Vision, sponsored by Democritus University of Thrace. Completed at 2 sites in Greece. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-16.
Sponsored by Democritus University of Thrace · Observational
Primary objective of our study is to develop and validate an internet-based digital near and intermediate-vision reading test in the greek language.
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:
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:
214 studies on the registry are indexed under Vision, Low; 41 are open to participants now.
This study's enrollment of 100 is below the median of 141 across 51 observational studies indexed under Vision, Low.
Browse Vision, Low studies →Democritus University of Thrace is the lead sponsor of 70 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Normal- and low-sighted participants aged 18 to 75 years
Exclusion Criteria:
* 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
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 DDART near vision test with defined environmental conditions at 40 cm viewing distance. All four parameters (RA, MRS, CPS and ACC) are evaluated.
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.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: through study completion, an average of 3 months
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).
Time frame: through study completion, an average of 3 months
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).
Time frame: through study completion, an average of 3 months
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Democritus University of Thrace