Development and Validation of an Internet-based Near and Intermediate-vision Reading Test
NCT ID: NCT04618224
Last Updated: 2021-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2020-12-02
2021-02-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Control group
* 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.
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.
Study group
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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age between 18 to 75 years
Exclusion Criteria
* Attention-deficiency
* Former diagnosis of mental and/or psychiatric diseases
18 Years
75 Years
ALL
Yes
Sponsors
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University of Thessaly
OTHER
Democritus University of Thrace
OTHER
Responsible Party
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Georgios Labiris
Professor (Associate) of Democritus University of Thrace
Principal Investigators
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Georgios Labiris, MD, PhD
Role: STUDY_CHAIR
Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
Locations
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Department of Ophthalmology, University Hospital of Alexandroupolis
Alexandroupoli, Evros, Greece
Department of Computer Science and Biomedical Informatics, University of Thessaly
LamÃa, Thessaly, Greece
Countries
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References
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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/s40662-020-00216-0. eCollection 2020.
Labiris G, Panagiotopoulou EK, Duzha E, Tzinava M, Perente A, Konstantinidis A, Delibasis K. Development and Validation of a Web-Based Reading Test for Normal and Low Vision Patients. Clin Ophthalmol. 2021 Sep 22;15:3915-3929. doi: 10.2147/OPTH.S314943. eCollection 2021.
Other Identifiers
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ES13/Th29/22-10-2020
Identifier Type: -
Identifier Source: org_study_id
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