- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04618224
Development and Validation of an Internet-based Near and Intermediate-vision Reading Test (wDDART)
Introduction of an Internet-based Near and Intermediate-vision Reading Test for Greek-speaking Normal and Low Vision Adults (wDDART): Development and Validation.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Evros
-
Alexandroupolis, Evros, Greece, 68100
- Department of Ophthalmology, University Hospital of Alexandroupolis
-
-
Thessaly
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Lamía, Thessaly, Greece, 35100
- Department of Computer Science and Biomedical Informatics, University of Thessaly
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control group
These patients are tested on the digital reading test DDART. |
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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reading Acuity (RA)
Time Frame: 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). |
through study completion, an average of 3 months
|
Maximum Reading Speed (MRS)
Time Frame: 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.
|
through study completion, an average of 3 months
|
Critical Print Size (CPS)
Time Frame: 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.
|
through study completion, an average of 3 months
|
Accessibility Index (ACC)
Time Frame: 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.
|
through study completion, an average of 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraclass Correlation Coefficients (ICCs) for study participants
Time Frame: 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).
|
through study completion, an average of 3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Test-retest Intraclass Correlation Coefficients (ICCs)
Time Frame: through study completion, an average of 3 months
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ES13/Th29/22-10-2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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