Development and Validation of a Digital Optotype for Near Vision in Greek Language.
NCT ID: NCT04242836
Last Updated: 2020-01-27
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
2019-03-28
2019-11-28
Brief Summary
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Detailed Description
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Specifically, it aims to evaluate the level of agreement between the conventional printed greek MNREAD chart and the corresponding digital chart, as well as test-retest reliability of the digital optotype.
To address these aims, four reading parameters measured with the print and the digital 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
1. 70 patients with normal vision (NVG) with adequate literacy of written Greek language
2. 30 patients with low vision (LVG) with adequate literacy of written Greek language
These patients are tested on the printed Greek MNREAD
MNREAD testing
One randomly selected eye is included for each study participant. Participants respond to the near vision chart with defined environmental circumstances at 40cm 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 digital version of the Greek MNREAD (DeDART)
MNREAD testing
One randomly selected eye is included for each study participant. Participants respond to the near vision chart with defined environmental circumstances at 40cm viewing distance. All four parameters (RA, MRS, CPS and ACC) are evaluated.
Interventions
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MNREAD testing
One randomly selected eye is included for each study participant. Participants respond to the near vision chart with defined environmental circumstances at 40cm viewing distance. All four parameters (RA, MRS, CPS and ACC) are evaluated.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* attention-deficiency
* former diagnosis of mental diseases
* former diagnosis of psychiatric diseases
18 Years
75 Years
ALL
Yes
Sponsors
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Democritus University of Thrace
OTHER
Responsible Party
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Georgios Labiris
Associate Professor of Ophthalmology
Principal Investigators
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Georgios Labiris, MD, PhD
Role: STUDY_CHAIR
University Hospital of Alexandroupolis, Alexandroupolis, Greece
Locations
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University Hospital of Alexandroupolis
Alexandroupoli, Evros, 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.
Other Identifiers
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ES3/Th2/27-03-2019
Identifier Type: -
Identifier Source: org_study_id
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