Development and Validation of a Digital Optotype for Near Vision in Greek Language. (DeDART)
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ClinicalTrials.gov Identifier: NCT04242836 |
Recruitment Status :
Completed
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
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Condition or disease | Intervention/treatment |
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Presbyopia Low Vision Near Vision | Diagnostic Test: MNREAD testing |
Present study aims to develop and validate a computer-based digital near-vision optotype based on the Greek version of the print MNREAD.
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:
- 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 : | Observational [Patient Registry] |
Actual Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 15 Days |
Official Title: | Development and Validation of a Computer-based Digital Near-vision Optotype Based on the Greek Version of the Print MNREAD. |
Actual Study Start Date : | March 28, 2019 |
Actual Primary Completion Date : | June 28, 2019 |
Actual Study Completion Date : | November 28, 2019 |

Group/Cohort | Intervention/treatment |
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Control group
These patients are tested on the printed Greek MNREAD |
Diagnostic Test: 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)
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Diagnostic Test: 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. |
- Reading Acuity (RA) [ Time Frame: through study completion, an average of 8 months ]
The smallest print that the patient can read without making significant errors, and can be calculated by the following formula:
Acuity (in logMAR)= 1.4 - (sentences x 0.1) + (errors x 0.01).
- Maximum Reading Speed (MRS) [ Time Frame: through study completion, an average of 8 months ]The patient's reading speed when reading is not limited by print size , and is calculated by averaging the speed of the sentences with print size larger than the CPS. [(in words per minute (wpm)]
- Critical Print Size (CPS) [ Time Frame: through study completion, an average of 8 months ]The smallest print size at which patients can read with their MRS, and is identified as the print size of the sentence fulfilling this criterion: all of the following sentences are read at a speed that is 1.96 times the standard deviation below the average of the larger preceding sentences (that is the MRS). In other words, it is defined as the smallest print size that yields 90% of the MRS [(in logMAR)]
- Accessibility Index (ACC) [ Time Frame: through study completion, an average of 8 months ]The mean reading speed measured across the 10 largest print sizes (1.3 to 0.4 logMAR) of the MNREAD Acuity Chart at 40 cm normalized by 200 wpm, which was the mean value for a group of 365 normally sighted young adults aged 18 to 39 years old.
- Intraclass Correlation Coefficients (ICCs) for study participants [ Time Frame: through study completion, an average of 8 months ]Level of agreement between the print and the digital version are evaluated by calculation of the ICCs for the 4 reading parameters (RA, MRS, CPS, ACC).
- Test-retest Intraclass Correlation Coefficients (ICCs) [ Time Frame: through study completion, an average of 8 months ]Test-retest reliability of the digital optotype is evaluated by ICCs for the 4 reading parameters (RA, MRS, CPS, ACC)..

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- adequate literacy of written Greek language
Exclusion Criteria:
- dyslexia
- attention-deficiency
- former diagnosis of mental diseases
- former diagnosis of psychiatric diseases

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242836
Greece | |
University Hospital of Alexandroupolis | |
Alexandroupolis, Evros, Greece, 68100 |
Study Chair: | Georgios Labiris, MD, PhD | University Hospital of Alexandroupolis, Alexandroupolis, Greece |
Responsible Party: | Georgios Labiris, Associate Professor of Ophthalmology, Democritus University of Thrace |
ClinicalTrials.gov Identifier: | NCT04242836 |
Other Study ID Numbers: |
ES3/Th2/27-03-2019 |
First Posted: | January 27, 2020 Key Record Dates |
Last Update Posted: | January 27, 2020 |
Last Verified: | January 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
digital near vision chart critical print size reading acuity reading speed digital Greek MNREAD |
Vision, Low Presbyopia Myopia Refractive Errors Eye Diseases |
Vision Disorders Sensation Disorders Neurologic Manifestations Nervous System Diseases |