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Development and Validation of a Digital Optotype for Near Vision in Greek Language. (DeDART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242836
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Georgios Labiris, Democritus University of Thrace

Brief Summary:
Primary objective of our study is to develop and validate a computer-based digital near-vision optotype based on the Greek version of the print MNREAD.

Condition or disease Intervention/treatment
Presbyopia Low Vision Near Vision Diagnostic Test: MNREAD testing

Detailed Description:

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:

  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.

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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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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

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)
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.




Primary Outcome Measures :
  1. 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).


  2. 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)]

  3. 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)]

  4. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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)..



Information from the National Library of Medicine

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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
Study Population
Normal- and low-sighted participants aged 18 to 75 years
Criteria

Inclusion Criteria:

  • adequate literacy of written Greek language

Exclusion Criteria:

  • dyslexia
  • attention-deficiency
  • former diagnosis of mental diseases
  • former diagnosis of psychiatric diseases

Information from the National Library of Medicine

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


Locations
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Greece
University Hospital of Alexandroupolis
Alexandroupolis, Evros, Greece, 68100
Sponsors and Collaborators
Democritus University of Thrace
Investigators
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Study Chair: Georgios Labiris, MD, PhD University Hospital of Alexandroupolis, Alexandroupolis, Greece
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Georgios Labiris, Democritus University of Thrace:
digital near vision chart
critical print size
reading acuity
reading speed
digital Greek MNREAD
Additional relevant MeSH terms:
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Vision, Low
Presbyopia
Myopia
Refractive Errors
Eye Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms