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Completed

NCT Number: NCT04242836

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

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.

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Key information

Conditions

Presbyopia Eye Diseases Low Vision Myopia Near Vision Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Refractive Errors Sensation Disorders Signs and Symptoms Vision Disorders Vision, Low

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adequate literacy of written Greek language

Exclusion criteria

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

Treatment and study plan

MNREAD testing

Diagnostic Test

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 outcomes

  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 outcomes

  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)..

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Official study title

Development and Validation of a Computer-based Digital Near-vision Optotype Based on the Greek Version of the Print MNREAD.

Acronym: DeDART

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 27, 2020
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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