Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04242836
Acronym
DeDART
Enrollment
100
Registered
2020-01-27
Start date
2019-03-28
Completion date
2019-11-28
Last updated
2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Vision, Near Vision, Presbyopia

Keywords

digital near vision chart, critical print size, reading acuity, reading speed, digital Greek MNREAD

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.

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.

Interventions

DIAGNOSTIC_TESTMNREAD 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.

Sponsors

Democritus University of Thrace
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* adequate literacy of written Greek language

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Reading Acuity (RA)through study completion, an average of 8 monthsThe 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)through study completion, an average of 8 monthsThe 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)through study completion, an average of 8 monthsThe 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)through study completion, an average of 8 monthsThe 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

MeasureTime frameDescription
Intraclass Correlation Coefficients (ICCs) for study participantsthrough study completion, an average of 8 monthsLevel 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)through study completion, an average of 8 monthsTest-retest reliability of the digital optotype is evaluated by ICCs for the 4 reading parameters (RA, MRS, CPS, ACC)..

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026