Clinical trial NCT04242836: Development and Validation of a Digital Optotype for Near Vision in Greek Language.
Official title: Development and Validation of a Computer-based Digital Near-vision Optotype Based on the Greek Version of the Print MNREAD.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Presbyopia
Low Vision
Near Vision
Keywords: digital near vision chart
critical print size
reading acuity
reading speed
digital Greek MNREAD
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Normal- and low-sighted participants aged 18 to 75 years

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.

Eligibility criteria: Inclusion Criteria:

* adequate literacy of written Greek language

Exclusion Criteria:

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

Primary outcomes:
measure: Reading Acuity (RA)
timeFrame: through study completion, an average of 8 months
measure: Maximum Reading Speed (MRS)
timeFrame: through study completion, an average of 8 months
measure: Critical Print Size (CPS)
timeFrame: through study completion, an average of 8 months
measure: Accessibility Index (ACC)
timeFrame: through study completion, an average of 8 months
Secondary outcomes:
measure: Intraclass Correlation Coefficients (ICCs) for study participants
timeFrame: through study completion, an average of 8 months
measure: Test-retest Intraclass Correlation Coefficients (ICCs)
timeFrame: through study completion, an average of 8 months
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: University Hospital of Alexandroupolis
state: Evros
Study officials:
affiliation: University Hospital of Alexandroupolis, Alexandroupolis, Greece
name: Georgios Labiris, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.