Clinical trial NCT04618224: Development and Validation of an Internet-based Near and Intermediate-vision Reading Test
Official title: Introduction of an Internet-based Near and Intermediate-vision Reading Test for Greek-speaking Normal and Low Vision Adults (wDDART): Development and Validation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Presbyopia
Refractive Errors
Low Vision
Near Vision
Reading
Keywords: internet-based digital reading test
smart features
face detection
reading acuity
reading speed
critical print size
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
Collaborators: name: University of Thessaly
First posted: 2020-11-05
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 an internet-based digital near and intermediate-vision reading test in the greek language.

Detailed description: Present study aims to develop and validate a computer-based digital near-vision reading test (web Democritus Digital Acuity Reading Test - wDDART) based on the validated digital DDART.

Specifically, present study aims to develop a new online reading test (wDDART) based on the corresponding digital DDART reading test for Windows and to evaluate the level of agreement between the two reading tests, as well as test-retest reliability of the online wDDART reading test.

The first part of the study is the development of the online reading test, which will include the following new smart features:

1. Automatic calculation of the reading time of each sentence (each logMAR)
2. Automatic calculation of the basic reading parameters - RA, MRS, CPS, ACC - immediately after the completion of the examination
3. Adjustment of the font size according to the size of the computer screen used for the examination
4. Real time calculation of the patient-screen distance through a face detection system

The second part of this study is the clinical validation of the online wDDART reading test. In this part, four reading parameters measured with the digital and the online 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
* Age between 18 to 75 years

Exclusion Criteria:

* Dyslexia
* Attention-deficiency
* Former diagnosis of mental and/or psychiatric diseases

Primary outcomes:
measure: Reading Acuity (RA)
timeFrame: through study completion, an average of 3 months
measure: Maximum Reading Speed (MRS)
timeFrame: through study completion, an average of 3 months
measure: Critical Print Size (CPS)
timeFrame: through study completion, an average of 3 months
measure: Accessibility Index (ACC)
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: Intraclass Correlation Coefficients (ICCs) for study participants
timeFrame: through study completion, an average of 3 months
Other outcomes:
measure: Test-retest Intraclass Correlation Coefficients (ICCs)
timeFrame: through study completion, an average of 3 months
Locations:
city: Alexandroupolis
country: Greece
facility: Department of Ophthalmology, University Hospital of Alexandroupolis
state: Evros
city: Lamía
country: Greece
facility: Department of Computer Science and Biomedical Informatics, University of Thessaly
state: Thessaly
Study officials:
affiliation: Department of Ophthalmology, 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.
citation: Labiris G, Panagiotopoulou EK, Duzha E, Tzinava M, Perente A, Konstantinidis A, Delibasis K. Development and Validation of a Web-Based Reading Test for Normal and Low Vision Patients. Clin Ophthalmol. 2021 Sep 22;15:3915-3929. doi: 10.2147/OPTH.S314943. eCollection 2021.