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

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

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia; Low Vision; Near Vision
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Greece
  • Evros
    • Alexandroupolis, Evros, Greece, 68100
      • University Hospital of Alexandroupolis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Normal- and low-sighted participants aged 18 to 75 years

Description

Inclusion Criteria:

• adequate literacy of written Greek language

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; 70 patients with normal vision (NVG) with adequate literacy of written Greek language; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reading Acuity (RA)	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).	through study completion, an average of 8 months
Maximum Reading Speed (MRS)	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)]	through study completion, an average of 8 months
Critical Print Size (CPS)	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)]	through study completion, an average of 8 months
Accessibility Index (ACC)	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.	through study completion, an average of 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraclass Correlation Coefficients (ICCs) for study participants	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).	through study completion, an average of 8 months
Test-retest Intraclass Correlation Coefficients (ICCs)	Test-retest reliability of the digital optotype is evaluated by ICCs for the 4 reading parameters (RA, MRS, CPS, ACC)..	through study completion, an average of 8 months

Collaborators and Investigators

• Sponsor: Democritus University of Thrace
• Investigators: Study Chair: Georgios Labiris, MD, PhD, University Hospital of Alexandroupolis, Alexandroupolis, Greece

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2019
• Primary Completion (Actual): June 28, 2019
• Study Completion (Actual): November 28, 2019

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: January 24, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: digital near vision chart; critical print size; reading acuity; reading speed; digital Greek MNREAD
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Refractive Errors; Vision Disorders; Presbyopia; Myopia; Vision, Low
• Other Study ID Numbers: ES3/Th2/27-03-2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No