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

• ClinicalTrials.gov Identifier: NCT04242836
• Recruitment Status: Completed
• First Posted: January 27, 2020
• Last Update Posted: January 27, 2020
• Sponsor: Democritus University of Thrace
• Information provided by (Responsible Party): Georgios Labiris, Democritus University of Thrace

Study Description

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.

Condition or disease	Intervention/treatment
Presbyopia; Low Vision; Near Vision	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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 15 Days
• Official Title: Development and Validation of a Computer-based Digital Near-vision Optotype Based on the Greek Version of the Print MNREAD.
• Actual Study Start Date: March 28, 2019
• Actual Primary Completion Date: June 28, 2019
• Actual Study Completion Date: November 28, 2019

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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)..

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

• adequate literacy of written Greek language

Exclusion Criteria:

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

Contacts and Locations

Locations

Greece

University Hospital of Alexandroupolis

Alexandroupolis, Evros, Greece, 68100

Sponsors and Collaborators

Democritus University of Thrace

Investigators

• Study Chair: Georgios Labiris, MD, PhD; University Hospital of Alexandroupolis, Alexandroupolis, Greece

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Georgios Labiris, Associate Professor of Ophthalmology, Democritus University of Thrace
• ClinicalTrials.gov Identifier: NCT04242836
• Other Study ID Numbers: ES3/Th2/27-03-2019
• First Posted: January 27, 2020
• Last Update Posted: January 27, 2020
• Last Verified: January 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Georgios Labiris, Democritus University of Thrace:

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

Additional relevant MeSH terms:

Vision, Low; Presbyopia; Myopia; Refractive Errors; Eye Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases