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

NCT04242836 | Completed DMC

• 1 other identifier: ES3/Th2/27-03-2019
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Presbyopia; Low Vision; Near Vision

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Intraclass Correlation Coefficients (ICCs) for study participants

  through study completion, an average of 8 months

• Test-retest Intraclass Correlation Coefficients (ICCs)

  through study completion, an average of 8 months

Study Arms (2)

Control group

1. 70 patients with normal vision (NVG) with adequate literacy of written Greek language 2. 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

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

Interventions

MNREAD testing DIAGNOSTIC_TEST

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.

Control group; Study group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• adequate literacy of written Greek language

You may not qualify if:

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

Sponsors & Collaborators

• Democritus University of Thrace: lead

Study Sites (1)

University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

Location

Related Publications (1)

• 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.

  PMID: 33102611 DERIVED

MeSH Terms

Conditions

Presbyopia; Vision, Low; Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Georgios Labiris, MD, PhD

  University Hospital of Alexandroupolis, Alexandroupolis, Greece

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 27, 2020
• Study Start: March 28, 2019
• Primary Completion: June 28, 2019
• Study Completion: November 28, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

GR (1)