Development and Validation of an Internet-based Near and Intermediate-vision Reading Test

NCT04618224 | Completed DMC

• 1 other identifier: ES13/Th29/22-10-2020
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (4)

• Reading Acuity (RA)

  The smallest print that can be read by the patient easily (measured in logMAR). It is calculated by the following formula: RA = 1.4 - (sentences x 0.1) + (errors x 0.01).

  through study completion, an average of 3 months

• Maximum Reading Speed (MRS)

  The patient's reading speed (measured in wpm) when reading is not limited by print size. It is calculated by averaging the reading speed of the sentences with print size larger than the CPS.

  through study completion, an average of 3 months

• Critical Print Size (CPS)

  The smallest print size (measured in logMAR) that can be read with the MRS, i.e., with speed greater than or equal to the average reading speed of the larger logMAR print sentences minus 1.96 times the standard deviation (SD) of the reading speed of these sentences.

  through study completion, an average of 3 months

• Accessibility Index (ACC)

  The mean reading speed of the 10 largest print sizes at 40 cm (1.3 to 0.4 logMAR), divided by 200 wpm, which is the mean reading speed of normally sighted young adults aged 18 to 39 years old. This parameter was designed for better evaluation of one's access to text across the range of the 10 most common print sizes found in everyday life. For instance, a value of 0 means no access to commonly encountered printed material, while 1.0 is the mean value for normally sighted young adults that indicates reading fluency within the everyday life print sizes.

  through study completion, an average of 3 months

Secondary Outcomes (1)

• Intraclass Correlation Coefficients (ICCs) for study participants

  through study completion, an average of 3 months

Other Outcomes (1)

• Test-retest Intraclass Correlation Coefficients (ICCs)

  through study completion, an average of 3 months

Study Arms (2)

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 digital reading test DDART.

Diagnostic Test: DDART Testing

Study group

The same patients as those in the control group (NVG, LVG) are tested on the online version of the Greek digital reading test DDART (wDDART).

Diagnostic Test: wDDART Testing

Interventions

DDART Testing DIAGNOSTIC_TEST

One randomly selected eye is included for each study participant. Participants respond to the DDART near vision test with defined environmental conditions at 40 cm viewing distance. All four parameters (RA, MRS, CPS and ACC) are evaluated.

Control group

wDDART Testing DIAGNOSTIC_TEST

One randomly selected eye is included for each study participant. Participants respond to the wDDART near vision test with defined environmental conditions at 40 cm viewing distance. All four parameters (RA, MRS, CPS and ACC) are evaluated.

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
• Age between 18 to 75 years

You may not qualify if:

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

Sponsors & Collaborators

• Democritus University of Thrace: lead
• University of Thessaly: collaborator

Study Sites (2)

Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

Location

Department of Computer Science and Biomedical Informatics, University of Thessaly

Lamía, Thessaly, 35100, Greece

Location

Related Publications (2)

• 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 RESULT

• 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.

  PMID: 34588763 DERIVED

MeSH Terms

Conditions

Presbyopia; Refractive Errors; Vision, Low; Myopia

Condition Hierarchy (Ancestors)

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

  Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Associate) of Democritus University of Thrace

Study Record Dates

• First Submitted: October 31, 2020
• First Posted: November 5, 2020
• Study Start: December 2, 2020
• Primary Completion: January 15, 2021
• Study Completion: February 10, 2021
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

GR (2)