Pre-symptomatic Screening of Visual Acuity in Pre-school Students

Democritus University of Thrace (Other)
Overall Status
Not yet recruiting ID

Study Details

Study Description

Brief Summary

The present research process is a prospective, non-interventional clinical study that will be conducted -under the auspices of the Democritus University of Thrace (DUTH)- in the pre-school students of the city of Alexandroupolis, Greece.

  • The study aims to assess the visual acuity of the kindergarten students.

  • The measurement of monocular best-spectacle corrected visual acuity will be performed using a web-based visual acuity chart

Condition or Disease Intervention/Treatment Phase
  • Other: Diagnostic Test: Distance Visual Acuity Examination

Detailed Description

Study protocol will adhere to the tenets of the Declaration of Helsinki and written informed consent will be obtained by the legal guardians of all participants.

The measurement of the visual acuity (monocular and binocular) will be performed using DDART, a digital visual acuity tool that has been developed and validated by the Democritus University of Thrace and is also an approved Category 1 Medical Device by the country's National Organization for Medicines, via a web-based digital chart in a high-resolution screen. The same environmental lighting conditions and the same screen brightness will be applied. The examination will be performed at the same predetermined viewing distance.

Finally, according to each participant's visual acuity, appropriate instructions will be given for further examinations directly to the legal guardians in order to comply with the GDPR.

Study Design

Study Type:
Anticipated Enrollment :
1098 participants
Observational Model:
Time Perspective:
Official Title:
Visual Acuity Assessment in Pre-school Students.
Anticipated Study Start Date :
Apr 20, 2023
Anticipated Primary Completion Date :
Jun 15, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Study Group

Pre-school students in Alexandroupolis, Greece

Other: Diagnostic Test: Distance Visual Acuity Examination
Best spectacle-corrected distance visual acuity and reading capacity of pre-school students in Alexandroupolis, Greece will be examined via a web-based digital visual acuity chart

Outcome Measures

Primary Outcome Measures

  1. Best spectacle-corrected distance visual acuity [1 week]

    Visual acuity of each eye using spectacle correction

Eligibility Criteria


Ages Eligible for Study:
5 Years to 7 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • Pre-school students aged 5-7 years old.
Exclusion Criteria:
  • Age >7 years old

  • Students with health conditions that do not allow the evaluation of the visual acuity .

Contacts and Locations


Site City State Country Postal Code
1 Democritus University of Thrace Alexandroupolis Evros Greece 68100

Sponsors and Collaborators

  • Democritus University of Thrace


  • Study Chair: Georgios Labiris, MD, PhD, Democritus University of Thrace

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Georgios Labiris, Professor (Associate) of Democritus University of Thrace, Democritus University of Thrace Identifier:
Other Study ID Numbers:
  • DUTH/EHDE2/20-10-2022
First Posted:
Apr 28, 2023
Last Update Posted:
Apr 28, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Georgios Labiris, Professor (Associate) of Democritus University of Thrace, Democritus University of Thrace
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2023