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

Visual Acuity Assessment in Pre-school Students.

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

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Vision Disorders; Visual Acuity; Low Vision
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 1098

Contacts and Locations

Study Locations

• Greece
  • Evros
    • Alexandroupolis, Evros, Greece, 68100
      • Democritus University of Thrace

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pre-school students aged 5-7 years old

Description

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 .

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best spectacle-corrected distance visual acuity	Visual acuity of each eye using spectacle correction	1 week

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2023
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: kindergarten; distance visual acuity; pre-school students; reading capacity
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Refractive Errors; Vision, Low; Vision Disorders
• Other Study ID Numbers: DUTH/EHDE2/20-10-2022

Drug and device information, study documents

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