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

Completed

• Conditions: Refractive Errors; Visual Acuity; Low Vision; Vision Disorders

• Registration Number: NCT05835193
• Lead Sponsor: Democritus University of Thrace

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

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 Timeline

• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-04-18
• Study Start: 2023-04-20
• Study First Posted: 2023-04-28
• Status Verified: 2023-06
• Primary Completion: 2023-06-15
• Study Completion: 2023-06-30
• Last Update Submitted: 2023-06-30
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1098

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best spectacle-corrected distance visual acuity	1 week	Visual acuity of each eye using spectacle correction

Trial Locations

Locations (1)

Democritus University of Thrace; 🇬🇷 Alexandroupolis, Evros, Greece