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NCT Number: NCT05835193

Pre-symptomatic Screening of Visual Acuity 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

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Key information

Conditions

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

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Democritus University of Thrace

Alexandroupoli, Evros, 68100, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Diagnostic Test: Distance Visual Acuity Examination

Other

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

Primary outcomes

  1. Best spectacle-corrected distance visual acuity

    Time frame: 1 week

    Visual acuity of each eye using spectacle correction

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Official study title

Visual Acuity Assessment in Pre-school Students.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 28, 2023
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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