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

Visual Acuity Assessment in Pre-school Students.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05835193
Enrollment
1098
Registered
2023-04-28
Start date
2023-04-20
Completion date
2023-06-30
Last updated
2023-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Vision, Refractive Errors, Vision Disorders, Visual Acuity

Keywords

kindergarten, distance visual acuity, pre-school students, reading capacity

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.

Interventions

OTHERDiagnostic 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

Sponsors

Democritus University of Thrace
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 7 Years
Healthy volunteers
Yes

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 .

Design outcomes

Primary

MeasureTime frameDescription
Best spectacle-corrected distance visual acuity1 weekVisual acuity of each eye using spectacle correction

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026