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

Refractive Errors Clinical Trial

Official title:

Visual Acuity Assessment in Pre-school Students.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05835193
• Other study ID #: DUTH/EHDE2/20-10-2022
• Status: Completed
• Start date: April 20, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2023
• Source: Democritus University of Thrace
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1098
• Est. completion date: June 30, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 7 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Low Vision
• Refractive Errors
• Vision Disorders
• Vision, Low
• Visual Acuity

Intervention

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

Locations

Country	Name	City	State
Greece	Democritus University of Thrace	Alexandroupolis	Evros

Sponsors (1)

Lead Sponsor	Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best spectacle-corrected distance visual acuity	Visual acuity of each eye using spectacle correction	1 week