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

Sponsor

Democritus University of Thrace (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05835193

Collaborator

(none)

1,098

Enrollment

Location

2.3

Anticipated Duration (Months)

470.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Visual Acuity Refractive Errors Low Vision Vision Disorders	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 Design

Study Type:

Observational

Anticipated Enrollment :

1098 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Visual Acuity Assessment in Pre-school Students.

Anticipated Study Start Date :

Apr 20, 2023

Anticipated Primary Completion Date :

Jun 15, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Best spectacle-corrected distance visual acuity [1 week]
Visual acuity of each eye using spectacle correction

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 7 Years

Sexes Eligible for Study:

All

Accepts 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 .

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Democritus University of Thrace	Alexandroupolis	Evros	Greece	68100

Sponsors and Collaborators

Democritus University of Thrace

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Georgios Labiris, Professor (Associate) of Democritus University of Thrace, Democritus University of Thrace

ClinicalTrials.gov Identifier:

NCT05835193

Other Study ID Numbers:

DUTH/EHDE2/20-10-2022

First Posted:

Apr 28, 2023

Last Update Posted:

Apr 28, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Georgios Labiris, Professor (Associate) of Democritus University of Thrace, Democritus University of Thrace

kindergarten

distance visual acuity

pre-school students

reading capacity

Additional relevant MeSH terms:

Vision, Low

Vision Disorders

Refractive Errors

Study Results

No Results Posted as of Apr 28, 2023