NCT05835193

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,098

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

April 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

July 5, 2023

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

April 18, 2023

Last Update Submit

June 30, 2023

Conditions

Visual AcuityRefractive ErrorsLow VisionVision Disorders

Keywords

kindergartendistance visual acuitypre-school studentsreading capacity

Outcome Measures

Primary Outcomes (1)

  • Best spectacle-corrected distance visual acuity

    Visual acuity of each eye using spectacle correction

    1 week

Study Arms (1)

Study Group

Pre-school students in Alexandroupolis, Greece

Other: Diagnostic Test: Distance Visual Acuity Examination

Interventions

Diagnostic Test: Distance Visual Acuity ExaminationOTHER

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

Study Group

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pre-school students aged 5-7 years old

You may qualify if:

  • Pre-school students aged 5-7 years old.

You may not qualify if:

  • Age \>7 years old
  • Students with health conditions that do not allow the evaluation of the visual acuity .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Democritus University of Thrace

Alexandroupoli, Evros, 68100, Greece

Location

MeSH Terms

Conditions

Refractive ErrorsVision, LowVision Disorders

Condition Hierarchy (Ancestors)

Eye DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Georgios Labiris, MD, PhD

    Democritus University of Thrace

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor (Associate) of Democritus University of Thrace

Study Record Dates

First Submitted

April 18, 2023

First Posted

April 28, 2023

Study Start

April 20, 2023

Primary Completion

June 15, 2023

Study Completion

June 30, 2023

Last Updated

July 5, 2023

Record last verified: 2023-06

Locations

GR(1)