Visual AcuityNCT05835193
Pre-symptomatic Screening of Visual Acuity in Pre-school Students
An observational study of Visual Acuity and Refractive Errors, run by Democritus University of Thrace at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity, Refractive Errors, Low Vision
- What is being tested?
- Diagnostic Test: Distance Visual Acuity Examination
- How many people
- 1,098 participants
- Where
- 1 siteGreece
- Study dates
- 20 Apr 2023to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pre-school students aged 5-7 years old
Who may be able to join
- Pre-school students aged 5-7 years old.
Who cannot join
- Age >7 years old
- Students with health conditions that do not allow the evaluation of the visual acuity .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Visual Acuity Assessment 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
Read the 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.
- Conditions
- Visual Acuity, Refractive Errors, Low Vision, Vision Disorders
- Being tested
- Diagnostic Test: Distance Visual Acuity Examination
- Keywords
- kindergarten, distance visual acuity, pre-school students, reading capacity
- Medical subject headings
- Refractive Errors, Vision, Low, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 | Role | What they receive |
|---|---|---|
| Study Group | Pre-school students in Alexandroupolis, Greece Receives: Other: Diagnostic Test: Distance Visual Acuity Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best spectacle-corrected distance visual acuity
Visual acuity of each eye using spectacle correction
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start20 Apr 2023
- Primary completion15 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual AcuityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,098 participants (actual)
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Labiris, Democritus University of Thrace
- Investigators
- Georgios Labiris, MD, PhD, Study chair, Democritus University of Thrace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835193
- Sponsor's protocol ID
- DUTH/EHDE2/20-10-2022
- Status last verified
- Jun 2023
- First submitted
- 18 Apr 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Acuity Assessment in Pre-school Students.
- ClinicalTrials.gov ID
- NCT05835193
- Acronym / sponsor ID
- DUTH/EHDE2/20-10-2022
- Conditions
- Visual Acuity, Refractive Errors, Low Vision, Vision Disorders
- Keywords
- kindergarten, distance visual acuity, pre-school students, reading capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,098 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Diagnostic Test: Distance Visual Acuity ExaminationPre-school students in Alexandroupolis, Greece |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pre-school students aged 5-7 years old
Key inclusion criteria (1 listed)
- Pre-school students aged 5-7 years old.
Key exclusion criteria (2 listed)
- Age >7 years old
- Students with health conditions that do not allow the evaluation of the visual acuity .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Test: Distance Visual Acuity ExaminationBest 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 | Other | Study Group |
Primary outcome
Best spectacle-corrected distance visual acuity
Time frame: 1 week
Visual acuity of each eye using spectacle correction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgios Labiris, MD, PhD study chair
Democritus University of Thrace
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Acuity and Refractive Errors, run by Democritus University of Thrace at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best spectacle-corrected distance visual acuity (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023; AzTrials last refreshed its copy on 5 Nov 2026.