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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Pre-school students in Alexandroupolis, Greece |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Test: Distance Visual Acuity Examination | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Best spectacle-corrected distance visual acuity | Visual acuity of each eye using spectacle correction | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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Pre-school students aged 5-7 years old
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| Name | Affiliation | Role |
|---|---|---|
| Georgios Labiris, MD, PhD | Democritus University of Thrace | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Democritus University of Thrace | Alexandroupoli | Evros | 68100 | Greece |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D015354 | Vision, Low |
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |