Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05835193
Other study ID # DUTH/EHDE2/20-10-2022
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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 .

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT04532099 - Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses N/A
Completed NCT05039112 - Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses N/A
Completed NCT03670303 - Trial of an Educational Intervention to Promote Spectacle Use Among Secondary School Children in Islamabad, Pakistan N/A
Completed NCT02255474 - Bifocal Lenses In Nearsighted Kids N/A
Not yet recruiting NCT03222661 - Direct Comparison of SVOne Obtained Refraction to Subjective Manifest Refraction N/A
Completed NCT04055519 - Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens N/A
Recruiting NCT05049070 - Study to Evaluate the Reliability, Validity and Safety of Subjective Mobile Refraction N/A
Completed NCT04527978 - Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1 N/A
Completed NCT01430247 - Vision Screening for the Detection of Amblyopia N/A
Recruiting NCT06077682 - Cycloplegic Refraction in Pediatric Patients With Esotropia Phase 4
Not yet recruiting NCT04077086 - Correcting Myopia Among Secondary School Children to Increase Academic High School Attendance Rates in Rural Communities N/A
Withdrawn NCT04352868 - Customizing Myopia Control With Multifocal Toric Contact Lens N/A
Completed NCT04528017 - Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 2 N/A
Recruiting NCT04338880 - Academic Performance and Refractive Error
Recruiting NCT04545073 - Outcomes of a Trifocal IOL in Post-refractive Patients
Enrolling by invitation NCT05992675 - Air Optix® Night and Day® Aqua Continuous Wear
Enrolling by invitation NCT05976750 - Air Optix® Night and Day® Aqua Daily Wear
Recruiting NCT04693247 - Handheld Device Compared With a Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction N/A
Recruiting NCT06065631 - Seeing to Learn in Sierra Leone N/A
Not yet recruiting NCT05550740 - Repeated Low-Level Red-Light Therapy for Shortening Axial Length N/A