Assessment of Visual Acuity in Refugee Population

Refractive Errors Clinical Trial

Official title:

Assessment of Visual Acuity of the Refugee Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05209581
• Other study ID #: DUTh REC/4/16-12-2021
• Status: Completed
• Start date: January 24, 2022
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2023
• Source: Democritus University of Thrace
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The present research process is a prospective clinical study that will be conducted under the auspices of the Democritus University of Thrace (DUTH) in the open accommodation structure for refugees and immigrants of Kavala, Kavala, Greece, and the Pre-Removal Detention Center (PROKEKA) for Foreigners of Kos, Kos, Greece. The study aims to assess the basic ophthalmological condition of the refugee/immigrant population and is developed in two main areas: 1. The recording of the ophthalmological care that the refugee/immigrant has received until his/her inclusion in the study through a structured questionnaire (eg previous examinations, spectacle utilization, pharmaceutical or other interventions, etc.) 2. The measurement of monocular best-spectacle corrected visual acuity in both eyes using a web-based visual acuity chart. Adult participants living in the two aforementioned centers will be recruited in a consecutive-if-eligible basis. All age groups will be proportionally represented (proportional age distribution).

Description:

Study protocol will adheres to the tenets of the Helsinki Declaration and written informed consent translated in the language of each examinee will be obtained by all participants. Subsequently, participants will complete a questionnaire about demographic and general clinical information. Then, the best spectacle-corrected distance visual acuity of each participant's both eyes will be evaluated monocularly 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 the improvement of his/her eye care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: May 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Adult refugees or immigrants

Exclusion Criteria:

• Visual acuity lower than 1.0 LogMAR
• Age <18 years
• Refugees or immigrants living in the accommodation structures without yet having the appropriate legal documents

Related Conditions & MeSH terms

• Low Vision
• Refractive Errors
• Vision Disorders
• Vision, Low
• Visual Acuity

Intervention

Diagnostic Test:
• Distance Visual Acuity Examination
Best spectacle-corrected distance visual acuity of refugees/immigrants 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	Best spectacle-corrected distance visual acuity of refugees will be examined via a web-based digital visual acuity chart	1 week