Assessment of Visual Acuity in Refugee Population

Completed

• Conditions: Vision Disorders; Visual Acuity; Refractive Errors; Low Vision
• Interventions: Diagnostic Test: Distance Visual Acuity Examination

• Registration Number: NCT05209581
• Lead Sponsor: Democritus University of Thrace

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2022-01-13
• Study First Submitted QC: 2022-01-13
• Study Start: 2022-01-24
• Study First Posted: 2022-01-26
• Primary Completion: 2022-04-30
• Study Completion: 2022-05-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-30
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• Adult refugees or immigrants

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	Distance Visual Acuity Examination	Adult refugees/immigrants living in accommodation structures

Primary Outcome Measures

Name	Time	Method
Best spectacle-corrected distance visual acuity	1 week	Best spectacle-corrected distance visual acuity of refugees will be examined via a web-based digital visual acuity chart

Trial Locations

Locations (1)

Democritus University of Thrace; 🇬🇷 Alexandroupolis, Evros, Greece