Clinical trial NCT05209581: Assessment of Visual Acuity in Refugee Population
Official title: Assessment of Visual Acuity of the Refugee Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Acuity
Refractive Errors
Low Vision
Vision Disorders
Keywords: distance visual acuity
refugee
immigrant
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Normal- and low-vision adult refugees or immigrants living in accommodation structures

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.

Eligibility criteria: 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

Primary outcomes:
measure: Best spectacle-corrected distance visual acuity
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: Democritus University of Thrace
state: Evros
Study officials:
affiliation: Democritus University of Thrace
name: Georgios Labiris, MD, PhD
role: STUDY_CHAIR
References: