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Completed

NCT Number: NCT05209581

Assessment of Visual Acuity in Refugee Population

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).

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Democritus University of Thrace

Alexandroupoli, Evros, 68100, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Distance Visual Acuity Examination

Diagnostic Test

Best spectacle-corrected distance visual acuity of refugees/immigrants will be examined via a web-based digital visual acuity chart

Primary outcomes

  1. Best spectacle-corrected distance visual acuity

    Time frame: 1 week

    Best spectacle-corrected distance visual acuity of refugees will be examined via a web-based digital visual acuity chart

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Official study title

Assessment of Visual Acuity of the Refugee Population

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2022
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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