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Assessment of Visual Acuity in Refugee Population

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ClinicalTrials.gov Identifier: NCT05209581
Recruitment Status : Not yet recruiting
First Posted : January 26, 2022
Last Update Posted : January 26, 2022
Sponsor:
Information provided by (Responsible Party):
Georgios Labiris, 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).


Condition or disease Intervention/treatment
Visual Acuity Refractive Errors Low Vision Vision Disorders Diagnostic Test: Distance Visual Acuity Examination

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: Assessment of Visual Acuity of the Refugee Population
Estimated Study Start Date : January 24, 2022
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort Intervention/treatment
Study Group
Adult refugees/immigrants living in accommodation structures
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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Normal- and low-vision adult refugees or immigrants living in accommodation structures
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05209581


Contacts
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Contact: Georgios Labiris, MD, PhD 00302551030405 labiris@usa.net
Contact: Eirini - Kanella Panagiotopoulou, MD 00306978730858 eipanagi@med.duth.gr

Locations
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Greece
Democritus University of Thrace
Alexandroupolis, Evros, Greece, 68100
Contact: Georgios Labiris, MD, PhD    00302551030990    labiris@usa.net   
Sponsors and Collaborators
Democritus University of Thrace
Investigators
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Study Chair: Georgios Labiris, MD, PhD Democritus University of Thrace
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Responsible Party: Georgios Labiris, Professor (Associate) of Democritus University of Thrace, Democritus University of Thrace
ClinicalTrials.gov Identifier: NCT05209581    
Other Study ID Numbers: DUTh REC/4/16-12-2021
First Posted: January 26, 2022    Key Record Dates
Last Update Posted: January 26, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Georgios Labiris, Democritus University of Thrace:
distance visual acuity
refugee
immigrant
Additional relevant MeSH terms:
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Vision, Low
Vision Disorders
Refractive Errors
Eye Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases