Assessment of Visual Acuity in Refugee Population

Sponsor

Democritus University of Thrace (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05209581

Collaborator

(none)

300

Enrollment

Location

11.2

Anticipated Duration (Months)

26.8

Patients Per Site Per Month

Study Details

Study Description

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:

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.)
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	Phase
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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Assessment of Visual Acuity of the Refugee Population

Anticipated Study Start Date :

Jan 24, 2022

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Democritus University of Thrace	Alexandroupolis	Evros	Greece	68100

Sponsors and Collaborators

Democritus University of Thrace

Investigators

Study Chair: Georgios Labiris, MD, PhD, Democritus University of Thrace

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Jan 26, 2022

Last Update Posted:

Jan 26, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Georgios Labiris, Professor (Associate) of Democritus University of Thrace, Democritus University of Thrace

distance visual acuity

refugee

immigrant

Additional relevant MeSH terms:

Vision, Low

Vision Disorders

Refractive Errors

Study Results

No Results Posted as of Jan 26, 2022