NCT05209581

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. 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. 2.The measurement of monocular best-spectacle corrected visual acuity in both eyes using a web-based visual acuity chart.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

January 24, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

July 5, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

January 13, 2022

Last Update Submit

June 30, 2023

Conditions

Keywords

distance visual acuityrefugeeimmigrant

Outcome Measures

Primary Outcomes (1)

  • Best spectacle-corrected distance visual acuity

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

    1 week

Study Arms (1)

Study Group

Adult refugees/immigrants living in accommodation structures

Diagnostic Test: Distance Visual Acuity Examination

Interventions

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

Study Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Normal- and low-vision adult refugees or immigrants living in accommodation structures

You may qualify if:

  • Adult refugees or immigrants

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Democritus University of Thrace

Alexandroupoli, Evros, 68100, Greece

Location

MeSH Terms

Conditions

Refractive ErrorsVision, LowVision Disorders

Condition Hierarchy (Ancestors)

Eye DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Georgios Labiris, MD, PhD

    Democritus University of Thrace

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor (Associate) of Democritus University of Thrace

Study Record Dates

First Submitted

January 13, 2022

First Posted

January 26, 2022

Study Start

January 24, 2022

Primary Completion

April 30, 2022

Study Completion

May 31, 2022

Last Updated

July 5, 2023

Record last verified: 2023-06

Locations