Assessment of Visual Acuity in Refugee Population | NCT05209581

Studies
Assessment of Visual Acuity in Refugee Population

NCT05209581

Sponsor

Democritus University of Thrace

Status

Completed

Last Update Posted

Jul 5, 2023Actual

Enrollment

330Actual

Phase

Not provided

Conditions

Visual Acuity
Refractive Errors
Low Vision
Vision Disorders

Interventions

Distance Visual Acuity Examination

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 24, 2022Actual

Primary Completion Date

Apr 30, 2022Actual

Completion Date

May 31, 2022Actual

First Submitted Date

Jan 13, 2022

First Submission Date that Met QC Criteria

Jan 13, 2022

First Posted Date

Jan 26, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2023

Last Update Posted Date

Jul 5, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Georgios Labiris, Professor (Associate) of Democritus University of Thrace, Democritus University of ThracePrincipal Investigator

Lead Sponsor

Democritus University of ThraceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Week

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

330Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group		Adult refugees/immigrants living in accommodation structures	Diagnostic Test: Distance Visual Acuity Examination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Georgios Labiris, MD, PhD	Democritus University of Thrace	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Democritus University of Thrace		Alexandroupoli	Evros	68100	Greece

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012030	Refractive Errors
D015354	Vision, Low
D014786	Vision Disorders

Ancestor Terms

ID	Term
D005128	Eye Diseases
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided