Visual AcuityNCT05209581
Assessment of Visual Acuity in Refugee Population
An observational study of Visual Acuity and Refractive Errors, run by Democritus University of Thrace at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity, Refractive Errors, Low Vision
- What is being tested?
- Distance Visual Acuity Examination
- How many people
- 330 participants
- Where
- 1 siteGreece
- Study dates
- 24 Jan 2022to 31 May 2022
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal- and low-vision adult refugees or immigrants living in accommodation structures
Who may be able to join
- Adult refugees or immigrants
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Visual Acuity of the 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:
- 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).
Read the 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.
- Conditions
- Visual Acuity, Refractive Errors, Low Vision, Vision Disorders
- Being tested
- Distance Visual Acuity Examination
- Keywords
- distance visual acuity, refugee, immigrant
- Medical subject headings
- Refractive Errors, Vision, Low, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distance Visual Acuity ExaminationDiagnostic test
Best spectacle-corrected distance visual acuity of refugees/immigrants will be examined via a web-based digital visual acuity chart
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Adult refugees/immigrants living in accommodation structures Receives: Diagnostic Test: Distance Visual Acuity Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start24 Jan 2022
- Primary completion30 Apr 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual AcuityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Labiris, Democritus University of Thrace
- Investigators
- Georgios Labiris, MD, PhD, Study chair, Democritus University of Thrace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209581
- Sponsor's protocol ID
- DUTh REC/4/16-12-2021
- Status last verified
- Jun 2023
- First submitted
- 13 Jan 2022
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Visual Acuity of the Refugee Population
- ClinicalTrials.gov ID
- NCT05209581
- Acronym / sponsor ID
- DUTh REC/4/16-12-2021
- Conditions
- Visual Acuity, Refractive Errors, Low Vision, Vision Disorders
- Keywords
- distance visual acuity, refugee, immigrant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Diagnostic Test: Distance Visual Acuity ExaminationAdult refugees/immigrants living in accommodation structures |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal- and low-vision adult refugees or immigrants living in accommodation structures
Key inclusion criteria (1 listed)
- Adult refugees or immigrants
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distance Visual Acuity ExaminationBest spectacle-corrected distance visual acuity of refugees/immigrants will be examined via a web-based digital visual acuity chart | Diagnostic test | Study Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgios Labiris, MD, PhD study chair
Democritus University of Thrace
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Acuity and Refractive Errors, run by Democritus University of Thrace at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best spectacle-corrected distance visual acuity (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.