Eye DiseasesNCT04960696
Effect on Ocular Surface Symptoms of Online Education
An observational study of Eye Diseases and Ocular Surface Disease, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
retrospective, observational study. Read more about this study
- Who is it for?
- Ages 6 to 30 years
- Conditions the study is for
- Eye Diseases, Ocular Surface Disease, Dry Eye
- What is being tested?
- OSDI, tear break up time and schirmer
- How many people
- 315 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Apr 2021to 20 Jun 2021
- How long will I take part?
- 1 Day
- 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 6 to 30 years
- All sexes
- Child, Adult
Study population: Students aged 6-30 who receive online education during the pandemic period
Who may be able to join
- Online education >6 years <30 years student
Who cannot join
- not student not taking online education <6 years >30 years
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Abdullah Beyoğlu
Kahramanmaraş, In the USA Or Canada, Please Select..., 46040
About this study
Official title: An Evaluation of the Effect on Ocular Surface Symptoms of Online Education During the Pandemic
retrospective, observational study.
Read the detailed description
Aim: The aim of this study was to investigate the effects on ocular surface symptoms of students taking online education, which was a part of the distance learning model during the COVID-19 pandemic, to be able to prevent the formation of irreversible damage with early diagnosis and treatment. With recommendations that can be simply applied, it was aimed to protect ocular health.
Material and Method: The study included 315 students who were undertaking online education and presented at the Ophthalmology Department of a tertiary level university hospital. A record was made of sociodemographic data, Schirmer test results, tear break-up time (TBUT) measurements, and Ocular Surface Disease Index (OSDI) scores. The data were analyzed statistically using SPSS vn. 22.0 software, and a value of p<0.05 was accepted as statistically significant.
- Conditions
- Eye Diseases, Ocular Surface Disease, Dry Eye
- Being tested
- OSDI, tear break up time, schirmer
- Keywords
- Pandemic, online education, ocular health, tear break up time, schirmer
- Medical subject headings
- Eye Diseases, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSDIDiagnostic test
Change of OSDI in distance education
tear break up timeDiagnostic test
Change of tear break up time in distance education
schirmerDiagnostic test
Change of schirmer in distance education
| Study group | Role | What they receive |
|---|---|---|
| primary school/78 subjects | Determining the negative effects of distance education on eye symptoms during the pandemic period. Receives: Diagnostic Test: OSDI; Diagnostic Test: tear break up time; Diagnostic Test: schirmer | |
| middle school/78 subjects | Determining the negative effects of distance education on eye symptoms during the pandemic period. Receives: Diagnostic Test: OSDI; Diagnostic Test: tear break up time; Diagnostic Test: schirmer | |
| high school/78 subjects | Determining the negative effects of distance education on eye symptoms during the pandemic period. Receives: Diagnostic Test: OSDI; Diagnostic Test: tear break up time; Diagnostic Test: schirmer | |
| university/81 subjects | Determining the negative effects of distance education on eye symptoms during the pandemic period. Receives: Diagnostic Test: OSDI; Diagnostic Test: tear break up time; Diagnostic Test: schirmer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dry eye symptom scale: ocular symptom scale index (OSDI)
Change of OSDI in distance education
Measured: baseline
Dry eye symptom scale:Tear break up time (TBUT)
Change of tear break up time in distance education
Measured: baseline
Dry eye scale:Schirmer
Change of Schirmer in distance education
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start14 Apr 2021
- Primary completion15 Jun 2021
- Study completion20 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies 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
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 315 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Beyoğlu, Kahramanmaras Sutcu Imam University
- Investigators
- Abdullah Beyoğlu, Study chair, Kahramanmaraş Sütçü İmam Üniversitesi Tıp Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960696
- Sponsor's protocol ID
- desicion:06, dated: 12/04/21
- Status last verified
- Jul 2021
- First submitted
- 29 Jun 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effect on Ocular Surface Symptoms of Online Education During the Pandemic
- ClinicalTrials.gov ID
- NCT04960696
- Acronym / sponsor ID
- desicion:06, dated: 12/04/21
- Conditions
- Eye Diseases, Ocular Surface Disease, Dry Eye
- Keywords
- Pandemic, online education, ocular health, tear break up time, schirmer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 14 Jul 2021 (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.
retrospective, observational study.
Detailed description
Aim: The aim of this study was to investigate the effects on ocular surface symptoms of students taking online education, which was a part of the distance learning model during the COVID-19 pandemic, to be able to prevent the formation of irreversible damage with early diagnosis and treatment. With recommendations that can be simply applied, it was aimed to protect ocular health.
Material and Method: The study included 315 students who were undertaking online education and presented at the Ophthalmology Department of a tertiary level university hospital. A record was made of sociodemographic data, Schirmer test results, tear break-up time (TBUT) measurements, and Ocular Surface Disease Index (OSDI) scores. The data were analyzed statistically using SPSS vn. 22.0 software, and a value of p<0.05 was accepted as statistically significant.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| primary school/78 subjects | – | Diagnostic Test: OSDI, Diagnostic Test: tear break up time, Diagnostic Test: schirmerDetermining the negative effects of distance education on eye symptoms during the pandemic period. |
| middle school/78 subjects | – | Diagnostic Test: OSDI, Diagnostic Test: tear break up time, Diagnostic Test: schirmerDetermining the negative effects of distance education on eye symptoms during the pandemic period. |
| high school/78 subjects | – | Diagnostic Test: OSDI, Diagnostic Test: tear break up time, Diagnostic Test: schirmerDetermining the negative effects of distance education on eye symptoms during the pandemic period. |
| university/81 subjects | – | Diagnostic Test: OSDI, Diagnostic Test: tear break up time, Diagnostic Test: schirmerDetermining the negative effects of distance education on eye symptoms during the pandemic period. |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Students aged 6-30 who receive online education during the pandemic period
Key inclusion criteria (1 listed)
- Online education >6 years <30 years student
Key exclusion criteria (1 listed)
- not student not taking online education <6 years >30 years
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 |
|---|---|---|
| OSDIChange of OSDI in distance education | Diagnostic test | high school/78 subjects, middle school/78 subjects, primary school/78 subjects, university/81 subjects |
| tear break up timeChange of tear break up time in distance education | Diagnostic test | high school/78 subjects, middle school/78 subjects, primary school/78 subjects, university/81 subjects |
| schirmerChange of schirmer in distance education | Diagnostic test | high school/78 subjects, middle school/78 subjects, primary school/78 subjects, university/81 subjects |
Primary outcome
Dry eye symptom scale: ocular symptom scale index (OSDI)
Time frame: baseline
Change of OSDI in distance education
Dry eye symptom scale:Tear break up time (TBUT)
Time frame: baseline
Change of tear break up time in distance education
Dry eye scale:Schirmer
Time frame: baseline
Change of Schirmer in distance education
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 14 Jul 2021.
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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.
Abdullah Beyoğlu study chair
Kahramanmaraş Sütçü İmam Üniversitesi Tıp Fakültesi
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 Eye Diseases and Ocular Surface Disease, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
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 1 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 14 Jul 2021. 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 Turkey (Türkiye). 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?
Dry eye symptom scale: ocular symptom scale index (OSDI) (time frame: baseline). The study lists 3 primary outcomes in all. 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 14 Jul 2021.