Computer Vision SyndromeNCT04405648
Computer Vision Syndrome Prevalence Among University Students
An observational study of Computer Vision Syndrome, run by Sohag University at 2 sites in Egypt.
Trial summary
CVS-F3 questionnaire will be used as an instrument to survey CVS prevalence and severity among medical students Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Computer Vision Syndrome
- What is being tested?
- CVS GROUP
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 49 participants
- Where
- 2 sitesEgypt
- Study dates
- 28 May 2020to 31 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: medical students who are using screens in their medical studies or personal lives and how these screens affect their medical studies and the effect of mandated medical computer use if present on their screen-behaviour and associated risk factor
Who may be able to join
- university students
- studying medicine
Who cannot join
- ocular surgery
- amblyopia
- anisometropia
- strabismus
- DM
- hypertension
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of medicine
Sohag, 82425
Sohag Faculty of Medicine
Sohag, 82425
About this study
Official title: Prevalence and Severity of Computer Vision Syndrome Among Medical Students
CVS-F3 questionnaire will be used as an instrument to survey CVS prevalence and severity among medical students
Read the detailed description
CVS-F3 is a valid questionnaire that includes 26 questions to be responded by the medical students to detect CVS complains and possible complications. The questionnaire includes questions regarding potential ocular, extra-ocular, musclo-skeletal and neuro-psychatric complains caused by CVS. Complete statistical analysis of the survey data will be done using univariate and multivariate logistic and linear regression analysis.
- Conditions
- Computer Vision Syndrome
- Being tested
- CVS GROUP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVS GROUPBehavioural
the students will respond to CVS-F3 questionnaire to report their potential CVS complains and associated screen factors as screen-time, screen-size, screen-resolution and other factors.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of CVS
will be reorted in form of percentage (%) of students with CVS
Measured: 1 month
Visual acuity
measurement of visual acuity using distance visual charts in logMAR measurements
Measured: 1 month
Refraction
measurement of refractive power in diopters
Measured: 1 month
Schirmer test
measurement of tear volume production with Schirmer test in mm unit measurements
Measured: 1 month
Tear Break Up Time (TBUT)
measurement of tear film stability with TBUT in seconds time unit measurements
Measured: 1 month
mfERG examinations
mfERG will be performed for the students to document the effect of CVS on retina
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start28 May 2020
- Primary completion20 Oct 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Computer Vision SyndromeStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Mohammed Iqbal, Sohag University
- Investigators
- Mohammed Iqbal, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405648
- Sponsor's protocol ID
- 4-8/1/2018
- Status last verified
- Dec 2022
- First submitted
- 24 May 2020
- Last updated
- 22 Dec 2022
- Results posted
- No
- FDA-regulated device
- No
Publications
Iqbal M, Soliman A, Ibrahim O, Gad A. Analysis of the Outcomes of the Screen-Time Reduction in Computer Vision Syndrome: A Cohort Comparative Study. Clin Ophthalmol. 2023 Jan 7;17:123-134. doi: 10.2147/OPTH.S399044. eCollection 2023.
PubMed 36644605
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Severity of Computer Vision Syndrome Among Medical Students
- ClinicalTrials.gov ID
- NCT04405648
- Acronym / sponsor ID
- 4-8/1/2018
- Conditions
- Computer Vision Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 28 May 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 May 2020 (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.
CVS-F3 questionnaire will be used as an instrument to survey CVS prevalence and severity among medical students
Detailed description
CVS-F3 is a valid questionnaire that includes 26 questions to be responded by the medical students to detect CVS complains and possible complications. The questionnaire includes questions regarding potential ocular, extra-ocular, musclo-skeletal and neuro-psychatric complains caused by CVS. Complete statistical analysis of the survey data will be done using univariate and multivariate logistic and linear regression analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- medical students who are using screens in their medical studies or personal lives and how these screens affect their medical studies and the effect of mandated medical computer use if present on their screen-behaviour and associated risk factor
Key inclusion criteria (2 listed)
- university students
- studying medicine
Key exclusion criteria (6 listed)
- ocular surgery
- amblyopia
- anisometropia
- strabismus
- DM
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 |
|---|---|---|
| CVS GROUPthe students will respond to CVS-F3 questionnaire to report their potential CVS complains and associated screen factors as screen-time, screen-size, screen-resolution and other factors. | Behavioural | – |
Primary outcome
Prevalence of CVS
Time frame: 1 month
will be reorted in form of percentage (%) of students with CVS
Visual acuity
Time frame: 1 month
measurement of visual acuity using distance visual charts in logMAR measurements
Refraction
Time frame: 1 month
measurement of refractive power in diopters
Schirmer test
Time frame: 1 month
measurement of tear volume production with Schirmer test in mm unit measurements
Tear Break Up Time (TBUT)
Time frame: 1 month
measurement of tear film stability with TBUT in seconds time unit measurements
mfERG examinations
Time frame: 6 months
mfERG will be performed for the students to document the effect of CVS on retina
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 22 Dec 2022.
- Derived from this study: PubMed 36644605Iqbal M, Soliman A, Ibrahim O, Gad A. Analysis of the Outcomes of the Screen-Time Reduction in Computer Vision Syndrome: A Cohort Comparative Study. Clin Ophthalmol. 2023 Jan 7;17:123-134. doi: 10.2147/OPTH.S399044. eCollection 2023.
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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.
Mohammed Iqbal principal investigator
Sohag University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Computer Vision Syndrome, run by Sohag University at 2 sites in Egypt.
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 2 inclusion and 6 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 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Prevalence of CVS (time frame: 1 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04405648, which also lists 1 linked publication.
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 22 Dec 2022.