Computer Vision SyndromeNCT04398212
Computer Vision Syndrome Visual Sequelae
A study testing mfERG (multifocal-retinogram) in people with Computer Vision Syndrome, run by Sohag University at 1 site in Egypt.
Trial summary
the university students will respond to CVS-F3 survey form and then they will be subjected to complete ophthalmic examination and investigations Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Computer Vision Syndrome
- What is being tested?
- mfERG (multifocal-retinogram)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 733 participants
- Where
- 1 siteEgypt
- Study dates
- 21 May 2018to 1 Aug 2020
- Phase
- Interventional
- 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
Who may be able to join
- University students
Who cannot join
- Amblyopia
- Anisometropia
- strabismus
- Previous eye surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Visual and Ocular Sequelae of Computer Vision Syndrome: A Randomized Controlled Trial
the university students will respond to CVS-F3 survey form and then they will be subjected to complete ophthalmic examination and investigations
Read the detailed description
CVS-F3 is a survey form consisted of up to 30 questions regarding Computer Vision Syndrome (CVS) complains, thereafter a randomized sample of students will be subjected to complete ophthalmic examination including visual acuity and refractive measurements, intraocular pressure measurements, Slitlamp and fungus examinations, mfERG examinations. the sudents will be requested to decrease their screen time and the examinations will be repeated one month later.
- Conditions
- Computer Vision Syndrome
- Being tested
- mfERG (multifocal-retinogram)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mfERG (multifocal-retinogram)Diagnostic test
mfERG will be performed for the students to document the effect of CVS on retina
| Study group | Role | What they receive |
|---|---|---|
| Non-complaining group | Placebo comparator | the students in this group are not complaining of CVS symptoms but will be examined to diagnose CVS or exclude it Receives: Diagnostic Test: mfERG (multifocal-retinogram) |
| Complaining group | Experimental | the students in this group are complaining of CVS symptoms but will be examined to document their complains and correlate to clinical findings Receives: Diagnostic Test: mfERG (multifocal-retinogram) |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
visual changes i.e. uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) using logMAR measurements following reduction of screen time
Measured: 1 month
near vision
near vision changes following reduction of screen hours using card test, near visual acuity chart and near point test while the measurements will be diopters and lines of near chart
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start21 May 2018
- Primary completion15 Jun 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 733 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, MD. PhP, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398212
- Sponsor's protocol ID
- 5-10/4/2018
- Status last verified
- Aug 2020
- First submitted
- 18 May 2020
- Last updated
- 10 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual and Ocular Sequelae of Computer Vision Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04398212
- Acronym / sponsor ID
- 5-10/4/2018
- Conditions
- Computer Vision Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 733 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 21 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.
the university students will respond to CVS-F3 survey form and then they will be subjected to complete ophthalmic examination and investigations
Detailed description
CVS-F3 is a survey form consisted of up to 30 questions regarding Computer Vision Syndrome (CVS) complains, thereafter a randomized sample of students will be subjected to complete ophthalmic examination including visual acuity and refractive measurements, intraocular pressure measurements, Slitlamp and fungus examinations, mfERG examinations. the sudents will be requested to decrease their screen time and the examinations will be repeated one month later.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-complaining group | Placebo comparator | Diagnostic Test: mfERG (multifocal-retinogram)the students in this group are not complaining of CVS symptoms but will be examined to diagnose CVS or exclude it |
| Complaining group | Experimental | Diagnostic Test: mfERG (multifocal-retinogram)the students in this group are complaining of CVS symptoms but will be examined to document their complains and correlate to clinical findings |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- University students
Key exclusion criteria (4 listed)
- Amblyopia
- Anisometropia
- strabismus
- Previous eye surgery
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 |
|---|---|---|
| mfERG (multifocal-retinogram)mfERG will be performed for the students to document the effect of CVS on retina | Diagnostic test | Complaining group, Non-complaining group |
Primary outcome
visual acuity
Time frame: 1 month
visual changes i.e. uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) using logMAR measurements following reduction of screen time
near vision
Time frame: 1 month
near vision changes following reduction of screen hours using card test, near visual acuity chart and near point test while the measurements will be diopters and lines of near 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 10 Aug 2020.
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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, MD. PhP principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mfERG (multifocal-retinogram) in people with Computer Vision Syndrome, run by Sohag University at 1 site 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 1 inclusion and 4 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 10 Aug 2020. 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 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. Some participants in this study may receive a placebo. 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?
visual acuity (time frame: 1 month). The study lists 2 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 10 Aug 2020.