AzTrials
AzTrials

Computer Vision SyndromeNCT06106347

Analysis of Visual and Ocular Outcomes of Computer Vision Syndrome

An observational study of Computer Vision Syndrome, run by Sohag University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The digital technology is universal and has spread worldwide; thus, digital behaviour has dramatically changed peoples' lifestyles. Previous studies have reported that individuals interact with digital screens for up to 12 hours daily,1,2 and the American Optometric Association defined a combination of ocular and… Read more about this study

Who is it for?
Ages 20 to 30 years
Conditions the study is for
Computer Vision Syndrome
What is being tested?
mfERG device (RETIscan; Roland Instruments, Wiesbaden, Germany)
Type of treatment
Medical device
How many people
60 participants
Where
1 siteEgypt
Study dates
15 Oct 2023to 15 Oct 2024
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 20 to 30 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: include university students and young staff members, 20-30 years old who were spending more than 3 screen-hours daily on average over the last 3 years.

Who may be able to join

  • include university students and young staff members, 20-30 years old who were spending more than 3 screen-hours daily on average over the last 3 years.

Who cannot join

  • include amblyopia; strabismus; anisometropia; refractive errors higher than 4 D myopia, 4 D hyperopia, or 4 D astigmatism; difference between subjective and cycloplegic refraction >1D; and previous or current systemic or eye disease or surgery.

Trial locations and contacts

1 site in 1 country.

Mostafa R Refaee, Resident contact

01125795711

refatsasa3@gmail.com

Mohammed I Hafaz, Professor contact

Egypt1 site, 1 recruiting
  • Sohag University hospitals

    Sohag

    Magdy M Amin, Professor

    Recruiting

Other trials in Egypt

About this study

The digital technology is universal and has spread worldwide; thus, digital behaviour has dramatically changed peoples' lifestyles. Previous studies have reported that individuals interact with digital screens for up to 12 hours daily,1,2 and the American Optometric Association defined a combination of ocular and extraocular symptoms that affects the screen users as computer vision syndrome (CVS).3 However, our current understanding of digital technology and its harmful impact on the eye and public health,1,4,5 visual performance,6-8 sleep patterns,7,8 circadian rhythms,5,8 musculoskeletal system activities,3,4 and underlying physiological mechanisms9 remains incomplete and is associated with misconceptions.1 Therefore, educational programs that include protective measures and health campaigns are necessary.10 Computer vision syndrome (CVS) is also called with other names as digital eye strain (DES),3 occupational asthenopia, digital asthenopia,1 and video display terminal syndrome (VDTS). CVS ocular symptoms include visual blur with an underlying mechanism that is not fully understood,10 dry eye disease (DED),3 eye redness and irritation, eyestrain, fatigue, discomfort, difficulty in refocusing the eyes, and diplopia.3,4. CVS extraocular symptoms include headache, sleep disturbances, depression,7,8 musculoskeletal aches, such as neck/shoulder/back pain, difficulty in writing or holding objects, pain in thumbs, fingers, or wrists because of tendonitis and/or arthritis.

Smartphones are used extensively worldwide by people of all ages, and have close-viewing distance, related high-definition resolution, thousands of time-consuming applications and games in stores, and 24/7 Internet connectivity.

The decline in visual acuity observed in CVS can be attributed to the screen-induced foveal dysfunction11-13 which is a phenomenon that has been extensively documented in the literature using multifocal electroretinogram (mfERG) examinations. Previous studies11-13 consistently reported the presence of this dysfunction, which has been linked to prolonged exposure to digital screens emitting blue light. Notably, recent research has demonstrated noteworthy improvements in foveal responses following a strict reduction in screen time for duration of four weeks.13 These improvements were found to correspond with enhanced visual performances, indicating a positive relationship between the reversal of screen-induced foveal dysfunction and visual outcomes. These findings highlight the reversible nature of screen-induced foveal dysfunction and its potential impact on visual acuity. They support the notion that reducing screen time can serve as an effective intervention strategy, leading to substantial improvements in both foveal responses and overall visual performance.13 The computer vision syndrome questionnaire (CVS-Q) is a self-administered scale that evaluates the frequency and intensity of 16 ocular and visual symptoms related to the use of digital devices. The scoring of the questionnaire follows the procedure of the original version. The 16 items (CVS-symptoms) are scored with two rating scales: one for frequency (never, occasionally, often, or always), and one for intensity (moderate, intense). The responses to the two rating scales for each item are combined multiplicatively into a single scale called symptom severity, and the result should be recoded as 0 = 0; 1 or 2 = 1; 4 = 2. If the total score is ≥ 6 points, the worker is considered to suffer computer vision syndrome .14 Ocular surface disease index is a quick self-assessment questionnaire of the symptoms of ocular irritation in dry eye disease (DED) and how they affect functioning related to vision. This 12-item questionnaire assesses dry eye symptoms and the effect it has on vision-related function in the past week of the patient's life.15 The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time." A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.15 DED, also known as keratoconjunctivitis sicca, is the condition of having dry eyes. Symptoms include dryness in the eye, irritation, redness, discharge, blurred vision, and easily fatigued eyes. Symptoms range from mild and occasional to severe and continuous. DED can lead to blurred vision, instability of the tear film, increased risk of damage to the ocular surface such as scaring of the cornea, and changes in the eye including the neurosensory system.16

Being tested
mfERG device (RETIscan; Roland Instruments, Wiesbaden, Germany)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mfERG device (RETIscan; Roland Instruments, Wiesbaden, Germany)Device

    physiological macular function

Study groups in NCT06106347
Study groupRoleWhat they receive
CVS grouppositive CVS diagnosis
Receives: Device: mfERG device (RETIscan; Roland Instruments, Wiesbaden, Germany)
controlparticipants with no-CVS diagnosis
Receives: Device: mfERG device (RETIscan; Roland Instruments, Wiesbaden, Germany)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. nV/deg2

    physiological macular function

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2023
  2. Study start15 Oct 2023
  3. Primary completion15 Oct 2024 (estimated)
  4. Study completion15 Oct 2024 (estimated)

Resources

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
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06106347
Sponsor's protocol ID
Soh-Med-23-10-02MS
Status last verified
Oct 2023
First submitted
24 Oct 2023
Last updated
30 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Vaz FT, Henriques SP, Silva DS, Roque J, Lopes AS, Mota M. Digital Asthenopia: Portuguese Group of Ergophthalmology Survey. Acta Med Port. 2019 Apr 30;32(4):260-265. doi: 10.20344/amp.10942. Epub 2019 Apr 30.

    PubMed 31067419
  • Ahmed SF, McDermott KC, Burge WK, Ahmed IIK, Varma DK, Liao YJ, Crandall AS, Khaderi SKR. Visual function, digital behavior and the vision performance index. Clin Ophthalmol. 2018 Dec 10;12:2553-2561. doi: 10.2147/OPTH.S187131. eCollection 2018.

    PubMed 30573945
  • Iqbal M, Said O, Ibrahim O, Soliman A. Visual Sequelae of Computer Vision Syndrome: A Cross-Sectional Case-Control Study. J Ophthalmol. 2021 Apr 2;2021:6630286. doi: 10.1155/2021/6630286. eCollection 2021.

    PubMed 33868724
  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of 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 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: status not confirmed, as of the sponsor's last update on 30 Oct 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mostafa R Refaee, Resident (01125795711, refatsasa3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

nV/deg2 (time frame: 12 months). 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 NCT06106347, which also lists 4 linked publications.

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 30 Oct 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in