Computer Vision SyndromeNCT05545878
Impact of 'SESL01' Lens on Computer Vision Syndrome
A study testing Super enhanced single vision lens 01 for spectacles in people with Computer Vision Syndrome, run by University of Central Lancashire at 1 site in United Kingdom.
Trial summary
The increased use of digital devices such as computers, smart-phones, tablets, and laptops has transformed how people learn and work and has increased the use of screens. This has created visual challenges for some users, such as maintaining a clear vision for a long period even when looking at different devices. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Computer Vision Syndrome
- What is being tested?
- Super enhanced single vision lens 01 for spectacles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2022to 30 Nov 2024
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to provide informed consent
- 21-45 years of age
- Adults diagnosed with CVS: CSV-Q score ≥6
- Participants WITH AND WITHOUT refractive error are acceptable BUT none should have previously worn a "near add" correction (e.g. no previous bifocal/varifocal/enhanced single vision lens [ESL] wear)
- Range of refractive errors should be no more than +4.00 to -6.00 dioptric spherical power (DS) and +2.00 dioptric cylindrical power (DC)
- Must use digital devices for work and/or leisure for at least 1 hour per day (this includes smart-phones, tablets, and laptops but EXCLUDES those using desktop computers only)
Show all 13Show fewer
- Patients MUST have visual symptoms associated with digital device use, e.g. one or more of the following symptoms:
- Tired eyes
- Eye strain
- Blurred vision
- Frontal headaches
- Difficulties keeping clear vision when changing focus from near to distance
- Difficulties keeping clear vision when changing focus from one device to another
Who cannot join
- Lack of capacity to provide informed consent.
- Amblyopia
- Pregnancy
- Diagnosed dry eye disease
- o If a patient develops dry eye symptoms or is diagnosed at follow-up appointments, treatment will be started and assessed in two weeks.
- On anti-depressants (or other medication that can affect accommodation, such as reduced focusing power)
- Any diagnosed ocular pathology (such as glaucoma, corneal dystrophies, lid disorders, and retinal pathologies)
- Change in ±0.75DS/DC in the spectacle prescription
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Eye Health Clinic, University of Central Lancashire
Preston, Lancashire, PR1 2HE
About this study
Official title: Evaluation of the Effectiveness of the Super Enhanced Single Vision Lens L01 (SESL01) in Reducing Symptoms of Computer Vision Syndrome (CVS): a Double-blind Two-arm Parallel Randomised Controlled Trial
The increased use of digital devices such as computers, smart-phones, tablets, and laptops has transformed how people learn and work and has increased the use of screens. This has created visual challenges for some users, such as maintaining a clear vision for a long period even when looking at different devices. Consequently, digital device users can experience eye problems such as blurred vision, eye strain, headaches, and dry eyes. Such problems are more common in people aged 21-45, and it seems that the COVID-19 pandemic has worsened them.
Studies suggest that using specially designed lenses could reduce these problems. Therefore, the investigators aim to study whether specially designed lenses are more effective than standard ones in minimising these problems. The study will be conducted at the University of Central Lancashire at the Preston campus (UK). The study will recruit 300 participants, divided into two equal groups. Participants in group A will receive spectacles with special lenses while group B will receive spectacles with standard lenses. All Participants will be assessed three times, at 4-week intervals, and the final analysis will be performed at 14 weeks. The reduction of the eye problems will be assessed using a validated questionnaire which will produce a score that will be compared between the two groups at the end of the study.
Read more
The study's potential benefits are twofold:
- Patients using the new lenses will hopefully see a reduction in eye problems
- Opticians will provide be able to provide better patient care.
Read the detailed description
Background What is the problem to be addressed? In the last two decades, the way people acquire information has changed dramatically. During that time, engagement with digital devices in developed countries has increased significantly, particularly in the field of mobile media. The increasing use of digital devices showed implications for health, eyes, and vision. A European study found out that by the age of 3, 68% of children regularly use a computer and 54% undertake online activities. In 2016, it was estimated that UK adults typically spend almost 5 hours a day using digital media, with a similar pattern developing in the USA.
The use of digital devices has caused Computer Vision Syndrome (CVS), also called Digital Eye Strain (DES) or Visual Fatigue (VF), which has been well described in the literature for over 20 years.
What is Computer Vision Syndrome? The American Optometric Association defines Computer Vision Syndrome (CVS) as a group of eye and vision-related problems resulting from prolonged exposure to digital/computer devices. CVS has been linked to using a variety of digital devices such as computer/laptop screens, tablets, and smart-phones, which has been steadily growing. The most common symptoms are eye strain, tired eyes, irritation, burning sensation, redness, blurred vision, and double vision. Therefore, a person using digital devices and complaining about one or more of those symptoms might be suffering from CVS. Furthermore, CVS could cause non-ocular symptoms such as headaches and pain in the shoulders, neck, and/or back. Research has identified four CVS categories. The first is asthenopia: eye strain, tired eyes, and dry eyes. The second is ocular and related to eye surface: watery eyes, irritated eyes, contact lens problems. The third is the visual category: blurred vision and slowness of focus. The fourth category is extraocular and is represented by neck, shoulder, and back pain.
CVS symptoms result in poorer visual performance, and even though they are transient, they occur frequently and cause considerable discomfort for sufferers. CVS lowers productivity (increased errors and more frequent breaks) and impinges on job satisfaction and quality of life. Millions of individuals of all ages are at risk of CVS, and according to different studies, the prevalence of CVS ranges from 25% to 93%, depending on the cohort of the studied population, the definition and methodology employed to measure CVS. These results indicate that a large proportion of the population may need treatment for CVS.
CVS affects all age groups, including older age groups (aged 65+), in which the use of technology is also rapidly growing. However, the most affected population are younger users, who are more likely to simultaneously use two or more digital devices. For example, recent US data indicates that while adults aged 60 years and over prefer using laptops and desktop computers, younger adults are more likely to use smart-phones too. Since they use digital devices for work and social purposes (e.g. social media), they often multitask and switch between different devices.
The COVID-19 pandemic introduced homeworking and remote learning and further increased exposure to digital screens. Moreover, lockdown increased unhealthy digital recreational activities, with people turning to television and social media for entertainment.
Management of Computer Vision Syndrome CVS management includes correction of refractive error and/or presbyopia (long-sightedness caused by loss of elasticity of the lens of the eye, occurring typically in middle and old age; managed by prescribing a 'near add'), dry eye management, regular screen breaks, and eye exercises for vergence and accommodative problems (such as a lag in changing the focus from near to far distance). Some studies have explored the role of blue light-filtering spectacle lenses with mixed results, indicating that blue light-filters may not alleviate symptoms of CVS. Given the high prevalence of CVS and near-universal use of digital devices, it is essential that eye care practitioners can provide advice and management options that are evidence based.
Aim To evaluate the effectiveness of the Super Enhanced Single Vision Lens 01 (SESL01) in reducing symptoms of Computer Vision Syndrome.
- Conditions
- Computer Vision Syndrome
- Being tested
- Super enhanced single vision lens 01 for spectacles
- Keywords
- Enhanced, Single, Vision, Spectacle, Lenses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super enhanced single vision lens 01 for spectaclesDevice
This is a spectacle lens designed to have a small amount of positive power towards the bottom of the lens as this is the area that is in line with the eye when downwards for near tasks such as looking at a digital device.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Super enhanced single vision lens 01 for spectacles | Experimental | Participants in the intervention group will wear the newly designed SESL01 lens with anti-reflection coating. Participants will be asked to wear their spectacles for all daily tasks as normal including when looking at digital screens and near tasks. Receives: Device: Super enhanced single vision lens 01 for spectacles |
| Control: Standard single vision lenses with an anti-reflection coating | No intervention | Participants in the control group will be corrected with standard single vision lenses with an anti-reflection coating. Participants will be asked to wear their spectacles for all daily tasks as normal including when looking at digital screens and near tasks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Computer Vision Syndrome Questionnaire (CVS-Q) score.
Is the SESL01 lens effective in reducing the symptoms of the CVS compared with standard single vision lenses, assessed by the reduction in Computer Vision Syndrome Questionnaire (CVS-Q®) scores?
CVS-Q has 16 ocular and visual related symptoms. The frequency of these symptoms is defined based on how often they occur: sometimes or occasionally, once per week, always or often if they occur two to three times per week or every day. The intensity of the symptoms is scored as never=0, mild to moderate=1, severe=2. To measure the frequency of the symptoms, patients will be asked to choose the following options for each of them: never=0, sometimes or occasionally=1, always or often=2. Participants with a total score of 6-12 were deemed to have mild CVS, those with a score of 13-19 moderate, and those with a score ≥20 were considered to have severe CVS
Measured: 16 weeks
Secondary outcomes (1)
Is there an increase in accommodative facility value when using digital devices?
Is the SESL01 lens effective in improving near visual performance when using digital devices, compared with standard single vision lenses, assessed by clinical measurement of accommodative facility using the standard ± 2.00 dioptre spherical lens flippers, measured as cycles per minute.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start1 Dec 2022
- Primary completion28 Aug 2024
- Study completion30 Nov 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blind, randomised controlled trial. Participants will be required to have a full eye exam at the UCLan Eye Health Clinic to assess eligibility to enrol in the study. Once participants have been screened and completed the Computer Vision Syndrome Questionnaire (CVS-Q), ensuring that they meet the inclusion criteria, they will be randomly allocated to the Intervention or Control Groups. After the eye exam and CVS-Q score, eligible participants will have the following tests measured as baseline data:1. LogMAR Vision and Visual Acuity (6/6 minimum monocular distance VA and N6 monocular). 2. Monocular and binocular amplitude of accommodation. 3. Near point of convergence. 4. Wilkins Rate of Reading. 5. Accommodative Facility in cycles per minute. 6. Thomson Clinical Eye Tracking. The tests and CVS-Q will be repeated at intervals of 4 weeks for a further three times. The 4-week interval period will start from the date of the spectacle collection.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Lancashire
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupal Lovell-Patel, University of Central Lancashire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545878
- Sponsor's protocol ID
- Health 0360
- Status last verified
- Jan 2025
- First submitted
- 9 Sep 2022
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Publications
Lovell-Patel R, Ajiboye A, Manfrin A. Evaluation of the effectiveness of the Super Enhanced Single Vision Lens 01 (SESL01) in reducing symptoms of computer vision syndrome (CVS): A study protocol for a double-blind, two-arm parallel randomized controlled trial. Contemp Clin Trials. 2023 Feb;125:107046. doi: 10.1016/j.cct.2022.107046. Epub 2022 Dec 10.
PubMed 36509248
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Super Enhanced Single Vision Lens L01 (SESL01) in Reducing Symptoms of Computer Vision Syndrome (CVS): a Double-blind Two-arm Parallel Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05545878
- Acronym / sponsor ID
- Health 0360
- Conditions
- Computer Vision Syndrome
- Keywords
- Enhanced, Single, Vision, Spectacle, Lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of Central LancashireUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 19 Sep 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 increased use of digital devices such as computers, smart-phones, tablets, and laptops has transformed how people learn and work and has increased the use of screens. This has created visual challenges for some users, such as maintaining a clear vision for a long period even when looking at different devices. Consequently, digital device users can experience eye problems such as blurred vision, eye strain, headaches, and dry eyes. Such problems are more common in people aged 21-45, and it seems that the COVID-19 pandemic has worsened them.
Studies suggest that using specially designed lenses could reduce these problems. Therefore, the investigators aim to study whether specially designed lenses are more effective than standard ones in minimising these problems. The study will be conducted at the University of Central Lancashire at the Preston campus (UK). The study will recruit 300 participants, divided into two equal groups. Participants in group A will receive spectacles with special lenses while group B will receive spectacles with standard lenses. All Participants will be assessed three times, at 4-week intervals, and the final analysis will be performed at 14 weeks. The reduction of the eye problems will be assessed using a validated questionnaire which will produce a score that will be compared between the two groups at the end of the study.
The study's potential benefits are twofold:
- Patients using the new lenses will hopefully see a reduction in eye problems
- Opticians will provide be able to provide better patient care.
Detailed description
Background What is the problem to be addressed? In the last two decades, the way people acquire information has changed dramatically. During that time, engagement with digital devices in developed countries has increased significantly, particularly in the field of mobile media. The increasing use of digital devices showed implications for health, eyes, and vision. A European study found out that by the age of 3, 68% of children regularly use a computer and 54% undertake online activities. In 2016, it was estimated that UK adults typically spend almost 5 hours a day using digital media, with a similar pattern developing in the USA.
The use of digital devices has caused Computer Vision Syndrome (CVS), also called Digital Eye Strain (DES) or Visual Fatigue (VF), which has been well described in the literature for over 20 years.
What is Computer Vision Syndrome? The American Optometric Association defines Computer Vision Syndrome (CVS) as a group of eye and vision-related problems resulting from prolonged exposure to digital/computer devices. CVS has been linked to using a variety of digital devices such as computer/laptop screens, tablets, and smart-phones, which has been steadily growing. The most common symptoms are eye strain, tired eyes, irritation, burning sensation, redness, blurred vision, and double vision. Therefore, a person using digital devices and complaining about one or more of those symptoms might be suffering from CVS. Furthermore, CVS could cause non-ocular symptoms such as headaches and pain in the shoulders, neck, and/or back. Research has identified four CVS categories. The first is asthenopia: eye strain, tired eyes, and dry eyes. The second is ocular and related to eye surface: watery eyes, irritated eyes, contact lens problems. The third is the visual category: blurred vision and slowness of focus. The fourth category is extraocular and is represented by neck, shoulder, and back pain.
CVS symptoms result in poorer visual performance, and even though they are transient, they occur frequently and cause considerable discomfort for sufferers. CVS lowers productivity (increased errors and more frequent breaks) and impinges on job satisfaction and quality of life. Millions of individuals of all ages are at risk of CVS, and according to different studies, the prevalence of CVS ranges from 25% to 93%, depending on the cohort of the studied population, the definition and methodology employed to measure CVS. These results indicate that a large proportion of the population may need treatment for CVS.
CVS affects all age groups, including older age groups (aged 65+), in which the use of technology is also rapidly growing. However, the most affected population are younger users, who are more likely to simultaneously use two or more digital devices. For example, recent US data indicates that while adults aged 60 years and over prefer using laptops and desktop computers, younger adults are more likely to use smart-phones too. Since they use digital devices for work and social purposes (e.g. social media), they often multitask and switch between different devices.
The COVID-19 pandemic introduced homeworking and remote learning and further increased exposure to digital screens. Moreover, lockdown increased unhealthy digital recreational activities, with people turning to television and social media for entertainment.
Management of Computer Vision Syndrome CVS management includes correction of refractive error and/or presbyopia (long-sightedness caused by loss of elasticity of the lens of the eye, occurring typically in middle and old age; managed by prescribing a 'near add'), dry eye management, regular screen breaks, and eye exercises for vergence and accommodative problems (such as a lag in changing the focus from near to far distance). Some studies have explored the role of blue light-filtering spectacle lenses with mixed results, indicating that blue light-filters may not alleviate symptoms of CVS. Given the high prevalence of CVS and near-universal use of digital devices, it is essential that eye care practitioners can provide advice and management options that are evidence based.
Aim To evaluate the effectiveness of the Super Enhanced Single Vision Lens 01 (SESL01) in reducing symptoms of Computer Vision Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a double-blind, randomised controlled trial. Participants will be required to have a full eye exam at the UCLan Eye Health Clinic to assess eligibility to enrol in the study. Once participants have been screened and completed the Computer Vision Syndrome Questionnaire (CVS-Q), ensuring that they meet the inclusion criteria, they will be randomly allocated to the Intervention or Control Groups. After the eye exam and CVS-Q score, eligible participants will have the following tests measured as baseline data:1. LogMAR Vision and Visual Acuity (6/6 minimum monocular distance VA and N6 monocular). 2. Monocular and binocular amplitude of accommodation. 3. Near point of convergence. 4. Wilkins Rate of Reading. 5. Accommodative Facility in cycles per minute. 6. Thomson Clinical Eye Tracking. The tests and CVS-Q will be repeated at intervals of 4 weeks for a further three times. The 4-week interval period will start from the date of the spectacle collection.
| Arm | Type | Receives |
|---|---|---|
| Intervention: Super enhanced single vision lens 01 for spectacles | Experimental | Device: Super enhanced single vision lens 01 for spectaclesParticipants in the intervention group will wear the newly designed SESL01 lens with anti-reflection coating. Participants will be asked to wear their spectacles for all daily tasks as normal including when looking at digital screens and near tasks. |
| Control: Standard single vision lenses with an anti-reflection coating | No intervention | –Participants in the control group will be corrected with standard single vision lenses with an anti-reflection coating. Participants will be asked to wear their spectacles for all daily tasks as normal including when looking at digital screens and near tasks. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Able to provide informed consent
- 21-45 years of age
- Adults diagnosed with CVS: CSV-Q score ≥6
- Participants WITH AND WITHOUT refractive error are acceptable BUT none should have previously worn a "near add" correction (e.g. no previous bifocal/varifocal/enhanced single vision lens [ESL] wear)
- Range of refractive errors should be no more than +4.00 to -6.00 dioptric spherical power (DS) and +2.00 dioptric cylindrical power (DC)
Key exclusion criteria (8 listed)
- Lack of capacity to provide informed consent.
- Amblyopia
- Pregnancy
- Diagnosed dry eye disease
- o If a patient develops dry eye symptoms or is diagnosed at follow-up appointments, treatment will be started and assessed in two weeks.
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 |
|---|---|---|
| Super enhanced single vision lens 01 for spectaclesThis is a spectacle lens designed to have a small amount of positive power towards the bottom of the lens as this is the area that is in line with the eye when downwards for near tasks such as looking at a digital device. | Device | Intervention: Super enhanced single vision lens 01 for spectacles |
Primary outcome
Reduction in Computer Vision Syndrome Questionnaire (CVS-Q) score.
Time frame: 16 weeks
Is the SESL01 lens effective in reducing the symptoms of the CVS compared with standard single vision lenses, assessed by the reduction in Computer Vision Syndrome Questionnaire (CVS-Q®) scores? CVS-Q has 16 ocular and visual related symptoms. The frequency of these symptoms is defined based on how often they occur: sometimes or occasionally, once per week, always or often if they occur two to three times per week or every day. The intensity of the symptoms is scored as never=0, mild to moderate=1, severe=2. To measure the frequency of the symptoms, patients will be asked to choose the following options for each of them: never=0, sometimes or occasionally=1, always or often=2. Participants with a total score of 6-12 were deemed to have mild CVS, those with a score of 13-19 moderate, and those with a score ≥20 were considered to have severe CVS
1 secondary outcome
Is there an increase in accommodative facility value when using digital devices?
Time frame: 16 weeks
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 3 Jan 2025.
- Derived from this study: PubMed 36509248Lovell-Patel R, Ajiboye A, Manfrin A. Evaluation of the effectiveness of the Super Enhanced Single Vision Lens 01 (SESL01) in reducing symptoms of computer vision syndrome (CVS): A study protocol for a double-blind, two-arm parallel randomized controlled trial. Contemp Clin Trials. 2023 Feb;125:107046. doi: 10.1016/j.cct.2022.107046. Epub 2022 Dec 10.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Super enhanced single vision lens 01 for spectacles in people with Computer Vision Syndrome, run by University of Central Lancashire at 1 site in United Kingdom.
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 13 inclusion and 8 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 3 Jan 2025. 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 United Kingdom. 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?
Reduction in Computer Vision Syndrome Questionnaire (CVS-Q) score. (time frame: 16 weeks). 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 NCT05545878, 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 3 Jan 2025.