Impact of 'SESL01' Lens on Computer Vision Syndrome (NCT05545878) | Clinical Trial Compass
CompletedNot Applicable
Impact of 'SESL01' Lens on Computer Vision Syndrome
United Kingdom125 participantsStarted 2022-12-01
Plain-language 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. 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:
1. Patients using the new lenses will hopefully see a reduction in eye problems
2. Opticians will provide be able to provide better patient care.
Who can participate
Age range
21 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
* 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
Exclusion Criteria:
* 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 i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction in Computer Vision Syndrome Questionnaire (CVS-Q) score.