Impact of 'SESL01' Lens on Computer Vision Syndrome

NCT05545878 | Completed

• 1 other identifier: Health 0360
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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. 1.Patients using the new lenses will hopefully see a reduction in eye problems
2. 2.Opticians will provide be able to provide better patient care.

Conditions

Computer Vision Syndrome

Keywords

Enhanced; Single; Vision; Spectacle; Lenses

Outcome Measures

Primary Outcomes (1)

• 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

  16 weeks

Secondary Outcomes (1)

• Is there an increase in accommodative facility value when using digital devices?

  16 weeks

Study Arms (2)

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.

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.

Interventions

Super enhanced single vision lens 01 for spectacles DEVICE

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.

Intervention: Super enhanced single vision lens 01 for spectacles

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to provide informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Central Lancashire: lead

Study Sites (1)

Eye Health Clinic, University of Central Lancashire

Preston, Lancashire, PR1 2HE, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36509248 DERIVED

MeSH Terms

Interventions

Eyeglasses

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The procedure adopted in this study for assuring the allocation concealment will be the use of sequentially numbered, opaque, and sealed envelopes (SNOSE). Blinding : In our study, the clinicians (opticians) performing the assessment and follow-up and the patients receiving and wearing the spectacles will be blinded to the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 19, 2022
• Study Start: December 1, 2022
• Primary Completion: August 28, 2024
• Study Completion: November 30, 2024
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)