MyopiaNCT06739525
Effects of Blue of Glasses VS Standard Lenses on Contrast Sensitivity & Visual Fatigue in Myopic & Non-Myopic Adults
A study testing Blue Light-Blocking Glasses (Intervention Group) in people with Myopia, run by Superior University at 1 site in Pakistan.
Trial summary
This study investigates the effects of blue light-blocking glasses compared to standard lenses on contrast sensitivity and visual fatigue in myopic and non-myopic adults. With the growing use of digital screens, blue light exposure has raised concerns due to potential eye strain, sleep disruption, and visual fatigue. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Blue Light-Blocking Glasses (Intervention Group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Feb 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18-50 years.
- Both myopic (with any degree of myopia) and non-myopic adults.
- Participants who use computer screens for at least four hours per day.
- Individuals currently using corrective lenses or willing to wear study-provided glasses during the experiment.
- Individuals willing to complete the study protocol, which includes attending follow-up examinations and filling out visual fatigue questionnaires.
Who cannot join
- A history of any serious vision-related condition (such as glaucoma, cataracts, or retinal problems).
- Individuals who have already undergone refractive surgery (e.g., LASIK) or other types of eye surgery.
- Systemic conditions affecting vision include diabetes, neurological problems, and any other ailment that may impair visual ability.
- Taking drugs that are known to impair vision or produce visual tiredness (for example, certain antihistamines and antidepressants).
- Pregnant women's visual performance may be affected by hormonal changes.
- People with uncorrected vision difficulties cannot use the prescription lenses during study time.
- Participants who are allergic or sensitive to lens materials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Blue of Blue Light-blocking Glasses Versus Standard Lenses on Contrast Sensitivity & Visual Fatigue in Myopic & Non-Myopic Adults
This study investigates the effects of blue light-blocking glasses compared to standard lenses on contrast sensitivity and visual fatigue in myopic and non-myopic adults. With the growing use of digital screens, blue light exposure has raised concerns due to potential eye strain, sleep disruption, and visual fatigue.
Read the detailed description
While blue light-blocking lenses are marketed to address these issues, evidence of their efficacy, particularly for different refractive errors like myopia, remains inconclusive. Using a randomized controlled design, this study will assess both groups across specific visual tasks to measure contrast sensitivity and visual fatigue. Outcomes are evaluated using validated tools, including the Computer Vision Syndrome Questionnaire (CVS-Q) and Visual Fatigue Questionnaire (VFQ), with measurements taken at baseline, 2 weeks, and 4 weeks. Findings are expected to clarify the potential advantages of blue light-blocking glasses over standard lenses, aiding in evidence-based recommendations for adults with varying visual needs.
- Conditions
- Myopia
- Being tested
- Blue Light-Blocking Glasses (Intervention Group), Standard Lenses (Control Group)
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue Light-Blocking Glasses (Intervention Group)Combination product
Participants in this arm wore blue light-blocking glasses designed to filter out a portion of short-wavelength blue light. These lenses were intended to reduce eye strain and protect against blue light exposure, especially during prolonged screen time. Participants used blue light-blocking glasses consistently throughout the study period to assess their effect on contrast sensitivity and visual fatigue.
Standard Lenses (Control Group)Diagnostic test
Participants in this arm wore standard lenses without any blue light-blocking properties. These lenses allow the full spectrum of visible light to pass through and serve as a baseline control to measure against the blue light-blocking glasses. Participants used these lenses under the same conditions to assess contrast sensitivity and visual fatigue without blue light filtration.
| Study group | Role | What they receive |
|---|---|---|
| interventional group | Experimental | Not described Receives: Combination Product: Blue Light-Blocking Glasses (Intervention Group) |
| Control Group | Active comparator | Not described Receives: Diagnostic Test: Standard Lenses (Control Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast Sensitivity
Measured using the Pelli-Robson chart to assess changes in visual acuity and sensitivity to contrast under different lens conditions.
Measured: 12 Months
Visual Fatigue
The Visual Fatigue Questionnaire (VFQ) was assessed to evaluate subjective experiences of eye strain and fatigue during visual tasks.
Computer Vision Syndrome: Evaluated with the Computer Vision Syndrome Questionnaire (CVS-Q) to quantify symptoms associated with prolonged screen use, including dryness, discomfort, and eye strain."
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start28 Feb 2024
- Primary completion1 Aug 2024
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739525
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/749
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Blue of Blue Light-blocking Glasses Versus Standard Lenses on Contrast Sensitivity & Visual Fatigue in Myopic & Non-Myopic Adults
- ClinicalTrials.gov ID
- NCT06739525
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/749
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 18 Dec 2024 (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.
This study investigates the effects of blue light-blocking glasses compared to standard lenses on contrast sensitivity and visual fatigue in myopic and non-myopic adults. With the growing use of digital screens, blue light exposure has raised concerns due to potential eye strain, sleep disruption, and visual fatigue.
Detailed description
While blue light-blocking lenses are marketed to address these issues, evidence of their efficacy, particularly for different refractive errors like myopia, remains inconclusive. Using a randomized controlled design, this study will assess both groups across specific visual tasks to measure contrast sensitivity and visual fatigue. Outcomes are evaluated using validated tools, including the Computer Vision Syndrome Questionnaire (CVS-Q) and Visual Fatigue Questionnaire (VFQ), with measurements taken at baseline, 2 weeks, and 4 weeks. Findings are expected to clarify the potential advantages of blue light-blocking glasses over standard lenses, aiding in evidence-based recommendations for adults with varying visual needs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional group | Experimental | Combination Product: Blue Light-Blocking Glasses (Intervention Group) |
| Control Group | Active comparator | Diagnostic Test: Standard Lenses (Control Group) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 18-50 years.
- Both myopic (with any degree of myopia) and non-myopic adults.
- Participants who use computer screens for at least four hours per day.
- Individuals currently using corrective lenses or willing to wear study-provided glasses during the experiment.
- Individuals willing to complete the study protocol, which includes attending follow-up examinations and filling out visual fatigue questionnaires.
Key exclusion criteria (7 listed)
- A history of any serious vision-related condition (such as glaucoma, cataracts, or retinal problems).
- Individuals who have already undergone refractive surgery (e.g., LASIK) or other types of eye surgery.
- Systemic conditions affecting vision include diabetes, neurological problems, and any other ailment that may impair visual ability.
- Taking drugs that are known to impair vision or produce visual tiredness (for example, certain antihistamines and antidepressants).
- Pregnant women's visual performance may be affected by hormonal changes.
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 |
|---|---|---|
| Blue Light-Blocking Glasses (Intervention Group)Participants in this arm wore blue light-blocking glasses designed to filter out a portion of short-wavelength blue light. These lenses were intended to reduce eye strain and protect against blue light exposure, especially during prolonged screen time. Participants used blue light-blocking glasses consistently throughout the study period to assess their effect on contrast sensitivity and visual fatigue. | Combination product | interventional group |
| Standard Lenses (Control Group)Participants in this arm wore standard lenses without any blue light-blocking properties. These lenses allow the full spectrum of visible light to pass through and serve as a baseline control to measure against the blue light-blocking glasses. Participants used these lenses under the same conditions to assess contrast sensitivity and visual fatigue without blue light filtration. | Diagnostic test | Control Group |
Primary outcome
Contrast Sensitivity
Time frame: 12 Months
Measured using the Pelli-Robson chart to assess changes in visual acuity and sensitivity to contrast under different lens conditions.
Visual Fatigue
Time frame: 12 months
The Visual Fatigue Questionnaire (VFQ) was assessed to evaluate subjective experiences of eye strain and fatigue during visual tasks. Computer Vision Syndrome: Evaluated with the Computer Vision Syndrome Questionnaire (CVS-Q) to quantify symptoms associated with prolonged screen use, including dryness, discomfort, and eye strain."
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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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 Blue Light-Blocking Glasses (Intervention Group) in people with Myopia, run by Superior University at 1 site in Pakistan.
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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2024. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Contrast Sensitivity (time frame: 12 Months). 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 18 Dec 2024.