Blue-blocking GlassesNCT06984783
Visual Health Evaluation of New Designed Blue-blocking Glasses
A study testing The new type of filtering glasses can efficiently filter out the high-energy blue and green light within a narrow wavelength band. in people with Blue-blocking Glasses, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
With the widespread use of electronic display devices, the potential hazards of blue light have become an important public health issue. The primary assessment and main outcome indicators of this experiment are the evaluation of the protective effects of a new type of filtering glasses on visual fatigue in the human… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blue-blocking Glasses
- What is being tested?
- The new type of filtering glasses can efficiently filter out the high-energy blue and green light within a narrow wavelength band.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2025to 10 Jul 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Adult population, regardless of gender 2. Refractive error is less than or equal to -2.5D and both eyes achieve corrected visual acuity of 0.8 or higher. 3. Normal intraocular pressure with no organic pathology. 4. No apparent symptoms of dry eye. 5. Willing to cooperate to complete all the tests. 6. Voluntarily signing the informed consent form.
Who cannot join
- 1: Individuals with strabismus and amblyopia exist. 2: Suffering from congenital eye conditions such as congenital cataracts or congenital retinal diseases.
- 3: Those who have undergone intraocular surgery (such as cataract removal, intraocular lens implantation, etc.).
- 4: Individuals with refractive media opacity (such as corneal lesions, lens opacity, etc.).
- 5: Abnormal intraocular pressure (IOP) (IOP < 10 mmHg or IOP > 21 mmHg, or a bilateral IOP difference of ≥5 mmHg).
- 6: Abnormal intraocular pressure (IOP) (IOP < 10 mmHg or IOP > 21 mmHg, or a bilateral IOP difference of ≥5 mmHg).
- 7: Only one eye meets the inclusion criteria. 8: Active corneal infections such as bacterial, fungal, viral, or other acute or chronic anterior segment inflammations.
Show all 9Show fewer
- 9: Currently using medications that may lead to dry eye or affect vision and corneal curvature.
- 10: Other ocular conditions, such as dacryocystitis, eyelid disorders and abnormalities, abnormal intraocular pressure, and glaucoma.
- 11: Unable to undergo regular eye examinations.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tongren Hospitol,Capital Medical University
Beijing, Beijing/China, 100730
About this study
With the widespread use of electronic display devices, the potential hazards of blue light have become an important public health issue. The primary assessment and main outcome indicators of this experiment are the evaluation of the protective effects of a new type of filtering glasses on visual fatigue in the human eye. Secondary outcome indicators include tear film break-up time, accommodative facility, and subjective visual fatigue scores. Other outcome measurement indicators include visual function indicators such as accommodation and convergence. Baseline values of the above indicators were measured separately, and then specific numerical values of different indicators were collected after working with VDT devices while wearing the new type of filtering glasses or regular framed glasses. These values were statistically compared and analyzed with the baseline values. The study aims to assess the impact of the new type of filtering glasses on relieving visual fatigue and improving visual function.
- Conditions
- Blue-blocking Glasses
- Being tested
- The new type of filtering glasses can efficiently filter out the high-energy blue and green light within a narrow wavelength band.
- Keywords
- Blue-blocking Glasses, Visual fatigue, BUT, CFF, Visual function
- Medical subject headings
- Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The new type of filtering glasses can efficiently filter out the high-energy blue and green light within a narrow wavelength band.Combination product
Also called An efficient narrow-band filtering VDT protective eyewear
The new type of filtering glasses can efficiently filter out narrow-band high-energy blue and green light.
The new type of filtering glasses can efficiently filter out the high-energy blue and green light within a narrow wavelength band.Combination product
Also called An efficient narrow-band filtering VDT protective eyewear.
The new type of filtering glasses can efficiently filter out narrow-band high-energy blue and green light.
| Study group | Role | What they receive |
|---|---|---|
| A Group | Experimental | Is a group that will first wear the new type of filtering glasses for one week of observation, followed by one week of observation wearing regular framed glasses. In this trial group, participants will initially perform VDT (Visual Display Terminal) work while wearing the new filtering glasses for at least two hours per day. On the first afternoon, after wearing blue-light-blocking glasses for two hours of near work on VDT, participants will undergo data collection for the trial (including critical flicker fusion frequency (CFF), binocular visual function, computerized refraction, and tests related to dry eye syndrome, etc.), followed by a visual fatigue questionnaire survey after completing the tasks. For a continuous period of one week, participants will wear blue-light-blocking glasses for at least two hours of near work on VDT each day, and on the seventh afternoon, they will undergo another round of data collection and complete the visual fatigue questionnaire survey. Receives: Combination Product: The new type of filtering glasses can efficiently filter out the high-energy blue and green light within a narrow wavelength band. |
| B Group | Experimental | Is a trial group that first wears regular framed glasses for one week of observation, followed by one week of observation wearing a new type of filtering glasses. In this trial group, subjects will first engage in VDT (Visual Display Terminal) work wearing regular framed glasses for at least two hours per day. On the afternoon of the first day, after wearing regular framed glasses for two hours of near work with VDT, experimental data will be collected (including CFF, binocular visual function, computerized refraction, and tests related to dry eye syndrome, etc.). After completing the tasks, a visual fatigue questionnaire will be conducted. For a continuous period of one week, subjects will wear blue-light filtering glasses for at least two hours of near work with VDT each day. On the afternoon of the seventh day, experimental data collection and a visual fatigue questionnaire will be conducted again. Receives: Combination Product: The new type of filtering glasses can efficiently filter out the high-energy blue and green light within a narrow wavelength band. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Critical flicker fusion frequency
CFF was measured before and after the task by a flicker fusion frequency detection device to assess changes in the degree of ocular fatigue. To compare the difference in CFF after wearing anti-blue glasses with normal glasses and to evaluate the effect of anti-blue glasses in preventing asthenopia.
Measured: Participants underwent two randomized experimental conditions. For each condition, CFF test was administered at baseline (pre-experiment), post-task on day 1, and post-task on day 7, totaling six completions per participant.
Secondary outcomes (5)
Visual fatigue
The visual fatigue questionnaire utilized in this study consists of a self-report survey with a total of 19 items. It is designed to comprehensively assess the severity of visual fatigue symptoms, with a scoring system ranging from 1 to 7. Higher scores indicate more severe symptoms, encompassing three primary domains: ocular symptoms, visual discomfort, and psychological aspects triggered by visual fatigue.
Measured: Participants underwent two randomized experimental conditions. For each condition, visual fatigue questionnaires were administered at baseline (pre-experiment), post-task on day 1, and post-task on day 7, totaling six completions per participant.
Measurement of Accommodative Sensitivity with Flip-Chart Post-VDT Tasks
This clinical study involves the assessment of accommodative sensitivity for both monocular and binocular vision using a flip-chart immediately following each VDT task. The measurement will quantify the number of optotypes correctly identified within one minute, indicative of the subject's accommodative capacity.
Measured: Participants underwent two randomized experimental conditions. For each condition, flip- chart tests were administered at baseline (pre-experiment), post-task on day 1, and post-task on day 7, totaling six completions per participant.
Break up time
This clinical study included tear film breakup time measurement using fluorescein sodium stained paper immediately after each VDT task, reflecting tear film stability, and evaluating the degree of dry eye
Measured: Participants underwent two randomized experimental conditions. For each condition, BUT tests were administered at baseline (pre-experiment), post-task on day 1, and post-task on day 7, totaling six completions per participant.
AC/A Ratio Measurement Post-VDT Tasks
This study involves the measurement of the AC/A ratio, which is a critical parameter in binocular vision assessment, reflecting the relationship between accommodation (focus adjustment) and convergence (ocular alignment). The AC/ A ratio will be determined using the prism bar technique, which involve adding lenses to stimulate accommodation and measuring the resulting changes in convergence.
Measured: Participants underwent two randomized experimental conditions. For each condition, AC/A ratio test was administered at baseline (pre-experiment), post-task on day 1, and post-task on day 7, totaling six completions per participant.
equivalent refraction
This clinical study included testing subjects for equivalent refraction diopters, which can indirectly reflect changes in the degree of myopia in the eye after the use of VDT at close range
Measured: Participants underwent two randomized experimental conditions. For each condition, SE test was administered at baseline (pre-experiment), post-task on day 1, and post-task on day 7, totaling six completions per participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start18 Apr 2025
- Primary completion20 Jun 2025
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blue-blocking GlassesStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study used a within-subject design, where each participant completed both experimental conditions in a randomized order.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984783
- Sponsor's protocol ID
- TREC2025-KY060
- Status last verified
- Jan 2025
- First submitted
- 27 Apr 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- 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 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Health Evaluation of New Designed Blue-blocking Glasses
- ClinicalTrials.gov ID
- NCT06984783
- Acronym / sponsor ID
- TREC2025-KY060
- Conditions
- Blue-blocking Glasses
- Keywords
- Blue-blocking Glasses, Visual fatigue, BUT, CFF, Visual function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 22 May 2025 (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.
With the widespread use of electronic display devices, the potential hazards of blue light have become an important public health issue. The primary assessment and main outcome indicators of this experiment are the evaluation of the protective effects of a new type of filtering glasses on visual fatigue in the human eye. Secondary outcome indicators include tear film break-up time, accommodative facility, and subjective visual fatigue scores. Other outcome measurement indicators include visual function indicators such as accommodation and convergence. Baseline values of the above indicators were measured separately, and then specific numerical values of different indicators were collected after working with VDT devices while wearing the new type of filtering glasses or regular framed glasses. These values were statistically compared and analyzed with the baseline values. The study aims to assess the impact of the new type of filtering glasses on relieving visual fatigue and improving visual function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This study used a within-subject design, where each participant completed both experimental conditions in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| A Group | Experimental | Combination Product: The new type of filtering glasses can efficiently filter out the high-energy blue and green light within a narrow wavelength band.Is a group that will first wear the new type of filtering glasses for one week of observation, followed by one week of observation wearing regular framed glasses. In this trial group, participants will initially perform VDT (Visual Display Terminal) work while wearing the new filtering glasses for at least two hours per day. On the first afternoon, after wearing blue-light-blocking glasses for two hours of near work on VDT, participants will undergo data collection for the trial (including critical flicker fusion frequency (CFF), binocular visual function, computerized refraction, and tests related to dry eye syndrome, etc.), followed by a visual fatigue questionnaire survey after completing the tasks. For a continuous period of one week, participants will wear blue-light-blocking glasses for at least two hours of near work on VDT each day, and on the seventh afternoon, they will undergo another round of data collection and complete the visual fatigue questionnaire survey. |
| B Group | Experimental | Combination Product: The new type of filtering glasses can efficiently filter out the high-energy blue and green light within a narrow wavelength band.Is a trial group that first wears regular framed glasses for one week of observation, followed by one week of observation wearing a new type of filtering glasses. In this trial group, subjects will first engage in VDT (Visual Display Terminal) work wearing regular framed glasses for at least two hours per day. On the afternoon of the first day, after wearing regular framed glasses for two hours of near work with VDT, experimental data will be collected (including CFF, binocular visual function, computerized refraction, and tests related to dry eye syndrome, etc.). After completing the tasks, a visual fatigue questionnaire will be conducted. For a continuous period of one week, subjects will wear blue-light filtering glasses for at least two hours of near work with VDT each day. On the afternoon of the seventh day, experimental data collection and a visual fatigue questionnaire will be conducted again. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Adult population, regardless of gender 2. Refractive error is less than or equal to -2.5D and both eyes achieve corrected visual acuity of 0.8 or higher. 3. Normal intraocular pressure with no organic pathology. 4. No apparent symptoms of dry eye. 5. Willing to cooperate to complete all the tests. 6. Voluntarily signing the informed consent form.
Key exclusion criteria (9 listed)
- 1: Individuals with strabismus and amblyopia exist. 2: Suffering from congenital eye conditions such as congenital cataracts or congenital retinal diseases.
- 3: Those who have undergone intraocular surgery (such as cataract removal, intraocular lens implantation, etc.).
- 4: Individuals with refractive media opacity (such as corneal lesions, lens opacity, etc.).
- 5: Abnormal intraocular pressure (IOP) (IOP < 10 mmHg or IOP > 21 mmHg, or a bilateral IOP difference of ≥5 mmHg).
- 6: Abnormal intraocular pressure (IOP) (IOP < 10 mmHg or IOP > 21 mmHg, or a bilateral IOP difference of ≥5 mmHg).
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 |
|---|---|---|
| The new type of filtering glasses can efficiently filter out the high-energy blue and green light within a narrow wavelength band.Also: An efficient narrow-band filtering VDT protective eyewearThe new type of filtering glasses can efficiently filter out narrow-band high-energy blue and green light. | Combination product | A Group |
| The new type of filtering glasses can efficiently filter out the high-energy blue and green light within a narrow wavelength band.Also: An efficient narrow-band filtering VDT protective eyewear.The new type of filtering glasses can efficiently filter out narrow-band high-energy blue and green light. | Combination product | B Group |
Primary outcome
Critical flicker fusion frequency
Time frame: Participants underwent two randomized experimental conditions. For each condition, CFF test was administered at baseline (pre-experiment), post-task on day 1, and post-task on day 7, totaling six completions per participant.
CFF was measured before and after the task by a flicker fusion frequency detection device to assess changes in the degree of ocular fatigue. To compare the difference in CFF after wearing anti-blue glasses with normal glasses and to evaluate the effect of anti-blue glasses in preventing asthenopia.
5 secondary outcomes
Visual fatigue
Time frame: Participants underwent two randomized experimental conditions. For each condition, visual fatigue questionnaires were administered at baseline (pre-experiment), post-task on day 1, and post-task on day 7, totaling six completions per participant.
Measurement of Accommodative Sensitivity with Flip-Chart Post-VDT Tasks
Time frame: Participants underwent two randomized experimental conditions. For each condition, flip- chart tests were administered at baseline (pre-experiment), post-task on day 1, and post-task on day 7, totaling six completions per participant.
Break up time
Time frame: Participants underwent two randomized experimental conditions. For each condition, BUT tests were administered at baseline (pre-experiment), post-task on day 1, and post-task on day 7, totaling six completions per participant.
AC/A Ratio Measurement Post-VDT Tasks
Time frame: Participants underwent two randomized experimental conditions. For each condition, AC/A ratio test was administered at baseline (pre-experiment), post-task on day 1, and post-task on day 7, totaling six completions per participant.
equivalent refraction
Time frame: Participants underwent two randomized experimental conditions. For each condition, SE test was administered at baseline (pre-experiment), post-task on day 1, and post-task on day 7, totaling six completions per participant.
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 30 Dec 2025.
- 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 The new type of filtering glasses can efficiently filter out the high-energy blue and green light within a narrow wavelength band. in people with Blue-blocking Glasses, run by Beijing Tongren Hospital at 1 site in China.
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 9 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 30 Dec 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 China. 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?
Critical flicker fusion frequency (time frame: Participants underwent two randomized experimental conditions. For each condition, CFF test was administered at baseline (pre-experiment), post-task on day 1, and post-task on day 7, totaling six completions per participant.). 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 30 Dec 2025.