ClinicalTrials.gg
CompletedNCT06984783Updated Dec 30, 2025

Visual Health Evaluation of New Designed Blue-blocking Glasses

An interventional study of The new type of filtering glasses can efficiently filter out the high-energy blue and green light within a narrow wavelength band. and The new type of filtering glasses can efficiently filter out the high-energy blue and green light within a narrow wavelength band. in Blue-blocking Glasses, sponsored by Beijing Tongren Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-30.

Sponsored by Beijing Tongren Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Blue-blocking Glasses

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Keywords

  • Blue-blocking Glasses
  • Visual fatigue
  • BUT
  • CFF
  • Visual function
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In context

Asthenopia

67 studies on the registry are indexed under Asthenopia; 10 are open to participants now.

This study's enrollment of 25 is below the median of 56 across 56 interventional studies indexed under Asthenopia.

Browse Asthenopia studies →

Lead sponsor

Beijing Tongren Hospital is the lead sponsor of 164 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 form.

Exclusion criteria

Exclusion Criteria:

  • 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.

    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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    A Group

    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.

    Combination Product: The new type of filtering glasses can efficiently filter out the high-energy blue and green light within a narrow wavelength band.

  • Experimental
    B Group

    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.

    Combination Product: The new type of filtering glasses can efficiently filter out the high-energy blue and green light within a narrow wavelength band.

Interventions

  • Combination productThe new type of filtering glasses can efficiently filter out the high-energy blue and green light within a narrow wavelength band.

    The new type of filtering glasses can efficiently filter out narrow-band high-energy blue and green light.

    Also known as: An efficient narrow-band filtering VDT protective eyewear

  • Combination productThe new type of filtering glasses can efficiently filter out the high-energy blue and green light within a narrow wavelength band.

    The new type of filtering glasses can efficiently filter out narrow-band high-energy blue and green light.

    Also known as: An efficient narrow-band filtering VDT protective eyewear.

06

What researchers measure

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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

    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.

  4. 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.

    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.

  5. 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

    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.

07

Study locations

1 site
  • Beijing Tongren Hospitol,Capital Medical University
    Beijing, Beijing/China 100730, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06984783
Responsible party
Sponsor
First posted
May 22, 2025
Start date
Apr 18, 2025
Primary completion
Jun 20, 2025
Completion
Jul 10, 2025
Last update
Dec 30, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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