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Completed

NCT Number: NCT06984783

Visual Health Evaluation of New Designed Blue-blocking Glasses

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.

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Key information

Conditions

Blue-blocking Glasses Asthenopia Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tongren Hospitol,Capital Medical University

Beijing, Beijing/China, 100730, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 informed consent form.

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.

Treatment and study plan

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

Combination Product

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

Other names: An efficient narrow-band filtering VDT protective eyewear

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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

  4. 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.

    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.

  5. 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.

    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

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 22, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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