Visual Health Evaluation of New Designed Blue-blocking Glasses

NCT ID: NCT06984783

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-18
• Study Completion Date: 2025-07-10

Brief 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.

Conditions

Blue-blocking Glasses

Keywords

Blue-blocking Glasses; Visual fatigue; BUT; CFF; Visual function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: COMBINATION_PRODUCT

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: COMBINATION_PRODUCT

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

Interventions

The 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.

Intervention Type: COMBINATION_PRODUCT

The 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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

An efficient narrow-band filtering VDT protective eyewear; An efficient narrow-band filtering VDT protective eyewear.

Eligibility Criteria

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.

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.

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Tongren Hospitol,Capital Medical University

Beijing, Beijing/China, China

Countries

China

Other Identifiers

TREC2025-KY060

Identifier Type: -

Identifier Source: org_study_id