Clinical trial NCT06984783: Visual Health Evaluation of New Designed Blue-blocking Glasses
Official title: Visual Health Evaluation of New Designed Blue-blocking Glasses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blue-blocking Glasses
Keywords: Blue-blocking Glasses
Visual fatigue
BUT
CFF
Visual function
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study used a within-subject design, where each participant completed both experimental conditions in a randomized order.
Primary purpose: PREVENTION

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.


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.

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.

Primary outcomes:
measure: Critical flicker fusion frequency
timeFrame: 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:
measure: Visual fatigue
timeFrame: 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.
measure: Measurement of Accommodative Sensitivity with Flip-Chart Post-VDT Tasks
timeFrame: 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.
measure: Break up time
timeFrame: 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.
measure: AC/A Ratio Measurement Post-VDT Tasks
timeFrame: 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.
measure: equivalent refraction
timeFrame: 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.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospitol,Capital Medical University
state: Beijing/China
Study officials:
References: