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CompletedNCT07201493Updated Jun 12, 2026

Evaluation of New Color Temperature Adjustment Mode in Preventing Dry Eye and Visual Fatigue

An interventional study of color temperature change mode in Visual Fatigue and Dry Eye, sponsored by Beijing Tongren Hospital. Completed at 1 site in China. Open to participants aged 20 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-12.

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

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 30 Years
Sex
All
01

Study summary

The purpose of this study was to investigate the effects of visual fatigue and dry eye level under different correlated color temperature modes, and to evaluate the effect of new designed dynamic color temperature change modes on the improvement of visual fatigue and dry eye level.

Read the detailed description

The effect of electronic display devices on visual fatigue of human eyes was the primary evaluation index and the primary outcome index of this experiment. Secondary outcome indicators were tear film break-up time, tear lipid analysis, conjunctival congestion score and subjective visual fatigue score. Other outcome indicators were eyeblink detection, accommodative function and Schirmer test. Baseline values of the above metrics were measured separately before each group of trials and then, after 50 minutes of e-text reading, specific values of the different metrics were collected when using different color temperature modes and all valid measurements were statistically compared and analysed. To assess the effect of new designed dynamic color temperature change modes on reducing visual fatigue and dry eye symptoms.

02

Conditions studied

  • Visual Fatigue
  • Dry Eye

Keywords

  • visual fatigue
  • tear break-up time
  • dry eye
  • VDT syndrome
  • critical flicker fusion frequency
03

Who can participate

Ages eligible
20 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adult population, regardless of gender.

    • Refractive error is less than or equal to -1.5D and both eyes achievecorrected visual acuity of 0.8 or higher.
    • Normal intraocular pressure with no organic pathology.
    • No apparent symptoms of dry eye.
    • Willing to cooperate to complete all the tests.
    • Voluntarily signing the informed consent form.

Exclusion criteria

Exclusion Criteria:

  • Individuals with strabismus and amblyopia exist.

    • Suffering from congenital eye conditions such as congenital cataracts or congenital retinal diseases.
    • Those who have undergone intraocular surgery (such as cataract removal, intraocular lens implantation, etc.).
    • Individuals with refractive media opacity (such as corneal lesions, lens opacity, etc.).
    • Only one eye meets the inclusion criteria.
    • Active corneal infections such as bacterial, fungal, viral, or other acute or chronic anterior segment inflammations.
    • Currently using medications that may lead to dry eye or affect vision and corneal curvature.
    • Other ocular conditions, such as dacryocystitis, eyelid disorders and abnormalities, abnormal intraocular pressure, and glaucoma.
    • Unable to undergo regular eye examinations.
04

Study design

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

Study arms

  • No intervention
    6500K group

    This is the group that performs visual evoked tasks using conventional color temperature mode of whose vaule is 6500K. In this group, the impact of the same text content on the visual fatigue and comphrehensive analysis of tear film were assessed, including but not limited to indicators such as blinking detection, visual function and so on.

  • Experimental
    sigmoid change group

    This is the group that performs visual evoked tasks using dynamic color temperature change mode 1 which changes from 6500K to 4000K. In this group, the impact of the same text content on the visual fatigue and comphrehensive analysis of tear film were assessed, including but not limited to indicators such as blinking detection, visual function and so on.

    Behavioral: color temperature change mode

  • Experimental
    gradient change group

    This is the group that performs visual evoked tasks using dynamic color temperature change mode 2 which changes from 6500K to 4000K. In this group, the impact of the same text content on the visual fatigue and comphrehensive analysis of tear film were assessed, including but not limited to indicators such as blinking detection, visual function and so on.

    Behavioral: color temperature change mode

Interventions

  • Behavioralcolor temperature change mode

    Subjects are asked to read a terminal display device for 50 minutes, featuring texts with different color temperature mode treatments. Specifically, they will read the same text content for 50 minutes with different color temperature mode. The participants will complete a total of 2 sets of tests in a random order.

05

What researchers measure

Primary outcomes

  1. Critical flicker fusion frequency

    Critical flicker fusion frequency 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 three randomized experimental conditions through study completion, an average of 1 months. For each condition, CFF test was administered at baseline (pre-experiment) and post-task,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 16 items. It is designed to comprehensively assess the severity of visual fatigue symptoms, with a scoring system ranging from 0 to 4. 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 three randomized experimental conditions through study completion, an average of 1 months. For each condition, visual fatigue test was administered at baseline and post-task,totaling six completions per participant.

  2. tear break-up time

    This clinical study included tear film breakup time measurement using keratograph-7000,OCULUS immediately after each VDT task, reflecting tear film stability, and evaluating the degree of dry eye

    Time frame: Participants underwent three randomized experimental conditions through study completion, an average of 1 months. For each condition, CFF test was administered at baseline (pre-experiment) and post-task,totaling six completions per participant.

  3. 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 three randomized experimental conditions through study completion, an average of 1 months. For each condition, CFF test was administered at baseline (pre-experiment) and post-task,totaling six completions per participant.

Other outcomes

  1. 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 three randomized experimental conditions through study completion, an average of 1 months. For each condition, CFF test was administered at baseline (pre-experiment) and post-task,totaling six completions per participant.

06

Study locations

1 site
  • Beijing Tongren Hospitol,Capital Medical University,, Beijing, Beijing/China
    Beijing, Beijing Municipality 100730, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07201493
Lead sponsor
Beijing Tongren Hospital
Responsible party
Sponsor
First posted
Oct 1, 2025
Start date
Sep 15, 2025
Primary completion
Nov 30, 2025
Completion
Dec 30, 2025
Last update
Jun 12, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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