Visual FatigueNCT07201493
Evaluation of New Color Temperature Adjustment Mode in Preventing Dry Eye and Visual Fatigue
A study testing color temperature change mode in people with Visual Fatigue and Dry Eye, run by Beijing Tongren Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Fatigue, Dry Eye
- What is being tested?
- color temperature change mode
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tongren Hospitol,Capital Medical University,, Beijing, Beijing/China
Beijing, Beijing Municipality, 100730
About this study
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.
- Conditions
- Visual Fatigue, Dry Eye
- Being tested
- color temperature change mode
- Keywords
- visual fatigue, tear break-up time, dry eye, VDT syndrome, critical flicker fusion frequency
- Medical subject headings
- Asthenopia, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
color temperature change modeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 6500K group | No intervention | 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. |
| sigmoid change group | Experimental | 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. Receives: Behavioral: color temperature change mode |
| gradient change group | Experimental | 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. Receives: Behavioral: color temperature change mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (3)
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.
Measured: 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.
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
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start15 Sep 2025
- Primary completion30 Nov 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual FatigueStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is designed with a total of three groups, where participants will sequentially and randomly undergo all the intervention procedures.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201493
- Sponsor's protocol ID
- TREC2025-KY185
- Status last verified
- Sep 2025
- First submitted
- 20 Sep 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of New Color Temperature Adjustment Mode in Preventing Dry Eye and Visual Fatigue
- ClinicalTrials.gov ID
- NCT07201493
- Acronym / sponsor ID
- TREC2025-KY185
- Conditions
- Visual Fatigue, Dry Eye
- Keywords
- visual fatigue, tear break-up time, dry eye, VDT syndrome, critical flicker fusion frequency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This study is designed with a total of three groups, where participants will sequentially and randomly undergo all the intervention procedures.
| Arm | Type | Receives |
|---|---|---|
| 6500K group | No intervention | –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. |
| sigmoid change group | Experimental | Behavioral: color temperature change modeThis 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. |
| gradient change group | Experimental | Behavioral: color temperature change modeThis 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. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult population, regardless of gender.
Key exclusion criteria (9 listed)
- Individuals with strabismus and amblyopia exist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| color temperature change modeSubjects 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. | Behavioural | gradient change group, sigmoid change group |
Primary outcome
Critical flicker fusion frequency
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.
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.
3 secondary outcomes
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.
tear break-up time
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.
Measurement of Accommodative Sensitivity with Flip-Chart Post-VDT Tasks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing color temperature change mode in people with Visual Fatigue and Dry Eye, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Critical flicker fusion frequency (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.