Visual FatigueNCT07032909
Evaluating the Effectiveness of Comfort Reading Mode in Preventing Dry Eyes and Visual Fatigue
A study testing comfortable reading mode in people with Visual Fatigue, 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 reading background polarities and different text colours, and to evaluate the effect of comfortable reading mode on the improvement of visual fatigue and dry eye level Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Fatigue
- What is being tested?
- comfortable reading mode
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 30 Oct 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 40 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 -2.5D 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, 100730
About this study
The purpose of this study was to investigate the effects of visual fatigue and dry eye level under different reading background polarities and different text colours, and to evaluate the effect of comfortable reading mode 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 film height, and subjective visual fatigue score. Other outcome indicators were blink detection, ocular axial length measurement, accommodative function and retinal fundus blood flow. Baseline values of the above metrics were measured separately before each group of trials and then, after 45 minutes of e-text reading, specific values of the different metrics were collected when using different reading modes and all valid measurements were statistically compared and analysed. To assess the effect of comfortable reading modes on reducing visual fatigue and dry eye symptoms.
- Conditions
- Visual Fatigue
- Being tested
- comfortable reading mode
- Keywords
- electronic display, visual fatigue, tear break-up time, visual function, critical flicker fusion frequency
- Medical subject headings
- Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comfortable reading modeBehavioural
Subjects are asked to read a terminal display device for 45 minutes, featuring texts with different reading mode treatments. Specifically, they will read the same text content for 45 minutes with different background and text color. The participants will complete a total of 4 sets of tests in a random order.
| Study group | Role | What they receive |
|---|---|---|
| yellow background and black text mode 1 Group | Experimental | This is the group that performs visual evoked tasks using yellow background and black text mode 1. In this group, the impact of the same text content on the visual fatigue, and tear break-up time were assessed, including but not limited to indicators such as reading efficiency, blinking detection, visual function and retinal fundus blood flow. Receives: Behavioral: comfortable reading mode |
| yellow background and black text mode 2 Group | Experimental | This is the group that performs visual evoked tasks using yellow background and black text mode 2. In this group, the impact of the same text content on the visual fatigue, and tear break-up time were assessed, including but not limited to indicators such as reading efficiency, blinking detection, visual function and retinal fundus blood flow. Receives: Behavioral: comfortable reading mode |
| black background and white text mode Group | Experimental | This is the group that performs visual evoked tasks using black background and white text mode. In this group, the impact of the same text content on the visual fatigue, and tear break-up time were assessed, including but not limited to indicators such as reading efficiency, blinking detection, visual function and retinal fundus blood flow. Receives: Behavioral: comfortable reading mode |
| black background and yellow text mode Group | Experimental | This is the group that performs visual evoked tasks using black background and yellow text mode. In this group, the impact of the same text content on the visual fatigue, and tear break-up time were assessed, including but not limited to indicators such as reading efficiency, blinking detection, visual function and retinal fundus blood flow. Receives: Behavioral: comfortable reading mode |
| white background and black text mode Group | No intervention | This is the group that performs visual evoked tasks using white background and black text mode. In this group, the impact of the same text content on the visual fatigue, and tear break-up time were assessed, including but not limited to indicators such as reading efficiency, blinking detection, visual function and retinal fundus blood flow. |
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 five randomized experimental conditions through study completion, an average of 2 months. For each condition, CFF test was administered at baseline (pre-experiment) and post-task,totaling ten completions per participant.
Secondary outcomes (4)
Visual fatigue
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.
Measured: Participants underwent five randomized experimental conditions through study completion, an average of 2 months. For each condition, visual fatigue test was administered at baseline and post-task,totaling ten completions per participant.
Break up time
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
Measured: Participants underwent five randomized experimental conditions through study completion, an average of 2 months. For each condition, BUT test was administered at baseline and post-task,totaling ten 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 five randomized experimental conditions through study completion, an average of 2 months. For each condition, AC/A test was administered at baseline and post-task,totaling ten completions per participant.
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
Measured: Participants underwent five randomized experimental conditions through study completion, an average of 2 months. For each condition, SE test was administered at baseline and post-task,totaling ten 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 posted24 Jun 2025
- Study start1 Jun 2025
- Primary completion15 Aug 2025
- Study completion30 Oct 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 five groups, where participants will sequentially and randomly undergo all the intervention procedures.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 35 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
- NCT07032909
- Sponsor's protocol ID
- TREC2025-KY099
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 2 Jan 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 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Comfort Reading Mode in Preventing Dry Eyes and Visual Fatigue
- ClinicalTrials.gov ID
- NCT07032909
- Acronym / sponsor ID
- TREC2025-KY099
- Conditions
- Visual Fatigue
- Keywords
- electronic display, visual fatigue, tear break-up time, visual function, critical flicker fusion frequency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 24 Jun 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 reading background polarities and different text colours, and to evaluate the effect of comfortable reading mode 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 film height, and subjective visual fatigue score. Other outcome indicators were blink detection, ocular axial length measurement, accommodative function and retinal fundus blood flow. Baseline values of the above metrics were measured separately before each group of trials and then, after 45 minutes of e-text reading, specific values of the different metrics were collected when using different reading modes and all valid measurements were statistically compared and analysed. To assess the effect of comfortable reading modes on reducing visual fatigue and dry eye symptoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 5
- Model description
- This study is designed with a total of five groups, where participants will sequentially and randomly undergo all the intervention procedures.
| Arm | Type | Receives |
|---|---|---|
| yellow background and black text mode 1 Group | Experimental | Behavioral: comfortable reading modeThis is the group that performs visual evoked tasks using yellow background and black text mode 1. In this group, the impact of the same text content on the visual fatigue, and tear break-up time were assessed, including but not limited to indicators such as reading efficiency, blinking detection, visual function and retinal fundus blood flow. |
| yellow background and black text mode 2 Group | Experimental | Behavioral: comfortable reading modeThis is the group that performs visual evoked tasks using yellow background and black text mode 2. In this group, the impact of the same text content on the visual fatigue, and tear break-up time were assessed, including but not limited to indicators such as reading efficiency, blinking detection, visual function and retinal fundus blood flow. |
| black background and white text mode Group | Experimental | Behavioral: comfortable reading modeThis is the group that performs visual evoked tasks using black background and white text mode. In this group, the impact of the same text content on the visual fatigue, and tear break-up time were assessed, including but not limited to indicators such as reading efficiency, blinking detection, visual function and retinal fundus blood flow. |
| black background and yellow text mode Group | Experimental | Behavioral: comfortable reading modeThis is the group that performs visual evoked tasks using black background and yellow text mode. In this group, the impact of the same text content on the visual fatigue, and tear break-up time were assessed, including but not limited to indicators such as reading efficiency, blinking detection, visual function and retinal fundus blood flow. |
| white background and black text mode Group | No intervention | –This is the group that performs visual evoked tasks using white background and black text mode. In this group, the impact of the same text content on the visual fatigue, and tear break-up time were assessed, including but not limited to indicators such as reading efficiency, blinking detection, visual function and retinal fundus blood flow. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult population, regardless of gender.
- Refractive error is less than or equal to -2.5D 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| comfortable reading modeSubjects are asked to read a terminal display device for 45 minutes, featuring texts with different reading mode treatments. Specifically, they will read the same text content for 45 minutes with different background and text color. The participants will complete a total of 4 sets of tests in a random order. | Behavioural | black background and white text mode Group, black background and yellow text mode Group, yellow background and black text mode 1 Group, yellow background and black text mode 2 Group |
Primary outcome
Critical flicker fusion frequency
Time frame: Participants underwent five randomized experimental conditions through study completion, an average of 2 months. For each condition, CFF test was administered at baseline (pre-experiment) and post-task,totaling ten 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.
4 secondary outcomes
Visual fatigue
Time frame: Participants underwent five randomized experimental conditions through study completion, an average of 2 months. For each condition, visual fatigue test was administered at baseline and post-task,totaling ten completions per participant.
Break up time
Time frame: Participants underwent five randomized experimental conditions through study completion, an average of 2 months. For each condition, BUT test was administered at baseline and post-task,totaling ten completions per participant.
Measurement of Accommodative Sensitivity with Flip-Chart Post-VDT Tasks
Time frame: Participants underwent five randomized experimental conditions through study completion, an average of 2 months. For each condition, AC/A test was administered at baseline and post-task,totaling ten completions per participant.
equivalent refraction
Time frame: Participants underwent five randomized experimental conditions through study completion, an average of 2 months. For each condition, SE test was administered at baseline and post-task,totaling ten 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 2 Jan 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 comfortable reading mode in people with Visual Fatigue, 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 2 Jan 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 five randomized experimental conditions through study completion, an average of 2 months. For each condition, CFF test was administered at baseline (pre-experiment) and post-task,totaling ten 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 2 Jan 2026.