Chromatic AdaptationNCT06394102
Visual Health Evaluation of Natural Color Display Technology
A study testing The automatic color temperature adjustment mode equipped on terminal display devices can reduce the discrepancy between the color temperature of the device and the ambient light. in people with Chromatic Adaptation, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
Study on visual fatigue and visual function under changing ambient light color temperature by natural color mode: The influence of electronic display devices on visual fatigue of human eyes is the main evaluation index and the main outcome index of this experiment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chromatic Adaptation
- What is being tested?
- The automatic color temperature adjustment mode equipped on terminal display devices can reduce the discrepancy between the color temperature of the device and the ambient light.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2023to 30 Jan 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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 achieve corrected 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
- 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: Only one eye meets the inclusion criteria.
Show all 10Show fewer
- 7: Active corneal infections such as bacterial, fungal, viral, or other acute or chronic anterior segment inflammations.
- 8: Currently using medications that may lead to dry eye or affect vision and corneal curvature.
- 9: Other ocular conditions, such as dacryocystitis, eyelid disorders and abnormalities, abnormal intraocular pressure, and glaucoma.
- 10: 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 Municipality, 100730
About this study
Study on visual fatigue and visual function under changing ambient light color temperature by natural color mode: The influence of electronic display devices on visual fatigue of human eyes is the main evaluation index and the main outcome index of this experiment. Secondary outcome indicators were visual function indicators such as regulation and aggregation. There are other outcome measures: effective reading efficiency, blink detection, retinal fundus blood flow. The baseline values of the above indicators were respectively measured, and then the specific values of different indicators when the natural color mode was enabled and not enabled were collected under the changing ambient light color temperature, and the baseline values were statistically compared and analyzed. Evaluate the effect of natural color patterns on the relief of visual fatigue and on visual function.
- Conditions
- Chromatic Adaptation
- Being tested
- The automatic color temperature adjustment mode equipped on terminal display devices can reduce the discrepancy between the color temperature of the device and the ambient light.
- Keywords
- Chromatic adaptation, Reading efficiency, Visual function, Visual fatigue, Fundus blood flow
- Medical subject headings
- Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The automatic color temperature adjustment mode equipped on terminal display devices can reduce the discrepancy between the color temperature of the device and the ambient light.Other
Also called Automatic color temperature adjustment mode equipped on terminal display devices.
A program mode on a terminal display device that reduces the difference between the color temperature of the ambient light and that of the display device.
| Study group | Role | What they receive |
|---|---|---|
| A Group | Experimental | Is a group that accepts natural color mode processing and then accepts natural color mode closing. In this group, subjects will first be exposed to an environment using a natural color pattern, which applies a specific light source to adjust the color temperature of the ambient light, and the phone color temperature will change with the ambient light color temperature. To evaluate the effects of natural color patterns on visual fatigue and visual function, including but not limited to measures of adjustment function, assembly function, reading efficiency, blink detection, and retinal fundus blood flow. Receives: Other: The automatic color temperature adjustment mode equipped on terminal display devices can reduce the discrepancy between the color temperature of the device and the ambient light. |
| B Group | Experimental | Is the group that accepts the natural color mode off first, and then accepts the natural color mode on. In group B, the subjects will first be in the condition of changing ambient light, and the color temperature of the phone will not change with the ambient light color temperature. Then the experiment was performed on different days to open the natural color mode. The aim is to provide a benchmark against which to compare the effects of natural color pattern treatment in the experimental group. Receives: Other: The automatic color temperature adjustment mode equipped on terminal display devices can reduce the discrepancy between the color temperature of the device and the ambient light. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Each participant will complete the visual fatigue questionnaire, followed immediately by a VEP task, and then re-assess visual fatigue immediately afterward. This sequence will occur twice per group, totaling four assessments per participant.
Secondary outcomes (5)
Measurement of Accommodative Sensitivity with Flip-Chart Post-VEP Tasks
This clinical study involves the assessment of accommodative sensitivity for both monocular and binocular vision using a flip-chart immediately following each visual evoked potential (VEP) task. The measurement will quantify the number of optotypes correctly identified within one minute, indicative of the subject's accommodative capacity.
Measured: Each participant will have three measurements: a baseline, and two post-VEP tasks, with immediate flip-chart tests after each task.
AC/A Ratio Measurement Post-VEP Tasks
This study involves the measurement of the AC/A ratio, which is a critical parameter in binocular vision assessment, reflecting the relationship between accommodation (focus adjustment) and convergence (ocular alignment). The AC/A ratio will be determined using the prism bar technique, which involve adding lenses to stimulate accommodation and measuring the resulting changes in convergence.
Measured: Each participant will undergo three AC/A ratio measurements: at baseline and immediately after each of two VEP tasks.
Ocular Fundus Blood Flow
The study measured the sub foveal choroidal thickness, superficial vessel complex (SVC) density, and deep vessel complex (DVC) density, analyzing changes in retinal blood flow under the two modes.
Measured: Retinal blood flow measurements should be taken within 3 minutes after the completion of each visual evoked potential (VEP) task. There are two VEP tasks per group, along with a baseline measurement, resulting in a total of three measurements.
Blink Frequency
Use electronic devices to record the number of clicks within 3 minutes and calculate the frequency.
Measured: Blink frequency 3 minutes after the start of each visual evoked task and 3 minutes before the end
Reading efficiency
The number pairs were read in the first and last 10 minutes of the visual evoked task, and the number of number pairs read per minute was counted.
Measured: The test was recorded 10 minutes after the start and 10 minutes before the end.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start30 Oct 2023
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chromatic AdaptationStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 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
- NCT06394102
- Sponsor's protocol ID
- TREC2023-KY120
- Status last verified
- Mar 2024
- First submitted
- 8 Apr 2024
- Last updated
- 17 May 2024
- 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 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Health Evaluation of Natural Color Display Technology
- ClinicalTrials.gov ID
- NCT06394102
- Acronym / sponsor ID
- TREC2023-KY120
- Conditions
- Chromatic Adaptation
- Keywords
- Chromatic adaptation, Reading efficiency, Visual function, Visual fatigue, Fundus blood flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 1 May 2024 (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.
Study on visual fatigue and visual function under changing ambient light color temperature by natural color mode: The influence of electronic display devices on visual fatigue of human eyes is the main evaluation index and the main outcome index of this experiment. Secondary outcome indicators were visual function indicators such as regulation and aggregation. There are other outcome measures: effective reading efficiency, blink detection, retinal fundus blood flow. The baseline values of the above indicators were respectively measured, and then the specific values of different indicators when the natural color mode was enabled and not enabled were collected under the changing ambient light color temperature, and the baseline values were statistically compared and analyzed. Evaluate the effect of natural color patterns on the relief of visual fatigue and on visual function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Group | Experimental | Other: The automatic color temperature adjustment mode equipped on terminal display devices can reduce the discrepancy between the color temperature of the device and the ambient light.Is a group that accepts natural color mode processing and then accepts natural color mode closing. In this group, subjects will first be exposed to an environment using a natural color pattern, which applies a specific light source to adjust the color temperature of the ambient light, and the phone color temperature will change with the ambient light color temperature. To evaluate the effects of natural color patterns on visual fatigue and visual function, including but not limited to measures of adjustment function, assembly function, reading efficiency, blink detection, and retinal fundus blood flow. |
| B Group | Experimental | Other: The automatic color temperature adjustment mode equipped on terminal display devices can reduce the discrepancy between the color temperature of the device and the ambient light.Is the group that accepts the natural color mode off first, and then accepts the natural color mode on. In group B, the subjects will first be in the condition of changing ambient light, and the color temperature of the phone will not change with the ambient light color temperature. Then the experiment was performed on different days to open the natural color mode. The aim is to provide a benchmark against which to compare the effects of natural color pattern treatment in the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult population, regardless of gender
- Refractive error is less than or equal to -2.5D and both eyes achieve corrected 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 (10 listed)
- 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).
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 |
|---|---|---|
| The automatic color temperature adjustment mode equipped on terminal display devices can reduce the discrepancy between the color temperature of the device and the ambient light.Also: Automatic color temperature adjustment mode equipped on terminal display devices.A program mode on a terminal display device that reduces the difference between the color temperature of the ambient light and that of the display device. | Other | A Group, B Group |
Primary outcome
Visual fatigue
Time frame: Each participant will complete the visual fatigue questionnaire, followed immediately by a VEP task, and then re-assess visual fatigue immediately afterward. This sequence will occur twice per group, totaling four assessments per participant.
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.
5 secondary outcomes
Measurement of Accommodative Sensitivity with Flip-Chart Post-VEP Tasks
Time frame: Each participant will have three measurements: a baseline, and two post-VEP tasks, with immediate flip-chart tests after each task.
AC/A Ratio Measurement Post-VEP Tasks
Time frame: Each participant will undergo three AC/A ratio measurements: at baseline and immediately after each of two VEP tasks.
Ocular Fundus Blood Flow
Time frame: Retinal blood flow measurements should be taken within 3 minutes after the completion of each visual evoked potential (VEP) task. There are two VEP tasks per group, along with a baseline measurement, resulting in a total of three measurements.
Blink Frequency
Time frame: Blink frequency 3 minutes after the start of each visual evoked task and 3 minutes before the end
Reading efficiency
Time frame: The test was recorded 10 minutes after the start and 10 minutes before the end.
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 17 May 2024.
- Individual participant dataSharing planned: No
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 The automatic color temperature adjustment mode equipped on terminal display devices can reduce the discrepancy between the color temperature of the device and the ambient light. in people with Chromatic Adaptation, 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 10 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 17 May 2024. 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?
Visual fatigue (time frame: Each participant will complete the visual fatigue questionnaire, followed immediately by a VEP task, and then re-assess visual fatigue immediately afterward. This sequence will occur twice per group, totaling four assessments 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 17 May 2024.