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Completed

NCT Number: NCT06394102

Visual Health Evaluation of Natural Color Display Technology

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tongren Hospitol,Capital Medical University

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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: Only one eye meets the inclusion criteria.

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.

Treatment and study plan

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

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 names: Automatic color temperature adjustment mode equipped on terminal display devices.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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.

  4. Blink Frequency

    Time frame: Blink frequency 3 minutes after the start of each visual evoked task and 3 minutes before the end

    Use electronic devices to record the number of clicks within 3 minutes and calculate the frequency.

  5. Reading efficiency

    Time frame: The test was recorded 10 minutes after the start and 10 minutes before the end.

    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.

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 1, 2024
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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