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Clinical Trials/NCT06394102
NCT06394102CompletedNot Applicable

Visual Health Evaluation of Natural Color Display Technology

Beijing Tongren Hospital1 site in 1 country24 target enrollmentStarted: October 30, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
24
Locations
1
Primary Endpoint
Visual fatigue

Study Overview

Brief 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. 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

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.

Intervention: 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)

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.

Intervention: 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)

Outcomes

Primary Outcomes

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

  • Measurement of Accommodative Sensitivity with Flip-Chart Post-VEP Tasks(Each participant will have three measurements: a baseline, and two post-VEP tasks, with immediate flip-chart tests after each task.)
  • Ocular Fundus Blood Flow(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(Blink frequency 3 minutes after the start of each visual evoked task and 3 minutes before the end)
  • Reading efficiency(The test was recorded 10 minutes after the start and 10 minutes before the end.)
  • AC/A Ratio Measurement Post-VEP Tasks(Each participant will undergo three AC/A ratio measurements: at baseline and immediately after each of two VEP tasks.)

Investigators

Sponsor
Beijing Tongren Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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