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.

Study Overview

• Status: Completed
• Conditions: Chromatic Adaptation
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Beijing Tongren Hospitol,Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Adult population, regardless of gender
2. Refractive error is less than or equal to -2.5D and both eyes achieve corrected visual acuity of 0.8 or higher.
3. Normal intraocular pressure with no organic pathology.
4. No apparent symptoms of dry eye.
5. Willing to cooperate to complete all the tests.
6. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A Group; 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.	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.; 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.
Experimental: B Group; 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.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	The test was recorded 10 minutes after the start and 10 minutes before the end.

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2023
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 27, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Visual function; Chromatic adaptation; Reading efficiency; Visual fatigue; Fundus blood flow
• Other Study ID Numbers: TREC2023-KY120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No