Clinical trial NCT06394102: Visual Health Evaluation of Natural Color Display Technology
Official title: Visual Health Evaluation of Natural Color Display Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chromatic Adaptation
Keywords: Chromatic adaptation
Reading efficiency
Visual function
Visual fatigue
Fundus blood flow
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Visual fatigue
timeFrame: 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:
measure: Measurement of Accommodative Sensitivity with Flip-Chart Post-VEP Tasks
timeFrame: Each participant will have three measurements: a baseline, and two post-VEP tasks, with immediate flip-chart tests after each task.
measure: AC/A Ratio Measurement Post-VEP Tasks
timeFrame: Each participant will undergo three AC/A ratio measurements: at baseline and immediately after each of two VEP tasks.
measure: Ocular Fundus Blood Flow
timeFrame: 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.
measure: Blink Frequency
timeFrame: Blink frequency 3 minutes after the start of each visual evoked task and 3 minutes before the end
measure: Reading efficiency
timeFrame: The test was recorded 10 minutes after the start and 10 minutes before the end.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospitol,Capital Medical University
state: Beijing
Study officials:
References: