NCT07201493

Brief Summary

The purpose of this study was to investigate the effects of visual fatigue and dry eye level under different correlated color temperature modes, and to evaluate the effect of new designed dynamic color temperature change modes on the improvement of visual fatigue and dry eye level.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 1, 2025

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

1 month

First QC Date

September 20, 2025

Last Update Submit

September 29, 2025

Conditions

Keywords

visual fatiguetear break-up timedry eyeVDT syndromecritical flicker fusion frequency

Outcome Measures

Primary Outcomes (1)

  • Critical flicker fusion frequency

    Critical flicker fusion frequency was measured before and after the task by a flicker fusion frequency detection device to assess changes in the degree of ocular fatigue. To compare the difference in CFF after wearing anti-blue glasses with normal glasses and to evaluate the effect of anti-blue glasses in preventing asthenopia.

    Participants underwent three randomized experimental conditions through study completion, an average of 1 months. For each condition, CFF test was administered at baseline (pre-experiment) and post-task,totaling six completions per participant.

Secondary Outcomes (3)

  • Visual fatigue

    Participants underwent three randomized experimental conditions through study completion, an average of 1 months. For each condition, visual fatigue test was administered at baseline and post-task,totaling six completions per participant.

  • tear break-up time

    Participants underwent three randomized experimental conditions through study completion, an average of 1 months. For each condition, CFF test was administered at baseline (pre-experiment) and post-task,totaling six completions per participant.

  • Measurement of Accommodative Sensitivity with Flip-Chart Post-VDT Tasks

    Participants underwent three randomized experimental conditions through study completion, an average of 1 months. For each condition, CFF test was administered at baseline (pre-experiment) and post-task,totaling six completions per participant.

Other Outcomes (1)

  • equivalent refraction

    Participants underwent three randomized experimental conditions through study completion, an average of 1 months. For each condition, CFF test was administered at baseline (pre-experiment) and post-task,totaling six completions per participant.

Study Arms (3)

6500K group

NO INTERVENTION

This is the group that performs visual evoked tasks using conventional color temperature mode of whose vaule is 6500K. In this group, the impact of the same text content on the visual fatigue and comphrehensive analysis of tear film were assessed, including but not limited to indicators such as blinking detection, visual function and so on.

sigmoid change group

EXPERIMENTAL

This is the group that performs visual evoked tasks using dynamic color temperature change mode 1 which changes from 6500K to 4000K. In this group, the impact of the same text content on the visual fatigue and comphrehensive analysis of tear film were assessed, including but not limited to indicators such as blinking detection, visual function and so on.

Behavioral: color temperature change mode

gradient change group

EXPERIMENTAL

This is the group that performs visual evoked tasks using dynamic color temperature change mode 2 which changes from 6500K to 4000K. In this group, the impact of the same text content on the visual fatigue and comphrehensive analysis of tear film were assessed, including but not limited to indicators such as blinking detection, visual function and so on.

Behavioral: color temperature change mode

Interventions

Subjects are asked to read a terminal display device for 50 minutes, featuring texts with different color temperature mode treatments. Specifically, they will read the same text content for 50 minutes with different color temperature mode. The participants will complete a total of 2 sets of tests in a random order.

gradient change groupsigmoid change group

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult population, regardless of gender.
  • Refractive error is less than or equal to -1.5D and both eyes achievecorrected 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.

You may not qualify if:

  • Individuals with strabismus and amblyopia exist.
  • Suffering from congenital eye conditions such as congenital cataracts or congenital retinal diseases.
  • Those who have undergone intraocular surgery (such as cataract removal, intraocular lens implantation, etc.).
  • Individuals with refractive media opacity (such as corneal lesions, lens opacity, etc.).
  • Active corneal infections such as bacterial, fungal, viral, or other acute or chronic anterior segment inflammations.
  • Currently using medications that may lead to dry eye or affect vision and corneal curvature.
  • Other ocular conditions, such as dacryocystitis, eyelid disorders and abnormalities, abnormal intraocular pressure, and glaucoma.
  • Unable to undergo regular eye examinations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tongren Hospitol,Capital Medical University,, Beijing, Beijing/China

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

AsthenopiaDry Eye Syndromes

Condition Hierarchy (Ancestors)

Eye DiseasesLacrimal Apparatus Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
In order to eliminate the influence of subjective factors during the examination, this study was blinded only to the participant.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: This study is designed with a total of three groups, where participants will sequentially and randomly undergo all the intervention procedures.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2025

First Posted

October 1, 2025

Study Start

September 15, 2025

Primary Completion

October 15, 2025

Study Completion

December 1, 2025

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations