Evaluating the Effectiveness of Comfort Reading Mode in Preventing Dry Eyes and Visual Fatigue

NCT07032909 | Completed

• 1 other identifier: TREC2025-KY099
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to investigate the effects of visual fatigue and dry eye level under different reading background polarities and different text colours, and to evaluate the effect of comfortable reading mode on the improvement of visual fatigue and dry eye level

Conditions

Visual Fatigue

Keywords

electronic display; visual fatigue; tear break-up time; visual function; critical 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 five randomized experimental conditions through study completion, an average of 2 months. For each condition, CFF test was administered at baseline (pre-experiment) and post-task,totaling ten completions per participant.

Secondary Outcomes (4)

• Visual fatigue

  Participants underwent five randomized experimental conditions through study completion, an average of 2 months. For each condition, visual fatigue test was administered at baseline and post-task,totaling ten completions per participant.

• Break up time

  Participants underwent five randomized experimental conditions through study completion, an average of 2 months. For each condition, BUT test was administered at baseline and post-task,totaling ten completions per participant.

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

  Participants underwent five randomized experimental conditions through study completion, an average of 2 months. For each condition, AC/A test was administered at baseline and post-task,totaling ten completions per participant.

• equivalent refraction

  Participants underwent five randomized experimental conditions through study completion, an average of 2 months. For each condition, SE test was administered at baseline and post-task,totaling ten completions per participant.

Study Arms (5)

yellow background and black text mode 1 Group

EXPERIMENTAL

This is the group that performs visual evoked tasks using yellow background and black text mode 1. In this group, the impact of the same text content on the visual fatigue, and tear break-up time were assessed, including but not limited to indicators such as reading efficiency, blinking detection, visual function and retinal fundus blood flow.

Behavioral: comfortable reading mode

yellow background and black text mode 2 Group

EXPERIMENTAL

This is the group that performs visual evoked tasks using yellow background and black text mode 2. In this group, the impact of the same text content on the visual fatigue, and tear break-up time were assessed, including but not limited to indicators such as reading efficiency, blinking detection, visual function and retinal fundus blood flow.

Behavioral: comfortable reading mode

black background and white text mode Group

EXPERIMENTAL

This is the group that performs visual evoked tasks using black background and white text mode. In this group, the impact of the same text content on the visual fatigue, and tear break-up time were assessed, including but not limited to indicators such as reading efficiency, blinking detection, visual function and retinal fundus blood flow.

Behavioral: comfortable reading mode

black background and yellow text mode Group

EXPERIMENTAL

This is the group that performs visual evoked tasks using black background and yellow text mode. In this group, the impact of the same text content on the visual fatigue, and tear break-up time were assessed, including but not limited to indicators such as reading efficiency, blinking detection, visual function and retinal fundus blood flow.

Behavioral: comfortable reading mode

white background and black text mode Group

NO INTERVENTION

This is the group that performs visual evoked tasks using white background and black text mode. In this group, the impact of the same text content on the visual fatigue, and tear break-up time were assessed, including but not limited to indicators such as reading efficiency, blinking detection, visual function and retinal fundus blood flow.

Interventions

comfortable reading mode BEHAVIORAL

Subjects are asked to read a terminal display device for 45 minutes, featuring texts with different reading mode treatments. Specifically, they will read the same text content for 45 minutes with different background and text color. The participants will complete a total of 4 sets of tests in a random order.

black background and white text mode Group; black background and yellow text mode Group; yellow background and black text mode 1 Group; yellow background and black text mode 2 Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult population, regardless of gender.
• Refractive error is less than or equal to -2.5D 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.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospitol,Capital Medical University,

Beijing, Beijing/China, 100730, China

Location

MeSH Terms

Conditions

Asthenopia

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: In order to eliminate the influence of subjective factors during the examination, this study was blinded only to the examiner.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is designed with a total of five groups, where participants will sequentially and randomly undergo all the intervention procedures.

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 24, 2025
• Study Start: June 1, 2025
• Primary Completion: August 15, 2025
• Study Completion: October 30, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)