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

NCT ID: NCT07032909

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2025-10-30

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

Detailed Description

The effect of electronic display devices on visual fatigue of human eyes was the primary evaluation index and the primary outcome index of this experiment. Secondary outcome indicators were tear film break-up time, tear film height, and subjective visual fatigue score. Other outcome indicators were blink detection, ocular axial length measurement, accommodative function and retinal fundus blood flow. Baseline values of the above metrics were measured separately before each group of trials and then, after 45 minutes of e-text reading, specific values of the different metrics were collected when using different reading modes and all valid measurements were statistically compared and analysed. To assess the effect of comfortable reading modes on reducing visual fatigue and dry eye symptoms.

Conditions

Visual Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

yellow background and black text mode 1 Group

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.

Group Type: EXPERIMENTAL

comfortable reading mode

Intervention Type: 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.

yellow background and black text mode 2 Group

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.

Group Type: EXPERIMENTAL

comfortable reading mode

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

comfortable reading mode

Intervention Type: 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 yellow text mode Group

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.

Group Type: EXPERIMENTAL

comfortable reading mode

Intervention Type: 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.

white background and black text mode Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

comfortable reading mode

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

Exclusion Criteria

• 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.).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Tongren Hospitol,Capital Medical University,

Beijing, Beijing/China, China

Countries

China

Other Identifiers

TREC2025-KY099

Identifier Type: -

Identifier Source: org_study_id