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

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

Study Overview

• Status: Completed
• Conditions: Visual Fatigue
• Intervention / Treatment: Behavioral: comfortable reading mode

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

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

Description

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.

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.).
• Only one eye meets the inclusion criteria.
• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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.	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	This clinical study included tear film breakup time measurement using fluorescein sodium stained paper immediately after each VDT task, reflecting tear film stability, and evaluating the degree of dry eye	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	This clinical study involves the assessment of accommodative sensitivity for both monocular and binocular vision using a flip-chart immediately following each VDT task. The measurement will quantify the number of optotypes correctly identified within one minute, indicative of the subject's accommodative capacity.	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	This clinical study included testing subjects for equivalent refraction diopters, which can indirectly reflect changes in the degree of myopia in the eye after the use of VDT at close range	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.

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Actual): August 15, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: May 20, 2025
• First Submitted That Met QC Criteria: June 19, 2025
• First Posted (Actual): June 24, 2025

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: visual function; visual fatigue; electronic display; tear break-up time; critical flicker fusion frequency
• Additional Relevant MeSH Terms: Eye Diseases; Asthenopia
• Other Study ID Numbers: TREC2025-KY099

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
• product manufactured in and exported from the U.S.: No