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

December 27, 2025 updated by: Beijing Tongren Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Critical flicker fusion frequency
Time Frame: 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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual fatigue
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tongren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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