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Completed

NCT Number: NCT07032909

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

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Key information

Conditions

Visual Fatigue Asthenopia Eye Diseases

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tongren Hospitol,Capital Medical University,

Beijing, Beijing/China, 100730, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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