- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07706231
A Study of Full-Spectrum Screen Lighting for Reducing Screen-Related Eye Fatigue and Dry Eye
A Randomized Controlled Trial of the Effects of Full-Spectrum Screen Bar Lighting on Visual Fatigue and Dry Eye After a Standardized Screen Task
This study will evaluate whether full-spectrum screen bar lighting can reduce eye fatigue and dry eye symptoms after a standardized screen task. Prolonged screen use is common in daily work and study and may cause blurred vision, eye soreness, dryness, headache, and reduced attention. Light environment may be one way to improve visual comfort during screen use, but more controlled clinical evidence is needed.
In this randomized, parallel-group controlled study, 112 healthy adult participants will be assigned to either a full-spectrum screen bar lighting group or a brightness-matched control group without screen bar lighting. Participants in both groups will complete an approximately 2-hour standardized screen task in a controlled laboratory environment. The study will compare changes before and after the task in objective and subjective measures of visual fatigue and dry eye, including critical flicker fusion frequency, visual fatigue questionnaire scores, eye movement and blinking parameters, pupil parameters, tear film-related measurements, and dry eye symptom scores. Safety and discomfort during the study will also be recorded.
Přehled studie
Postavení
Detailní popis
Prolonged use of electronic screens is increasingly common in work, study, and daily life and may lead to visual fatigue and dry eye-related symptoms. These symptoms may include blurred vision, eye soreness, dryness, headache, and reduced attention. Although behavioral strategies such as taking breaks and adjusting viewing distance are commonly recommended, their effectiveness may be limited by individual adherence. Optimizing the lighting environment during screen use may provide a standardized and practical approach to improving visual comfort.
This is a single-center, randomized, parallel-group controlled study designed to evaluate the effects of full-spectrum screen bar lighting during a standardized screen task. Eligible healthy adult participants with regular daily screen exposure will be randomly assigned in a 1:1 ratio to either a full-spectrum screen bar lighting group or a brightness-matched control group without screen bar lighting. Both groups will complete the same approximately 2-hour standardized screen task in a controlled laboratory environment. The task may include computer-based text processing, screen reading, or viewing specified video materials, with the task content, duration, and completion requirements kept consistent between groups.
Assessments will be performed before and immediately after the standardized screen task. The study will evaluate changes in objective and subjective measures of visual fatigue, ocular behavioral parameters, and dry eye-related indicators. These include critical flicker fusion frequency, visual fatigue questionnaire scores, eye movement, blinking and pupil parameters, tear film-related measurements, conjunctival redness, and dry eye symptom scores. Safety will be assessed by recording any discomfort or adverse events, such as glare discomfort, eye dryness, tearing, conjunctival redness, headache, nausea, or dizziness.
This study is expected to provide clinical evidence on whether full-spectrum screen bar lighting can help reduce screen-related visual fatigue and dry eye symptoms, and may support the development of lighting strategies for visual health in daily screen-use environments.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Guangdong
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Guangzhou, Guangdong, Čína, 510060
- Zhongshan Ophthalmic Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Age 18 to 35 years, male or female.
- Average daily electronic screen exposure of at least 4 hours.
- Near visual acuity at 40 cm of 0.5 or better, and able to complete the study 1. tasks and measurements stably.
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Presence of ocular inflammation or ocular disease.
- History of severe systemic disease, neurological disease, or psychiatric disorder.
- Pregnancy or lactation.
- Use of dry eye or visual fatigue treatments, or contact lens wear, within 1 month before the study.
- History of ocular surgery within the past 6 months.
- Daily use of lenses with blue-light blocking, photochromic, polarized, filtering, or similar optical functions.
- Professional background in ophthalmology or optical products.
- Intake of caffeine or other stimulants within 4 hours before the study.
- Best-corrected visual acuity (BCVA) less than 0.8.
- Anisometropia of 1.00 diopter or greater, or astigmatism of ±2.00 diopters or greater.
- Intraocular pressure (IOP) less than 5 mmHg or greater than 21 mmHg.
- Non-invasive tear breakup time (NIBUT) less than 5 seconds in either eye.
- Ocular Surface Disease Index (OSDI) score of 33 or greater.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Full-Spectrum Screen Bar Lighting
Participants assigned to this arm will complete an approximately 2-hour standardized screen task in a controlled laboratory environment using a full-spectrum screen bar light (MB23001032H-1B) as task lighting.
The screen task may include computer-based text processing, screen reading, or viewing specified video materials.
Task content, duration, and completion requirements will be kept consistent with the control arm.
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The full-spectrum screen bar light will be used as task lighting during an approximately 2-hour standardized screen task in a controlled laboratory environment.
Participants will complete computer-based text processing, screen reading, or viewing of specified video materials to simulate prolonged near-screen use.
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Komparátor placeba: Brightness-Matched Control
Participants assigned to this arm will complete the same approximately 2-hour standardized screen task in the same controlled laboratory environment without using a full-spectrum screen bar light or any additional screen bar lighting.
Screen brightness will be adjusted to match the brightness condition of the full-spectrum screen bar lighting arm.
Task content, duration, and completion requirements will be kept consistent with the experimental arm.
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Participants will complete the standardized screen task without using a screen bar light.
Screen brightness will be adjusted to match the brightness condition of the full-spectrum screen bar lighting arm.
The task type, content, duration, and completion requirements will be the same as those in the experimental arm.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Critical Flicker Fusion Frequency
Časové okno: Baseline and immediately after completion of the approximately 2-hour standardized screen task
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Critical flicker fusion frequency (CFF) will be measured in Hz using the Handy Flicker HF-III device.
The outcome will be calculated as the post-task CFF value minus the baseline CFF value.
This measure will be used as an objective indicator of visual fatigue after the standardized screen task.
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Baseline and immediately after completion of the approximately 2-hour standardized screen task
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Computer Vision Syndrome Questionnaire Score
Časové okno: Baseline and immediately after completion of the approximately 2-hour standardized screen task
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The Computer Vision Syndrome Questionnaire (CVS-Q) will be used to assess subjective visual fatigue symptoms.
The outcome will be calculated as the post-task total score minus the baseline total score.
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Baseline and immediately after completion of the approximately 2-hour standardized screen task
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Change in EyeFatigue Tracker Ocular Behavioral Parameters
Časové okno: Baseline and immediately after completion of the approximately 2-hour standardized screen task
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Ocular behavioral parameters will be recorded using the EyeFatigue Tracker system during a standardized 1-minute reading task.
The assessment will include eye movement, blink, and pupil-related parameters.
Change values will be calculated as post-task values minus baseline values.
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Baseline and immediately after completion of the approximately 2-hour standardized screen task
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Change in Keratograph 5M Ocular Surface Assessment
Časové okno: Baseline and immediately after completion of the approximately 2-hour standardized screen task
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Objective ocular surface and dry eye-related parameters will be measured using the Keratograph 5M system.
The assessment will include non-invasive tear breakup time, tear meniscus height, and conjunctival redness.
Change values will be calculated as post-task values minus baseline values.
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Baseline and immediately after completion of the approximately 2-hour standardized screen task
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Change in Eye Dryness Score on the 0-100 Visual Analog Scale
Časové okno: Baseline and immediately after completion of the approximately 2-hour standardized screen task
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Eye dryness will be assessed using the Eye Dryness Score on a 0-100 visual analog scale.
Participants will indicate the severity of eye dryness by placing a mark on a 100-mm horizontal line, where 0 represents no eye dryness and 100 represents the most severe eye dryness.
Higher scores indicate worse symptoms.
The change score will be calculated as the score immediately after the standardized screen task minus the baseline score.
A positive change indicates worsening of eye dryness, whereas a negative change indicates improvement.
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Baseline and immediately after completion of the approximately 2-hour standardized screen task
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Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- Chen H, Ratanapakorn T, Sukonpatip M, Asawaphureekorn S, Thinkhamrop W, Wang X, Eungpinichpong W. Effects of yoga facial massage on computer vision syndrome and ocular motor function: A randomised controlled trial. Complement Ther Med. 2025 Dec;95:103270. doi: 10.1016/j.ctim.2025.103270. Epub 2025 Oct 22.
- Ide T, Toda I, Miki E, Tsubota K. Effect of Blue Light-Reducing Eye Glasses on Critical Flicker Frequency. Asia Pac J Ophthalmol (Phila). 2015 Mar-Apr;4(2):80-5. doi: 10.1097/APO.0000000000000069.
- Singh S, Downie LE, Anderson AJ. Do Blue-blocking Lenses Reduce Eye Strain From Extended Screen Time? A Double-Masked Randomized Controlled Trial. Am J Ophthalmol. 2021 Jun;226:243-251. doi: 10.1016/j.ajo.2021.02.010. Epub 2021 Feb 12.
- Lin JB, Gerratt BW, Bassi CJ, Apte RS. Short-Wavelength Light-Blocking Eyeglasses Attenuate Symptoms of Eye Fatigue. Invest Ophthalmol Vis Sci. 2017 Jan 1;58(1):442-447. doi: 10.1167/iovs.16-20663.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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