Visual and Neural Responses to Naked-Eye 3-D Viewing
Multimodal Ocular and Neural Responses to Naked-Eye 3-D Display Exposure: A Prospective Self-Controlled Study
This multicenter study examines short-term changes in visual fatigue and eye function after glasses-free three-dimensional (3D) viewing in healthy adults. The study is conducted at Zhongshan Ophthalmic Center in Guangzhou and Beijing Tongren Hospital in Beijing. Participants complete assessments immediately before and after a 30-minute 3D viewing session and serve as their own controls. The main outcome is the change in self-reported visual fatigue score. Other assessments, according to the procedures approved at each site, may include eye and binocular vision tests, symptom questionnaires, and electroencephalography (EEG). Where approved, additional viewing sessions examine different display settings, including binocular disparity and image crosstalk.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Glasses-free 3D displays create a perception of depth without requiring 3D glasses. Viewing these displays may place demands on binocular vision and visual comfort. This study evaluates immediate responses to a standardized viewing session using subjective ratings and clinical measurements.
This is a multicenter, self-controlled study at Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China, and Beijing Tongren Hospital, Capital Medical University, Beijing, China. Eligible adults provide written informed consent before any study procedures. Each participant completes assessments immediately before viewing standardized glasses-free 3D content for 30 minutes and immediately after viewing.
The primary outcome is the within-participant change in current visual fatigue score, rated on a 0-to-3 scale, from before to after the viewing session. Secondary assessments may include tear film stability, accommodation, ocular alignment, other binocular vision measures, subjective symptoms, and EEG measures, as specified in the applicable site-approved protocol. At sites where additional sessions are approved, predefined display settings may be used to examine responses to different levels of binocular disparity or image crosstalk.
Participants may pause or stop viewing if they experience discomfort. Study staff record symptoms and interruptions during the session. Analyses will describe within-participant changes and account for differences between study sites where combined analysis is appropriate.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing, Porcelana
- Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing Key Laboratory of Intelligent Diagnosis Technology and Equipment for Optic Nerve-Related Eye Diseases, National Engineering Research Center for Ophthalmology
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age ranges 18-40 years old at the time of screening.
- Best-corrected visual acuity ≥0.8 in both eyes.
- Normal stereopsis confirmed via clinical stereo test.
- Spherical equivalent refractive error between -6.00 diopters and +3.00 diopters.
- Astigmatism ≤2.00 D and no clinically significant anisometropia.
- No history of ocular surgery, eye disease, neurological disorder, mental illness or cognitive impairment that affects visual performance.
- Able to understand study procedures and finish all ophthalmological and electroencephalogram examinations.
- Voluntarily provides written informed consent before any study-related operation.
Exclusion Criteria:
- Younger than 18 years or older than 40 years.
- Best-corrected visual acuity less than 0.8 in either eye.
- Impaired or abnormal stereoscopic vision.
- Unqualified refractive error, obvious anisometropia.
- History of keratitis, glaucoma, retinal disease and other organic eye diseases.
- Any history of corneal or intraocular surgery.
- Systemic disease, brain disease and psychiatric disease interfering with visual function.
- 1. Refuses or cannot complete all three sub-experiment sessions and repeated multimodal tests.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Naked-Eye 3D Visual Exposure Arm
Participants view standardized glasses-free 3D content for 30 minutes. Visual fatigue and other approved outcomes are assessed immediately before and after viewing. Where specified in the site-approved protocol, participants may complete additional sessions with predefined binocular disparity or image crosstalk settings. |
Participants view standardized content on a glasses-free 3D display for 30 minutes per session. The display, viewing distance, content, and environmental conditions are documented. Additional sessions using predefined binocular disparity or image crosstalk settings are conducted only where included in the approved study procedures. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Simulator Sickness Questionnaire (SSQ) Score
Periodo de tiempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Validated Simulator Sickness Questionnaire (SSQ). A higher score represents stronger perceived visual burden induced by stereoscopic display. The continuous numeric SSQ scores obtained pre- and post-exposure will be compared by means of a paired-samples t-test, provided that the normality assumption is satisfied; otherwise, the non-parametric Wilcoxon signed-rank test will be adopted. |
baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in accommodative response (Diopters)
Periodo de tiempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Paired comparison of accommodative response value before and after stereoscopic exposure to assess accommodation adaptation induced by naked-eye 3D display. |
baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Change in distance phoria (prism diopters)
Periodo de tiempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Quantify pre-post shift of far-distance binocular alignment after naked-eye 3D viewing. |
baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Change in near phoria (prism diopters)
Periodo de tiempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Evaluate alteration of near binocular alignment before and after stereoscopic visual exposure. |
baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Change in accommodative convergence/accommodation (AC/A) ratio
Periodo de tiempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Detect pre-post variation of AC/A ratio reflecting binocular coordination adaptation under 3D stimulation. |
baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Change in non-invasive tear break-up time (seconds)
Periodo de tiempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Compare pre-post tear film stability to evaluate ocular surface burden from prolonged 3D viewing. |
baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Change in best-corrected visual acuity (LogMAR)
Periodo de tiempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Assess transient fluctuation of corrected visual acuity after naked-eye 3D exposure. |
baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Change in intraocular pressure (mmHg)
Periodo de tiempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Measure pre-post intraocular pressure variation following stereoscopic viewing. |
baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Change in near stereoacuity
Periodo de tiempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Detect alteration of depth perception ability before and after naked-eye 3D stimulation. |
baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Spectral amplitude of theta, alpha, beta and gamma EEG frequency bands
Periodo de tiempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Compare pre-post power amplitude of four core brain wave bands to reflect cortical activation changes. |
baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Change in gamma-band resting-state functional connectivity strength
Periodo de tiempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Evaluate alteration of high-frequency neural synchronization across visual cortex induced by stereoscopic viewing. |
baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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P300 event-related potential peak amplitude (standard stimulus)
Periodo de tiempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Pre-post comparison of P300 amplitude under standard visual stimuli to quantify attentional cortical processing. |
baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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P300 event-related potential peak latency (standard stimulus)
Periodo de tiempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Detect shift of P300 response latency before and after naked-eye 3D exposure. |
baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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P300 peak amplitude and latency under deviant visual stimulus
Periodo de tiempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Assess change of cognitive ERP response to oddball deviant stimuli after stereoscopic viewing. |
baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Change in PANAS positive and negative affect scores
Periodo de tiempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Evaluate fluctuation of positive and negative emotional states after stereoscopic visual exposure. |
baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Change in state anxiety scale (SAS) total score
Periodo de tiempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Detect transient anxiety level variation before and after naked-eye 3D viewing. |
baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Diagnostic performance of multimodal visual fatigue risk prediction model
Periodo de tiempo: through study completion, an average of 1 year
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Multivariable logistic regression model combining baseline phoria and theta-band EEG features; evaluate model discrimination via AUC-ROC, overall accuracy, sensitivity and specificity for identifying participants at high risk of severe post-exposure visual fatigue. |
through study completion, an average of 1 year
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2024KYPJ139
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual participant data will not be shared with external researchers under the current study plan. Participant-level ophthalmic, questionnaire, and EEG data are held by the participating institutions and managed in accordance with the approved consent and institutional data governance requirements. Aggregate results may be reported in publications.
Información sobre medicamentos y dispositivos, documentos del estudio
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