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Visual and Neural Responses to Naked-Eye 3-D Viewing

27 settembre 2026 aggiornato da: Jinyuan,MD, Beijing Tongren Hospital

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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

150

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Beijing, Cina
        • 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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 40 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Simulator Sickness Questionnaire (SSQ) Score
Lasso di tempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in accommodative response (Diopters)
Lasso di tempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing

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
Change in distance phoria (prism diopters)
Lasso di tempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing

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
Change in near phoria (prism diopters)
Lasso di tempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing

Evaluate alteration of near binocular alignment before and after stereoscopic visual exposure.

baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
Change in accommodative convergence/accommodation (AC/A) ratio
Lasso di tempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing

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
Change in non-invasive tear break-up time (seconds)
Lasso di tempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing

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
Change in best-corrected visual acuity (LogMAR)
Lasso di tempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing

Assess transient fluctuation of corrected visual acuity after naked-eye 3D exposure.

baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
Change in intraocular pressure (mmHg)
Lasso di tempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing

Measure pre-post intraocular pressure variation following stereoscopic viewing.

baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
Change in near stereoacuity
Lasso di tempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing

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
Spectral amplitude of theta, alpha, beta and gamma EEG frequency bands
Lasso di tempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing

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
Change in gamma-band resting-state functional connectivity strength
Lasso di tempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing

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
P300 event-related potential peak amplitude (standard stimulus)
Lasso di tempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing

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
P300 event-related potential peak latency (standard stimulus)
Lasso di tempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing

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
P300 peak amplitude and latency under deviant visual stimulus
Lasso di tempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing

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
Change in PANAS positive and negative affect scores
Lasso di tempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing

Evaluate fluctuation of positive and negative emotional states after stereoscopic visual exposure.

baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
Change in state anxiety scale (SAS) total score
Lasso di tempo: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing

Detect transient anxiety level variation before and after naked-eye 3D viewing.

baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Diagnostic performance of multimodal visual fatigue risk prediction model
Lasso di tempo: through study completion, an average of 1 year

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 dicembre 2024

Completamento primario (Effettivo)

20 settembre 2026

Completamento dello studio (Effettivo)

20 settembre 2026

Date di iscrizione allo studio

Primo inviato

9 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 settembre 2026

Primo Inserito (Effettivo)

30 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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