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

2026年9月27日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

150

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Beijing、中国
        • 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

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 40年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Simulator Sickness Questionnaire (SSQ) Score
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Change in accommodative response (Diopters)
大体时间: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)
大体时间: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)
大体时间: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
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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)
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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

其他结果措施

结果测量
措施说明
大体时间
Diagnostic performance of multimodal visual fatigue risk prediction model
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年12月20日

初级完成 (实际的)

2026年9月20日

研究完成 (实际的)

2026年9月20日

研究注册日期

首次提交

2026年8月9日

首先提交符合 QC 标准的

2026年9月27日

首次发布 (实际的)

2026年9月30日

研究记录更新

最后更新发布 (实际的)

2026年9月30日

上次提交的符合 QC 标准的更新

2026年9月27日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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