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

September 27, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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.
Other: Device / Behavioral Exposure

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Simulator Sickness Questionnaire (SSQ) Score
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in accommodative response (Diopters)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diagnostic performance of multimodal visual fatigue risk prediction model
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tongren Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024KYPJ139

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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