AsthenopiaNCT07848763
Visual and Neural Responses to Naked-Eye 3-D Viewing
A study testing Device / Behavioral Exposure in people with Asthenopia and Visual Fatigue, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthenopia, Visual Fatigue, Binocular Vision Disorder
- What is being tested?
- Device / Behavioral Exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2024to 20 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
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
Beijing
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthenopia, Visual Fatigue, Binocular Vision Disorder
- Being tested
- Device / Behavioral Exposure
- Keywords
- Naked-Eye 3D Display, Autostereoscopic Display, Glasses-Free Stereoscopic Vision, Binocular Disparity,, Electroencephalography (EEG), Visual Safety Evaluation
- Medical subject headings
- Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device / Behavioral ExposureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Naked-Eye 3D Visual Exposure Arm | Other | 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. Receives: Other: Device / Behavioral Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Simulator Sickness Questionnaire (SSQ) Score
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.
Measured: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
Secondary outcomes (15)
Change in accommodative response (Diopters)
Paired comparison of accommodative response value before and after stereoscopic exposure to assess accommodation adaptation induced by naked-eye 3D display.
Measured: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
Change in distance phoria (prism diopters)
Quantify pre-post shift of far-distance binocular alignment after naked-eye 3D viewing.
Measured: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
Change in near phoria (prism diopters)
Evaluate alteration of near binocular alignment before and after stereoscopic visual exposure.
Measured: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
Change in accommodative convergence/accommodation (AC/A) ratio
Detect pre-post variation of AC/A ratio reflecting binocular coordination adaptation under 3D stimulation.
Measured: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
Change in non-invasive tear break-up time (seconds)
Compare pre-post tear film stability to evaluate ocular surface burden from prolonged 3D viewing.
Measured: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
Change in best-corrected visual acuity (LogMAR)
Assess transient fluctuation of corrected visual acuity after naked-eye 3D exposure.
Measured: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
Change in intraocular pressure (mmHg)
Measure pre-post intraocular pressure variation following stereoscopic viewing.
Measured: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
Change in near stereoacuity
Detect alteration of depth perception ability before and after naked-eye 3D stimulation.
Measured: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
Spectral amplitude of theta, alpha, beta and gamma EEG frequency bands
Compare pre-post power amplitude of four core brain wave bands to reflect cortical activation changes.
Measured: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
Change in gamma-band resting-state functional connectivity strength
Evaluate alteration of high-frequency neural synchronization across visual cortex induced by stereoscopic viewing.
Measured: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
P300 event-related potential peak amplitude (standard stimulus)
Pre-post comparison of P300 amplitude under standard visual stimuli to quantify attentional cortical processing.
Measured: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
P300 event-related potential peak latency (standard stimulus)
Detect shift of P300 response latency before and after naked-eye 3D exposure.
Measured: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
P300 peak amplitude and latency under deviant visual stimulus
Assess change of cognitive ERP response to oddball deviant stimuli after stereoscopic viewing.
Measured: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
Change in PANAS positive and negative affect scores
Evaluate fluctuation of positive and negative emotional states after stereoscopic visual exposure.
Measured: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
Change in state anxiety scale (SAS) total score
Detect transient anxiety level variation before and after naked-eye 3D viewing.
Measured: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start20 Dec 2024
- Primary completion20 Sep 2026
- Study completion20 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthenopiaStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Responsible party
- Principal investigator, Jinyuan,MD, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848763
- Sponsor's protocol ID
- 2024KYPJ139
- Status last verified
- Sep 2026
- First submitted
- 9 Aug 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Ocular and Neural Responses to Naked-Eye 3-D Display Exposure: A Prospective Self-Controlled Study
- ClinicalTrials.gov ID
- NCT07848763
- Acronym / sponsor ID
- 2024KYPJ139
- Conditions
- Asthenopia, Visual Fatigue, Binocular Vision Disorder
- Keywords
- Naked-Eye 3D Display, Autostereoscopic Display, Glasses-Free Stereoscopic Vision, Binocular Disparity,, Electroencephalography (EEG), Visual Safety Evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Collaborators
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 20 Sep 2026 (actual)
- Study completion
- 20 Sep 2026 (actual)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Naked-Eye 3D Visual Exposure Arm | Other | Other: Device / Behavioral ExposureParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device / Behavioral ExposureParticipants 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. | Other | Naked-Eye 3D Visual Exposure Arm |
Primary outcome
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.
15 secondary outcomes
Change in accommodative response (Diopters)
Time frame: 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
Change in near phoria (prism diopters)
Time frame: 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
Change in non-invasive tear break-up time (seconds)
Time frame: 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
Change in intraocular pressure (mmHg)
Time frame: 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
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
Change in gamma-band resting-state functional connectivity strength
Time frame: 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
P300 event-related potential peak latency (standard stimulus)
Time frame: 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
Change in PANAS positive and negative affect scores
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device / Behavioral Exposure in people with Asthenopia and Visual Fatigue, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Simulator Sickness Questionnaire (SSQ) Score (time frame: baseline (pre-exposure), immediately after 30-minute naked-eye 3-D viewing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.