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

NCT07848763 | Completed

• 1 other identifier: 2024KYPJ139
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (15)

• Change in accommodative response (Diopters)

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

• Change in distance phoria (prism diopters)

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

• Change in near phoria (prism diopters)

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

• Change in accommodative convergence/accommodation (AC/A) ratio

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

• Change in non-invasive tear break-up time (seconds)

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

Other Outcomes (1)

• Diagnostic performance of multimodal visual fatigue risk prediction model

  through study completion, an average of 1 year

Study Arms (1)

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.

Other: Device / Behavioral Exposure

Interventions

Device / Behavioral Exposure OTHER

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.

Naked-Eye 3D Visual Exposure Arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \. Refuses or cannot complete all three sub-experiment sessions and repeated multimodal tests.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead
• Zhongshan Ophthalmic Center, Sun Yat-sen University: collaborator

Study Sites (1)

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, China

Location

MeSH Terms

Conditions

Asthenopia

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Beijing Tongren Hospital, Chief Physician of Ophthalmology Department

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: September 30, 2026
• Study Start: December 20, 2024
• Primary Completion: September 20, 2026
• Study Completion: September 20, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)