Effects of Autostereoscopic 3D Visual Training on Binocular Vision Function of Myopes

February 18, 2024 updated by: Zhongshan Ophthalmic Center, Sun Yat-sen University

Exploring the Effects of Autostereoscopic 3D Visual Training on Binocular Vision Function of Myopes Based on EEG and fNIRS

This study intends to conduct a relatively comprehensive binocular visual function examination and follow-up on two groups of myopic subjects, one receiving autostereoscopic 3D vision training and the other receiving 2D vision training as a control. The aim is to explore the impact of autostereoscopic 3D vision training on the accommodation and convergence functions of myopes. Additionally, synchronized EEG-fNIRS signals will be collected to investigate whether changes in binocular visual function are accompanied by corresponding alterations in brain function.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The prevalence of myopia is increasing, posing a serious threat to our visual health. East Asia and Southeast Asia are high-prevalence areas for myopia, with over 80% of young people suffering from myopia. China has one of the highest rates of myopia globally. Preventing myopia occurrence and controlling its progression have become urgent public health issues.

Accommodative function may play an important role in the development of myopia. Studies indicate that factors such as hyperopic defocus caused by accommodation lag, prolonged near-plane fixation, and decreased accommodative flexibility may be associated with the occurrence and development of myopia. Convergence function works synergistically with accommodative function, and its impact on myopia is gradually gaining attention. Scientific and effective training methods to improve both accommodation and convergence functions might help slow down the progression of myopia.

Research by Huang et al. suggests that visual training based on autostereoscopic 3D display technology can improve accommodative lag and enhance accommodative flexibility. However, this study only explored the immediate effects of a single training session, and the long-term effects remain unknown. Furthermore, questions about how training induces changes in the convergence function, whether changes in accommodative function coincide with changes in the convergence function, etc., still need further investigation.

Therefore, this study intends to conduct a relatively comprehensive binocular visual function examination and follow-up on two groups of myopic subjects, one receiving autostereoscopic 3D vision training and the other receiving 2D vision training as a control. The aim is to explore the impact of autostereoscopic 3D vision training on the accommodation and convergence functions of myopes. Additionally, synchronized EEG-fNIRS signals will be collected to investigate whether changes in binocular visual function are accompanied by corresponding alterations in brain function.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • 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 Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Zhongshan Opthalmic Center, Sun Yat-sen University
        • Contact:

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  1. Age 18 to 30 years

  2. Refractive errors:

    spherical: -9.00 to -0.50 diopters (D), cylindrical: -2.50 to -0 D, and binocular difference within 2.0 D

  3. Monocular best-corrected visual acuity ≥20/20
  4. Normal stereoacuity
  5. Participants capable of understanding the purpose of this study and providing informed consent
  6. Participants capable of cooperating with relevant examinations.

Exclusion Criteria:

  1. History of ophthalmic disease other than refractive error, such as strabismus, cataracts, glaucoma, retinal or optic nerve diseases
  2. Use of any medications affecting accommodative function or wearing orthokeratology lenses in the past 1 month
  3. History of ocular trauma or surgery
  4. Suffering from systemic or mental illnesses.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Three-dimensional (3D) viewing group
Participants in this group watch a 10-minute training video displayed in 3D mode, twice a day (totaling 20 minutes), five days a week, for four consecutive weeks.
Other: Visual training video
The video, designed according to the principles of pencil pushups, features a dynamic standard "E" and is presented on an autostereoscopic 3D display equipment.
Placebo Comparator: Two-dimensional (2D) viewing group
Participants in this group watched a 10-minute training video displayed in 2D mode, twice a day (totaling 20 minutes), five days a week, for four consecutive weeks.
Other: Visual training video
The video, designed according to the principles of pencil pushups, features a dynamic standard "E" and is presented on an autostereoscopic 3D display equipment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accommodative facility
Time Frame: 8 weeks after intervention
Accommodative facility was tested using a lens flipper (+2.00D/-2.00 D lens combination) at baseline and 1 day, 1 week, 2 weeks, 4 weeks, and 8 weeks after intervention.
8 weeks after intervention
Vergence facility
Time Frame: 8 weeks after intervention
Vergence facility was tested using a lens flipper (3△BI/12△BO lens combination) at baseline and 1 day, 1 week, 2 weeks, 4 weeks, and 8 weeks after intervention.
8 weeks after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative and positive fusional vergence
Time Frame: 8 weeks after intervention
Negative and positive fusional vergence were measured by phoropter at baseline and 1 day, 1 week, 2 weeks, 4 weeks, and 8 weeks after intervention.
8 weeks after intervention
Accommodative response
Time Frame: 8 weeks after intervention
Accommodative response was measured by the FCC method at baseline and 1 day, 1 week, 2 weeks, 4 weeks, and 8 weeks after intervention.
8 weeks after intervention
negative and positive relative accommodation
Time Frame: 8 weeks after intervention
Negative and positive relative accommodation was measured by phoropter at baseline and 1 day, 1 week, 2 weeks, 4 weeks, and 8 weeks after intervention.
8 weeks after intervention
Near point of convergence
Time Frame: 8 weeks after intervention
Near point of convergence was measured using push-up method at baseline and 1 day, 1 week, 2 weeks, 4 weeks, and 8 weeks after intervention.
8 weeks after intervention
Accommodation amplitude
Time Frame: 8 weeks after intervention
Accommodative amplitude was measured by push-up method at baseline and 1 day, 1 week, 2 weeks, 4 weeks, and 8 weeks after intervention.
8 weeks after intervention
Electroencephalogram (EEG) node efficiency
Time Frame: 8 weeks after intervention
Electroencephalogram was performed to track the electrical activity of the brain in real time at baseline and 1 day, 1 week, 2 weeks, 4 weeks, and 8 weeks after intervention. Node efficiency was calculated. Node efficiency is a metric that characterizes the efficiency of a single node in connecting with all other parts of the network. It reflects the centrality and importance of a node within the network.
8 weeks after intervention
Functional near-infrared spectroscopy (fNIRS)
Time Frame: 8 weeks after intervention
Functional near-infrared spectroscopy (fNIRS) was conducted to capture spatial information on cerebral blood flow and oxygenation conditions at baseline, as well as 1 day, 1 week, 2 weeks, 4 weeks, and 8 weeks after the intervention.
8 weeks after intervention

Collaborators and Investigators

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

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Collaborators

South China University of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

February 15, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

October 10, 2024

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 18, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023KYPJ320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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