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

NCT ID: NCT06266910

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2024-10-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
By employing a single simulation technology for blinding, both the 2D group and the 3D group share identical training equipment and a consistent video background. The only distinction lies in the subtle variation in the configuration of training markers. It is difficult for participants to differentiate their respective groups.

Study Groups

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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.

Group Type EXPERIMENTAL

Visual training video

Intervention Type OTHER

The video, designed according to the principles of pencil pushups, features a dynamic standard "E" and is presented on an autostereoscopic 3D display equipment.

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.

Group Type PLACEBO_COMPARATOR

Visual training video

Intervention Type OTHER

The video, designed according to the principles of pencil pushups, features a dynamic standard "E" and is presented on an autostereoscopic 3D display equipment.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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South China University of Technology

UNKNOWN

Sponsor Role collaborator

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhongshan Opthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Yehong Zhuo

Role: CONTACT

13352828998

Haishun Huang

Role: CONTACT

13229518626

Facility Contacts

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Yehong Zhuo

Role: primary

13352828998

References

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Han J, Hong S, Lee S, Kim JK, Lee HK, Han SH. Changes in fusional vergence amplitudes after laser refractive surgery for moderate myopia. J Cataract Refract Surg. 2014 Oct;40(10):1670-5. doi: 10.1016/j.jcrs.2014.01.043. Epub 2014 Aug 20.

Reference Type BACKGROUND
PMID: 25149555 (View on PubMed)

Tsujimoto K, Mizuno K, Nishida D, Tahara M, Yamada E, Shindo S, Watanabe Y, Kasuga S, Liu M. Correlation between changes in functional connectivity in the dorsal attention network and the after-effects induced by prism adaptation in healthy humans: A dataset of resting-state fMRI and pointing after prism adaptation. Data Brief. 2018 Dec 18;22:583-589. doi: 10.1016/j.dib.2018.12.053. eCollection 2019 Feb.

Reference Type BACKGROUND
PMID: 30627613 (View on PubMed)

Wilf M, Serino A, Clarke S, Crottaz-Herbette S. Prism adaptation enhances decoupling between the default mode network and the attentional networks. Neuroimage. 2019 Oct 15;200:210-220. doi: 10.1016/j.neuroimage.2019.06.050. Epub 2019 Jun 22.

Reference Type BACKGROUND
PMID: 31233909 (View on PubMed)

Ang M, Flanagan JL, Wong CW, Muller A, Davis A, Keys D, Resnikoff S, Jong M, Wong TY, Sankaridurg P. Review: Myopia control strategies recommendations from the 2018 WHO/IAPB/BHVI Meeting on Myopia. Br J Ophthalmol. 2020 Nov;104(11):1482-1487. doi: 10.1136/bjophthalmol-2019-315575. Epub 2020 Feb 26.

Reference Type BACKGROUND
PMID: 32102791 (View on PubMed)

Huang Y, Li M, Shen Y, Liu F, Fang Y, Xu H, Zhou X. Study of the Immediate Effects of Autostereoscopic 3D Visual Training on the Accommodative Functions of Myopes. Invest Ophthalmol Vis Sci. 2022 Feb 1;63(2):9. doi: 10.1167/iovs.63.2.9.

Reference Type BACKGROUND
PMID: 35113140 (View on PubMed)

Zhu Z, Chen Y, Tan Z, Xiong R, McGuinness MB, Muller A. Interventions recommended for myopia prevention and control among children and adolescents in China: a systematic review. Br J Ophthalmol. 2023 Feb;107(2):160-166. doi: 10.1136/bjophthalmol-2021-319306. Epub 2021 Nov 29.

Reference Type BACKGROUND
PMID: 34844916 (View on PubMed)

Other Identifiers

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2023KYPJ320

Identifier Type: -

Identifier Source: org_study_id

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