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

NCT06266910 | Unknown DMC

• 1 other identifier: 2023KYPJ320
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Myopia

Keywords

Myopia; Binocular visual function; Brain network; Neurovascular connectivity

Outcome Measures

Primary Outcomes (2)

• Accommodative facility

  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

  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 Outcomes (7)

• Negative and positive fusional vergence

  8 weeks after intervention

• Accommodative response

  8 weeks after intervention

• negative and positive relative accommodation

  8 weeks after intervention

• Near point of convergence

  8 weeks after intervention

• Accommodation amplitude

  8 weeks after intervention

Study Arms (2)

Three-dimensional (3D) viewing group

EXPERIMENTAL

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

Two-dimensional (2D) viewing group

PLACEBO COMPARATOR

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

Interventions

Visual training video 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.

Three-dimensional (3D) viewing group; Two-dimensional (2D) viewing group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 30 years
• Refractive errors:
• spherical: -9.00 to -0.50 diopters (D), cylindrical: -2.50 to -0 D, and binocular difference within 2.0 D
• Monocular best-corrected visual acuity ≥20/20
• Normal stereoacuity
• Participants capable of understanding the purpose of this study and providing informed consent
• Participants capable of cooperating with relevant examinations.

You may not qualify if:

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

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead
• South China University of Technology: collaborator

Study Sites (1)

Zhongshan Opthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (6)

• 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.

  PMID: 25149555 BACKGROUND

• 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.

  PMID: 30627613 BACKGROUND

• 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.

  PMID: 31233909 BACKGROUND

• 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.

  PMID: 32102791 BACKGROUND

• 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.

  PMID: 35113140 BACKGROUND

• 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.

  PMID: 34844916 BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Yehong Zhuo

CONTACT

13352828998; zhuoyh@mail.sysu.edu.cn

Haishun Huang

CONTACT

13229518626; huanghsh9@mail2.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 20, 2024
• Study Start: February 15, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 10, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)