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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06266910
• Other study ID #: 2023KYPJ320
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: October 10, 2024

Study information

• Verified date: January 2024
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Yehong Zhuo
• Phone: 13352828998
• Email: zhuoyh[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 10, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

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.

Locations

Country	Name	City	State
China	Zhongshan Opthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University	South China University of Technology

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Negative and positive fusional vergence	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
Secondary	Accommodative response	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
Secondary	negative and positive relative accommodation	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
Secondary	Near point of convergence	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
Secondary	Accommodation amplitude	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
Secondary	Electroencephalogram (EEG) node efficiency	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
Secondary	Functional near-infrared spectroscopy (fNIRS)	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