MyopiaNCT06266910
Effects of Autostereoscopic 3D Visual Training on Binocular Vision Function of Myopes
A study testing Visual training video in people with Myopia, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Visual training video
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2024to 10 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Opthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Yehong Zhuo, 13352828998, zhuoyh@mail.sysu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Myopia
- Being tested
- Visual training video
- Keywords
- Myopia, Binocular visual function, Brain network, Neurovascular connectivity
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual training videoOther
The video, designed according to the principles of pencil pushups, features a dynamic standard "E" and is presented on an autostereoscopic 3D display equipment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Visual training video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks after intervention
Secondary outcomes (7)
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.
Measured: 8 weeks after intervention
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.
Measured: 8 weeks after intervention
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.
Measured: 8 weeks after intervention
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.
Measured: 8 weeks after intervention
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.
Measured: 8 weeks after intervention
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.
Measured: 8 weeks after intervention
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.
Measured: 8 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Feb 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion10 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- South China University of Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266910
- Sponsor's protocol ID
- 2023KYPJ320
- Status last verified
- Jan 2024
- First submitted
- 1 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25149555Tsujimoto 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.
PubMed 30627613Wilf 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.
PubMed 31233909Ang 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.
PubMed 32102791Huang 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.
PubMed 35113140Zhu 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.
PubMed 34844916
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Autostereoscopic 3D Visual Training on Binocular Vision Function of Myopes Based on EEG and fNIRS
- ClinicalTrials.gov ID
- NCT06266910
- Acronym / sponsor ID
- 2023KYPJ320
- Conditions
- Myopia
- Keywords
- Myopia, Binocular visual function, Brain network, Neurovascular connectivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- South China University of Technology
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 10 Oct 2024 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Three-dimensional (3D) viewing group | Experimental | Other: Visual training videoParticipants 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. |
| Two-dimensional (2D) viewing group | Placebo comparator | Other: Visual training videoParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual training videoThe video, designed according to the principles of pencil pushups, features a dynamic standard "E" and is presented on an autostereoscopic 3D display equipment. | Other | Three-dimensional (3D) viewing group, Two-dimensional (2D) viewing group |
Primary outcome
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.
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.
7 secondary outcomes
Negative and positive fusional vergence
Time frame: 8 weeks after intervention
Accommodative response
Time frame: 8 weeks after intervention
negative and positive relative accommodation
Time frame: 8 weeks after intervention
Near point of convergence
Time frame: 8 weeks after intervention
Accommodation amplitude
Time frame: 8 weeks after intervention
Electroencephalogram (EEG) node efficiency
Time frame: 8 weeks after intervention
Functional near-infrared spectroscopy (fNIRS)
Time frame: 8 weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 25149555Han 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.
- Background: PubMed 30627613Tsujimoto 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.
- Background: PubMed 31233909Wilf 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.
- Background: PubMed 32102791Ang 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.
- Background: PubMed 35113140Huang 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.
- Background: PubMed 34844916Zhu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual training video in people with Myopia, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yehong Zhuo (13352828998, zhuoyh@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accommodative facility (time frame: 8 weeks after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06266910, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.