PresbyopiaNCT06853691
The Effects of Glasses-Free 3D Training on Visual and Cognitive Function in Presbyopic Individuals
A study testing glasses-free 3D visual training in people with Presbyopia, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
This study aims to evaluate the effectiveness of glasses-free 3D visual training in improving visual function, visual comfort, and the application ability of visual functions in individuals with presbyopia. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- glasses-free 3D visual training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 40-60 years old, both sexes;
- refractive error -6.0D to 5.0D, astigmatism <2.0D, anisometropia <4.0D;
- binocular corrected visual acuity <0.2LogMAR;
- stereoscopic threshold ≤100 ';
- The subjects could understand the purpose of this study and sign the informed consent.
Who cannot join
- after lens replacement; People with cataracts, which affect vision, have other eye conditions such that simultaneous vision is not possible;
- using any medication known to affect accommodative function or wearing orthokeratology lenses in the past 1 month;
- patients with severe systemic disease or severe mental illness;
- Other situations where the investigator considers that the subject should not participate in the study for safety reasons or the interests of the patient.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Opthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Yehong Zhuo, professor, 020-66619349, zhuoyh@mail.sysu.edu.cn
About this study
This study aims to evaluate the effectiveness of glasses-free 3D visual training in improving visual function, visual comfort, and the application ability of visual functions in individuals with presbyopia. The research will assess changes in brain activity related to visual processing using Electroencephalogram(EEG)and Functional near-infrared spectroscopy(NIRS) before and after the training. By examining the impact of stereoscopic stimulation on the functional connectivity of brain regions, the study seeks to provide new insights into the rehabilitation of presbyopia and its underlying mechanisms. The goal is to offer a non-invasive and scientifically supported approach to improving presbyopia treatment, potentially advancing clinical practices and contributing to brain science and ophthalmology
Read the detailed description
Presbyopia is a manifestation of aging, and the prevalence of presbyopia increases with age. About 1.7 to 2 billion people in the world have presbyopia. According to the criteria proposed by Hofstetter in 1950, presbyopia symptoms begin to appear in different individuals from the age of 40, and complete presbyopia occurs at the age of 60. With the occurrence of presbyopia, there will be a series of accompanying diseases, such as the decrease of contrast sensitivity, leading to visual discomfort. Moreover, near work is difficult and even affects daily life.
Conventional ophthalmic analysis and intervention are sufficient. Although invasive correction methods can achieve satisfactory visual quality, there is a certain surgical risk. It is necessary to consider not only the patient's general condition, but also the follow-up care. Some monocular correction at the cost of binocular stereoscopic vision will cause the damage of depth perception and seriously affect stereoscopic vision. Non-invasive methods also have certain limitations, such as glasses correction will increase the risk of falls due to the surrounding jumping and swimming effects, the effect of drugs is temporary, and will cause a series of adverse reactions. The glasses-free 3D vision training equipment is simple to operate, easy to implement the training process, and the content is variable, and no other equipment is needed. Due to the popularity of video terminals, the prevalence of electronic device related asthenopia is also increasing. In order to explore the improvement of accommodation function and the relief of asthenopia after glasses-free 3D training, a randomized controlled trial was designed. The effects of this training on the central nervous system were analyzed by electroencephalogram (EEG) and near-infrared spectroscopy (fNIRS).
The aim of this study is to evaluate the improvement of visual function, application ability of visual function, and visual comfort in patients with presbyopia through the intervention of glasses-free 3D visual training, and to evaluate the functional changes of brain visual-related areas in patients with presbyopia before and after the training combined with EEG and NIRS. To explore the effects of stereoscopic stimulation on the functional connectivity of brain regions and different frequency bands. To explore the scientific nature and effectiveness of glasses-free 3D visual training in the rehabilitation of presbyopia, to provide a new theoretical basis and method for the clinical treatment of presbyopia, and to provide more information and clues for exploring the complex stereo vision imaging mechanism in the fields of brain science and ophthalmology.
- Conditions
- Presbyopia
- Being tested
- glasses-free 3D visual training
- Keywords
- Presbyopia, visual training, EEG, fNIRS
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glasses-free 3D visual trainingOther
Trail group Conduct 15 minutes of naked-eye 3D vision training. Twice a day, five days a week.
Control groups The subjects watched ordinary 2D videos for 15 minutes each time, all under the same lighting conditions. This was done twice a day, five days a week.
| Study group | Role | What they receive |
|---|---|---|
| Trail group | Experimental | Conduct 15 minutes of naked-eye 3D vision training. Twice a day, five days a week. Receives: Other: glasses-free 3D visual training |
| Control groups | No intervention | The subjects watched ordinary 2D videos for 15 minutes each time, all under the same lighting conditions. This was done twice a day, five days a week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of accommodation
The push-up method combined with negative lens method was used. The measurements were completed by a comprehensive refractometer. It was performed according to the methods in Clinical Procedures for Ocular Examination 4th
Measured: Baseline and after 6 and 12 weeks of training
Secondary outcomes (9)
Asthenopia scale
The asthenopia scale consisted of 2 self-assessment items (" Do you have symptoms of asthenopia "and" does eye fatigue affect your study, work or life ") and 19 symptom items (" Do you feel discomfort around the eyes ")
Measured: Baseline and after 6 and 12 weeks of training
Vergence facility
Vergence facility was tested using a lens flipper (3△BI/12△BO lens combination per eye) at 40cm with near correction
Measured: Baseline and after 6 and 12 weeks of training
Accommodative convergence to accommodation(AC/A)
Accommodative response was measured by WAM-5500. Additional accommodative and vergence stimuli were provided by spherical lenses
Measured: Baseline and after 6 and 12 weeks of training
The node efficiency
Electroencephalogram (EEG) was performed to track the electrical activity of the brain in real-time, and the 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: Baseline and after 6 and 12 weeks of training
Hemodynamic response functions
Functional near-infrared spectroscopy (fNIRS) was conducted to capture spatial information on cerebral blood flow and oxygenation conditions. Therefore, a hemodynamic response function was constructed through it.
Measured: Baseline and after 6 and 12 weeks of training
Convergence accommodation to convergence(CA/C)
Accommodative response was measured by WAM-5500,Additional accommodative and vergence stimuli were provided by prisms
Measured: Baseline and after 6 and 12 weeks of training
Functional connectivity network
Electroencephalogram (EEG) was performed to track the electrical activity of the brain in real-time, and the functional connectivity network was calculated.
Functional connectivity represent changes in brain activity in time domain and frequency domain respectively through correlation and coherence.
Measured: Baseline and after 6 and 12 weeks of training
Negative relative vergence
Negative relative vergence were measured by base in prism at 40cm with near correction
Measured: Baseline and after 6 and 12 weeks of training
Positive relative vergence
Positive relative vergence were measured by base out prism at 40cm with near correction
Measured: Baseline and after 6 and 12 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start27 Feb 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853691
- Sponsor's protocol ID
- 2024KYPJ113
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Glasses-Free 3D Training on Visual and Cognitive Function in Presbyopic Individuals
- ClinicalTrials.gov ID
- NCT06853691
- Acronym / sponsor ID
- 2024KYPJ113
- Conditions
- Presbyopia
- Keywords
- Presbyopia, visual training, EEG, fNIRS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 27 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 3 Mar 2025 (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 aims to evaluate the effectiveness of glasses-free 3D visual training in improving visual function, visual comfort, and the application ability of visual functions in individuals with presbyopia. The research will assess changes in brain activity related to visual processing using Electroencephalogram(EEG)and Functional near-infrared spectroscopy(NIRS) before and after the training. By examining the impact of stereoscopic stimulation on the functional connectivity of brain regions, the study seeks to provide new insights into the rehabilitation of presbyopia and its underlying mechanisms. The goal is to offer a non-invasive and scientifically supported approach to improving presbyopia treatment, potentially advancing clinical practices and contributing to brain science and ophthalmology
Detailed description
Presbyopia is a manifestation of aging, and the prevalence of presbyopia increases with age. About 1.7 to 2 billion people in the world have presbyopia. According to the criteria proposed by Hofstetter in 1950, presbyopia symptoms begin to appear in different individuals from the age of 40, and complete presbyopia occurs at the age of 60. With the occurrence of presbyopia, there will be a series of accompanying diseases, such as the decrease of contrast sensitivity, leading to visual discomfort. Moreover, near work is difficult and even affects daily life.
Conventional ophthalmic analysis and intervention are sufficient. Although invasive correction methods can achieve satisfactory visual quality, there is a certain surgical risk. It is necessary to consider not only the patient's general condition, but also the follow-up care. Some monocular correction at the cost of binocular stereoscopic vision will cause the damage of depth perception and seriously affect stereoscopic vision. Non-invasive methods also have certain limitations, such as glasses correction will increase the risk of falls due to the surrounding jumping and swimming effects, the effect of drugs is temporary, and will cause a series of adverse reactions. The glasses-free 3D vision training equipment is simple to operate, easy to implement the training process, and the content is variable, and no other equipment is needed. Due to the popularity of video terminals, the prevalence of electronic device related asthenopia is also increasing. In order to explore the improvement of accommodation function and the relief of asthenopia after glasses-free 3D training, a randomized controlled trial was designed. The effects of this training on the central nervous system were analyzed by electroencephalogram (EEG) and near-infrared spectroscopy (fNIRS).
The aim of this study is to evaluate the improvement of visual function, application ability of visual function, and visual comfort in patients with presbyopia through the intervention of glasses-free 3D visual training, and to evaluate the functional changes of brain visual-related areas in patients with presbyopia before and after the training combined with EEG and NIRS. To explore the effects of stereoscopic stimulation on the functional connectivity of brain regions and different frequency bands. To explore the scientific nature and effectiveness of glasses-free 3D visual training in the rehabilitation of presbyopia, to provide a new theoretical basis and method for the clinical treatment of presbyopia, and to provide more information and clues for exploring the complex stereo vision imaging mechanism in the fields of brain science and ophthalmology.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trail group | Experimental | Other: glasses-free 3D visual trainingConduct 15 minutes of naked-eye 3D vision training. Twice a day, five days a week. |
| Control groups | No intervention | –The subjects watched ordinary 2D videos for 15 minutes each time, all under the same lighting conditions. This was done twice a day, five days a week. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 40-60 years old, both sexes;
- refractive error -6.0D to 5.0D, astigmatism <2.0D, anisometropia <4.0D;
- binocular corrected visual acuity <0.2LogMAR;
- stereoscopic threshold ≤100 ';
- The subjects could understand the purpose of this study and sign the informed consent.
Key exclusion criteria (4 listed)
- after lens replacement; People with cataracts, which affect vision, have other eye conditions such that simultaneous vision is not possible;
- using any medication known to affect accommodative function or wearing orthokeratology lenses in the past 1 month;
- patients with severe systemic disease or severe mental illness;
- Other situations where the investigator considers that the subject should not participate in the study for safety reasons or the interests of the patient.
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 |
|---|---|---|
| glasses-free 3D visual trainingTrail group Conduct 15 minutes of naked-eye 3D vision training. Twice a day, five days a week. Control groups The subjects watched ordinary 2D videos for 15 minutes each time, all under the same lighting conditions. This was done twice a day, five days a week. | Other | Trail group |
Primary outcome
Amplitude of accommodation
Time frame: Baseline and after 6 and 12 weeks of training
The push-up method combined with negative lens method was used. The measurements were completed by a comprehensive refractometer. It was performed according to the methods in Clinical Procedures for Ocular Examination 4th
9 secondary outcomes
Asthenopia scale
Time frame: Baseline and after 6 and 12 weeks of training
Vergence facility
Time frame: Baseline and after 6 and 12 weeks of training
Accommodative convergence to accommodation(AC/A)
Time frame: Baseline and after 6 and 12 weeks of training
The node efficiency
Time frame: Baseline and after 6 and 12 weeks of training
Hemodynamic response functions
Time frame: Baseline and after 6 and 12 weeks of training
Convergence accommodation to convergence(CA/C)
Time frame: Baseline and after 6 and 12 weeks of training
Functional connectivity network
Time frame: Baseline and after 6 and 12 weeks of training
Negative relative vergence
Time frame: Baseline and after 6 and 12 weeks of training
Positive relative vergence
Time frame: Baseline and after 6 and 12 weeks of training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glasses-free 3D visual training in people with Presbyopia, 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 5 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: opening soon, as of the sponsor's last update on 3 Mar 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yehong Zhuo, professor (020-66619349, 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?
Amplitude of accommodation (time frame: Baseline and after 6 and 12 weeks of training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2025.