An interventional study of glasses-free 3D visual training in Presbyopia, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Not yet recruiting at 1 site in China. Open to participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Other
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
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.
336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.
This study's planned enrollment of 60 is close to the median of 61 across 276 interventional studies indexed under Presbyopia.
Browse Presbyopia studies →Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Conduct 15 minutes of naked-eye 3D vision training. Twice a day, five days a week.
Other: glasses-free 3D visual training
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.
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.
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
Time frame: Baseline and after 6 and 12 weeks of training
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 ")
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Baseline and after 6 and 12 weeks of training
Accommodative facility
Accommodative facility was tested using a lens flipper (+0.5D/-0.5 D lens combination) at 1m with distance correction
Time frame: Baseline and after 6 and 12 weeks of training
Refraction and addition(near correction)
In a semi-dark room, the Subjective Refraction and addition(ADD) measurements were performed. Thus, the subjects' near correction prescription were obtained
Time frame: Baseline and after 6 and 12 weeks of training
Near point of convergence
Near point of convergence was measured using push-up method with near correction
Time frame: Baseline and after 6 and 12 weeks of training
Plan to share: No
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Start is estimated for Feb 2025; primary completion for Dec 2025, 10 months later.
Of 42 non-industry interventional studies with no phase under Presbyopia, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 23. This study's planned 10 months is below that.
Counting every sponsor, half of 129 studies reached it within 10 months; a quarter within 3 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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