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The Effects of Glasses-Free 3D Training on Visual and Cognitive Function in Presbyopic Individuals

The Effects of Glasses-Free 3D Training on Visual and Cognitive Function in Presbyopic Individuals

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06853691
Enrollment
60
Registered
2025-03-03
Start date
2025-02-27
Completion date
2026-01-01
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Presbyopia

Keywords

Presbyopia, visual training, EEG, fNIRS

Brief 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. 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.

Interventions

OTHERglasses-free 3D visual training

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.

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

The recruitment, grouping, training, and follow-up data collection of subjects were conducted by two different researchers, and the specific grouping information was announced after the end of the study. Any analysis conducted before the study was completed was only marked with simple symbols such as 1 and 2, and was marked by researchers who did not participate in data collection, sorting, and analysis.

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age 40-60 years old, both sexes; 2. refractive error -6.0D to 5.0D, astigmatism \<2.0D, anisometropia \<4.0D; 3. binocular corrected visual acuity \<0.2LogMAR; 4. stereoscopic threshold ≤100 '; 5. The subjects could understand the purpose of this study and sign the informed consent.

Exclusion criteria

1. after lens replacement; People with cataracts, which affect vision, have other eye conditions such that simultaneous vision is not possible; 2. using any medication known to affect accommodative function or wearing orthokeratology lenses in the past 1 month; 3. patients with severe systemic disease or severe mental illness; 4. Other situations where the investigator considers that the subject should not participate in the study for safety reasons or the interests of the patient.

Design outcomes

Primary

MeasureTime frameDescription
Amplitude of accommodationBaseline and after 6 and 12 weeks of trainingThe 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

Secondary

MeasureTime frameDescription
The node efficiencyBaseline and after 6 and 12 weeks of trainingElectroencephalogram (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.
Functional connectivity networkBaseline and after 6 and 12 weeks of trainingElectroencephalogram (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.
Negative relative vergenceBaseline and after 6 and 12 weeks of trainingNegative relative vergence were measured by base in prism at 40cm with near correction
Positive relative vergenceBaseline and after 6 and 12 weeks of trainingPositive relative vergence were measured by base out prism at 40cm with near correction
Asthenopia scaleBaseline and after 6 and 12 weeks of trainingThe 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 )
Vergence facilityBaseline and after 6 and 12 weeks of trainingVergence facility was tested using a lens flipper (3△BI/12△BO lens combination per eye) at 40cm with near correction
Accommodative convergence to accommodation(AC/A)Baseline and after 6 and 12 weeks of trainingAccommodative response was measured by WAM-5500. Additional accommodative and vergence stimuli were provided by spherical lenses
Hemodynamic response functionsBaseline and after 6 and 12 weeks of trainingFunctional 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.
Convergence accommodation to convergence(CA/C)Baseline and after 6 and 12 weeks of trainingAccommodative response was measured by WAM-5500,Additional accommodative and vergence stimuli were provided by prisms

Other

MeasureTime frameDescription
Near point of convergenceBaseline and after 6 and 12 weeks of trainingNear point of convergence was measured using push-up method with near correction
Refraction and addition(near correction)Baseline and after 6 and 12 weeks of trainingIn a semi-dark room, the Subjective Refraction and addition(ADD) measurements were performed. Thus, the subjects' near correction prescription were obtained
Accommodative facilityBaseline and after 6 and 12 weeks of trainingAccommodative facility was tested using a lens flipper (+0.5D/-0.5 D lens combination) at 1m with distance correction

Countries

China

Contacts

Primary ContactYehong Zhuo, professor
zhuoyh@mail.sysu.edu.cn020-66619349
Backup ContactJinan Zhan
zhanjan@mail2.sysu.edu.cn15015072151

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026