Clinical trial NCT06853691: The Effects of Glasses-Free 3D Training on Visual and Cognitive Function in Presbyopic Individuals
Official title: The Effects of Glasses-Free 3D Training on Visual and Cognitive Function in Presbyopic Individuals
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Presbyopia
Keywords: Presbyopia
visual training
EEG
fNIRS
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Amplitude of accommodation
timeFrame: Baseline and after 6 and 12 weeks of training
Secondary outcomes:
measure: Asthenopia scale
timeFrame: Baseline and after 6 and 12 weeks of training
measure: Vergence facility
timeFrame: Baseline and after 6 and 12 weeks of training
measure: Accommodative convergence to accommodation(AC/A)
timeFrame: Baseline and after 6 and 12 weeks of training
measure: The node efficiency
timeFrame: Baseline and after 6 and 12 weeks of training
measure: Hemodynamic response functions
timeFrame: Baseline and after 6 and 12 weeks of training
measure: Convergence accommodation to convergence(CA/C)
timeFrame: Baseline and after 6 and 12 weeks of training
measure: Functional connectivity network
timeFrame: Baseline and after 6 and 12 weeks of training
measure: Negative relative vergence
timeFrame: Baseline and after 6 and 12 weeks of training
measure: Positive relative vergence
timeFrame: Baseline and after 6 and 12 weeks of training
Other outcomes:
measure: Accommodative facility
timeFrame: Baseline and after 6 and 12 weeks of training
measure: Refraction and addition(near correction)
timeFrame: Baseline and after 6 and 12 weeks of training
measure: Near point of convergence
timeFrame: Baseline and after 6 and 12 weeks of training
Locations:
city: Guangzhou
country: China
facility: Zhongshan Opthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References: