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

NCT ID: NCT06853691

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-27
• Study Completion Date: 2026-01-01

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.

Conditions

Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Trail group

Conduct 15 minutes of naked-eye 3D vision training. Twice a day, five days a week.

Group Type: EXPERIMENTAL

glasses-free 3D visual training

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

glasses-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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Opthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Yehong Zhuo, professor

Role: CONTACT

zhuoyh@mail.sysu.edu.cn

020-66619349

Jinan Zhan

Role: CONTACT

zhanjan@mail2.sysu.edu.cn

15015072151

Facility Contacts

Yehong Zhuo, professor

Role: primary

zhuoyh@mail.sysu.edu.cn

020-66619349

Other Identifiers

2024KYPJ113

Identifier Type: -

Identifier Source: org_study_id