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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Presbyopia
• Intervention / Treatment: Other: glasses-free 3D visual training

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yehong Zhuo, professor; Phone Number: 020-66619349; Email: zhuoyh@mail.sysu.edu.cn
• Study Contact Backup: Name: Jinan Zhan; Phone Number: 15015072151; Email: zhanjan@mail2.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhongshan Opthalmic Center, Sun Yat-sen University
      • Contact: Yehong Zhuo, professor; Phone Number: 020-66619349; Email: zhuoyh@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trail group; Conduct 15 minutes of naked-eye 3D vision training. Twice a day, five days a week.	Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline and after 6 and 12 weeks of training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 ")	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	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	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.	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.	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	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.	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	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	Baseline and after 6 and 12 weeks of training

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accommodative facility	Accommodative facility was tested using a lens flipper (+0.5D/-0.5 D lens combination) at 1m with distance correction	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	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	Baseline and after 6 and 12 weeks of training

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): February 27, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: EEG; fNIRS; Presbyopia; visual training
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: 2024KYPJ113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No