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

February 24, 2025 updated by: Zhongshan Ophthalmic Center, Sun Yat-sen University
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Zhongshan Opthalmic Center, Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Amplitude of accommodation
Time Frame: Baseline and after 6 and 12 weeks of training
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Asthenopia scale
Time Frame: Baseline and after 6 and 12 weeks of training
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
Time Frame: Baseline and after 6 and 12 weeks of training
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)
Time Frame: Baseline and after 6 and 12 weeks of training
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
Time Frame: Baseline and after 6 and 12 weeks of training

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
Time Frame: Baseline and after 6 and 12 weeks of training
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)
Time Frame: Baseline and after 6 and 12 weeks of training
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
Time Frame: Baseline and after 6 and 12 weeks of training

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
Time Frame: Baseline and after 6 and 12 weeks of training
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
Time Frame: Baseline and after 6 and 12 weeks of training
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Accommodative facility
Time Frame: Baseline and after 6 and 12 weeks of training
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)
Time Frame: Baseline and after 6 and 12 weeks of training
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
Time Frame: Baseline and after 6 and 12 weeks of training
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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