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

NCT06853691 | Not Yet Recruiting DMC

• 1 other identifier: 2024KYPJ113
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Presbyopia

Keywords

Presbyopia; visual training; EEG; fNIRS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Asthenopia scale

  Baseline and after 6 and 12 weeks of training

• Vergence facility

  Baseline and after 6 and 12 weeks of training

• Accommodative convergence to accommodation(AC/A)

  Baseline and after 6 and 12 weeks of training

• The node efficiency

  Baseline and after 6 and 12 weeks of training

• Hemodynamic response functions

  Baseline and after 6 and 12 weeks of training

Other Outcomes (3)

• Accommodative facility

  Baseline and after 6 and 12 weeks of training

• Refraction and addition(near correction)

  Baseline and after 6 and 12 weeks of training

• Near point of convergence

  Baseline and after 6 and 12 weeks of training

Study Arms (2)

Trail group

EXPERIMENTAL

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

Other: glasses-free 3D visual training

Control groups

NO INTERVENTION

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.

Interventions

glasses-free 3D visual training 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.

Trail group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Zhongshan Opthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Yehong Zhuo, professor

CONTACT

020-66619349; zhuoyh@mail.sysu.edu.cn

Jinan Zhan

CONTACT

15015072151; zhanjan@mail2.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: March 3, 2025
• Study Start: February 27, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 1, 2026
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)