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Digital Defocus Vision Training (DDVT) System Development and Application

NCT07042022 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2026-01-06

No results posted yet for this study

Summary

Myopia is the first major disease affecting the visual health of young children. With the increase in the use of electronic products and the decrease in the time for outdoor exercise, the incidence of myopia is increasing year by year. Smith et al. firstly found that peripheral retinal defocus affects the course of myopia development in rhesus monkeys. Subsequent studies have shown that peripheral retinal hyperopic defocus can lead to the growth of the axial length (AL), leading to the development of myopia, while peripheral retinal myopic defocus can effectively slow down the growth of the AL, thus delaying the progression of myopia. Defocus signals can simultaneously change the thickness of the choroid, the vascular tissue behind the retina, and the pigment epithelium, and change the thickness and hardness of the sclera, inhibiting or promoting the growth of the axial length. Therefore, many methods have been designed to intervene in the development of myopia, including orthokeratology and peripheral defocusing glasses. The maintenance process of orthokeratology lens is complex and there is a risk of infection. Peripheral defocus glasses need to be worn for a long time, and the visual quality is unstable. It is still necessary to explore safer, more effective and more practical methods for myopia control. In addition, there may be some correlation between the development of myopia and the decrease of choroidal blood flow. Defocus signal may promote the increase of choroidal blood flow, which may be a way to prevent and control myopia.

Therefore, the investigators integrated the digital defocus paradigm into VR devices and developed a digital defocus vision training (DDVT) system. The purpose of this study was to investigate the effectiveness and safety of DDVT in the prevention and control of myopia in children.

Conditions

  • Virtual Reality Therapy

Interventions

DEVICE

Development of digital defocus vision training (DDVT)

During a six-month follow-up period, participants received 10 minutes of DDVT twice a day (once in the morning, and the other in the afternoon) using a head-mounted VR display. In daily life during non-training sessions, participants were required to wear frame glasses with complete correction.

Sponsors & Collaborators

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2025-10-01
Completion
2025-10-08

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07042022 on ClinicalTrials.gov