Digital Defocus Vision Training (DDVT) System Development and Application

NCT ID: NCT07042022

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-10-08

Brief 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

Study Design

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

Study Groups

DDVT training group

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 virtual reality (VR) display. In daily life during non-training sessions, participants were required to wear frame glasses with complete correction.

Group Type: EXPERIMENTAL

Development of digital defocus vision training (DDVT)

Intervention Type: DEVICE

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.

control group

The control group did not have any myopia prevention and control intervention in half a year, and only wore complete-corrected frame glasses in daily life

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• children aged 6 to 12 years
• diagnosis of myopia with SER of -0.75 to -6.00 D
• regular astigmatism, and astigmatism less than 2.50D
• anisometropia less than 1.50 D
• a logMAR best-corrected visual acuity (BCVA) of 0.00 or better
• an understanding by participants and their legal guardians of the purpose of the study

Exclusion Criteria

• other myopia control therapies in the last 6 months (including but not limited to atropine and orthokeratology)
• strabismus, amblyopia, congenital lens dislocation, congenital cataract, glaucoma, uveitis, nystagmus, keratoconus, eye neoplasms and other ocular diseases
• systemic diseases such as nephrotic syndrome or diabetes
• structural changes in the eyeball, a history of ocular surgery or trauma
• other systemic diseases affecting eye health
• participants in other clinical trials at the same time.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Jin Yuan

PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Sun Yat-Sen Universit

Guangzhou, Guangdong, China

Beijing Ophthalmology and Visual Sciences Key Laboratory, Beijing Tongren Eye Center

Beijing, , China

Countries

China

Other Identifiers

2023KYPJ282

Identifier Type: -

Identifier Source: org_study_id