Digital Defocus Vision Training (DDVT) System Development and Application

NCT07042022 | Completed DMC

• 1 other identifier: 2023KYPJ282
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• the axial length （AL）

  The axial length of the eye is the distance from the anterior surface of the cornea to the posterior surface of the retina. In a normal adult, it is approximately 24 mm , and its growth is closely related to myopia . AL was measured using the IOL Master (Carl Zeiss 500, Meditec, Oberkochen, Germany)

  1 year

Secondary Outcomes (1)

• spherical equivalent refraction

  1 year

Other Outcomes (3)

• Negative relative accommodation

  1 year

• Positive relative accommodation

  1 year

• The accommodation facility

  1 year

Study Arms (2)

DDVT training group

EXPERIMENTAL

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.

Device: Development of digital defocus vision training (DDVT)

control group

NO INTERVENTION

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

Interventions

Development of digital defocus vision training (DDVT) 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.

DDVT training group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

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

Guangzhou, Guangdong, 510060, China

Location

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

Beijing, 100730, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: June 7, 2025
• First Posted: June 27, 2025
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 8, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-06

Locations

CN (2)