Effectiveness of Digital Defocus Vision Training With Low-Concentration Atropine on the Prevention and Control of Myopia in Children: A Clinical Study

Summary

Based on existing theories of myopia development and progression, our preliminary work has leveraged the features of virtual reality (VR) technology to digitally simulate myopic defocus signals through image-based emulation. Using ray-tracing techniques, we generated a constant amount of defocus on the corresponding retinal areas, employed a gradient defocus design combined with intelligent navigation to enhance defocus stimulation efficacy, and thereby developed a Digital Peripheral Defocus Training (DDVT) paradigm. In prior interventional studies, this training system demonstrated certain efficacy in controlling both axial length elongation and refractive error progression in pediatric subjects. Specifically, the control rate for refractive error progression exceeded 50%, reaching a level comparable to first-line clinical myopia control modalities, whereas the control rate for axial length elongation was approximately 45%, slightly lower than that of commonly used clinical interventions. The investigators hypothesize that this may be attributable to the paradigm's design being based solely on peripheral defocus theory, resulting in a relatively singular mechanism of action.

In the present study, we combine digital defocus training via VR devices with low-dose atropine (primarily targeting the neurotransmitter-related theory and the scleral hypoxia theory), and compare this combination against conventional defocus-based interventions (peripheral defocus design spectacles). The aim is to evaluate the combined effect of this multi-pathway, multi-target myopia control strategy on axial length and refractive error control in myopic children.

Primary Objective

To compare the effect on axial length elongation control between two different combined intervention regimens in myopic children:

1. 0.02% atropine eye drops combined with daily wear of fully corrected Defocus Incorporated Multiple Segments (DIMS) spectacles;
2. DDVT combined with 0.02% atropine eye drops and daily wear of fully corrected DIMS spectacles.

Through a 1-year follow-up, we will determine whether the change in axial length from baseline differs significantly between the two groups.

Secondary Objectives Between-group differences: To compare the 1-year changes between the two groups (DDVT + atropine + DIMS vs. atropine + DIMS) in the following parameters: refractive error (spherical equivalent), accommodative facility, positive and negative relative accommodation (PRA/NRA), uncorrected visual acuity, best-corrected visual acuity, and intraocular pressure. Additionally, to analyse the associations among these between-group differences.

Within-group changes: To evaluate the changes from baseline in each of the above parameters after 1 year of intervention within each group separately.

Conditions

• Myopia
• Prevention and Control

Interventions

OTHER

For the experimental group,Virtual reality-based digital defocus training combined with 0.02% atropine eye drops

A one-year intervention combining home-based virtual reality (VR) digital defocus training with 0.02% atropine eye drops. The protocol involves 18 minutes of daily VR training conducted 1 hour before bedtime, along with the instillation of one drop of 0.02% atropine into each eye at bedtime. Additionally, fully corrected multi-zone positive optical defocus (DIMS) spectacles are worn throughout the day for at least 10 hours daily. The total treatment duration is 1 year.

OTHER

For the control group, one drop of 0.02% atropine eye drops was instilled into each eye at bedtime daily, combined with full-time wear of fully corrected multi-zone positive optical defocus (DIMS) spe

A one-year intervention combining home-based virtual reality (VR) digital defocus training with 0.02% atropine eye drops. The protocol involves 18 minutes of daily VR training conducted 1 hour before bedtime, along with the instillation of one drop of 0.02% atropine into each eye at bedtime. Additionally, fully corrected multi-zone positive optical defocus (DIMS) spectacles are worn throughout the day for at least 10 hours daily. The total treatment duration is 1 year.

Sponsors & Collaborators

• Beijing Tongren Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-08-20

Primary Completion

2026-12-31

Completion

2027-12-31

Countries

• China

Study Locations