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

NCT07724210 | Not Yet Recruiting

• 1 other identifier: TREC2026-KY131
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.0.02% atropine eye drops combined with daily wear of fully corrected Defocus Incorporated Multiple Segments (DIMS) spectacles;
2. 2.DDVT combined with 0.02% atropine eye drops and daily wear of fully corrected DIMS spectacles.

Conditions

Myopia; Prevention and Control

Keywords

Myopia、Virtual Reality、 Peripheral Defocus、Low-concentration Atropine、 Myopia Prevention and Control

Outcome Measures

Primary Outcomes (1)

• Axial Length (AL)

  Axial length is defined as the anteroposterior diameter of the eyeball and is a key parameter for assessing ocular refractive status. Generally, each 1-mm increase in axial length corresponds to an approximate increase of 200-300 diopters of myopia. In this trial, axial length measurements were performed by the same experienced examiner, who was masked to treatment allocation, using the same IOLMaster 500 device. Only changes in axial length of the right eye were compared.

  Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)

Secondary Outcomes (6)

• Spherical Equivalent Refraction (SE)

  Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)

• Accommodative Facility

  Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)

• Negative and Positive Relative Accommodation

  Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)

• Uncorrected Visual Acuity (Visus Sine Correctore, SC)

  Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)

• Best Corrected Visual Acuity (Visus Cum Correctore, BCVA)

  Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)

Study Arms (2)

VR visual training for 18 minutes per day (performed 1 hour before bedtime) + instillation of one dr

EXPERIMENTAL

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

For the control group, one drop of 0.02% atropine eye drops was instilled into each eye at bedtime d

ACTIVE COMPARATOR

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) spectacles for at least 10 hours per day during waking hours.

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

Interventions

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

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.

VR visual training for 18 minutes per day (performed 1 hour before bedtime) + instillation of one dr

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 OTHER

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.

For the control group, one drop of 0.02% atropine eye drops was instilled into each eye at bedtime d

Eligibility Criteria

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

You may qualify if:

• Children and adolescents aged 6 to 12 years with bilateral myopia; the right eye is selected as the study eye.
• Cycloplegic refraction performed within 1 month prior to baseline visit meets the following ocular refractive criteria: spherical equivalent refraction ranging from -1.00 D to -6.00 D (inclusive), astigmatism ≤ 2.00 D, and anisometropia ≤ 1.00 D.
• Bilateral best corrected visual acuity (BCVA) ≥ 0.8.
• Participants in the experimental group agree to complete 18-minute daily VR accommodative defocus training at home (1 hour before bedtime), combined with one drop of 0.02% atropine ophthalmic solution instilled in each eye every night before bedtime, and wear fully corrected multi-zone positive optical defocus spectacles for no less than 10 hours per day throughout the study period. Participants in the control group agree to instill one drop of 0.02% atropine ophthalmic solution in each eye every night before bedtime and wear fully corrected multi-zone positive optical defocus spectacles for no less than 10 hours per day throughout the study period. All participants shall promptly notify the investigator if they are unable to comply with the above study regimens.
• Able to complete all scheduled follow-up examinations at baseline, Month 1, Month 6, and Month 12 as required.
• The participant and their legal guardian fully understand the study protocol, agree to participate in the clinical trial, and provide written informed consent.

You may not qualify if:

• Received any myopia control treatment within 6 months prior to screening, including but not limited to atropine eye drops, orthokeratology lenses, and phototherapy instruments.
• Received flip lens training within 6 months prior to screening.
• Diagnosed with ocular diseases including strabismus, amblyopia, nystagmus, ocular tumors, congenital glaucoma, congenital cataract, or other organic eye disorders.
• Have a history of ocular surgery or ocular trauma, including corneal transplantation, corneal suture surgery, pediatric cataract surgery, and pediatric glaucoma surgery.
• Have systemic diseases that may affect ocular health, including Marfan syndrome, Marchesani syndrome, Down syndrome, craniocerebral trauma, epilepsy, spastic paralysis, and other related systemic disorders.
• Concurrent participation in any other interventional clinical trial.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing Key Laboratory of Intelligent Diagnosis Technology and Equipment for Optic Nerve-Related Eye Diseases, National Engineering Research Center for Ophthalmology

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Myopia

Interventions

SpeA protein, Streptococcus pyogenes

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Jing Zhong

CONTACT

+8618501186181; zhongjing_90@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Beijing Tongren Hospital, Chief Physician of Ophthalmology Department

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 24, 2026
• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)