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

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Axial Length (AL) [Срок оценки: Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)]

Вторичные конечные точки (6)

• Spherical Equivalent Refraction (SE) [Срок оценки: Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)]
• Accommodative Facility [Срок оценки: Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)]
• Negative and Positive Relative Accommodation [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)]
• Intraocular Pressure (IOP) [Срок оценки: Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing — Пекин

Идентификаторы

NCT: NCT07724210 · TREC2026-KY131

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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