Effectiveness of Digital Defocus Vision Training With Low-Concentration Atropine on the Prevention and Control of Myopia in Children: A Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Axial Length (AL)
研究概览
简要总结
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:
- 0.02% atropine eye drops combined with daily wear of fully corrected Defocus Incorporated Multiple Segments (DIMS) spectacles;
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •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.
排除标准
- •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.
结局指标
主要结局
Axial Length (AL)
时间窗: Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)
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.
次要结局
- 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))
- Intraocular Pressure (IOP)(Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days))
研究者
Jinyuan,MD
President of Beijing Tongren Hospital, Chief Physician of Ophthalmology Department
Beijing Tongren Hospital