Effectiveness of Digital Defocus Vision Training With Low-Concentration Atropine on the Prevention and Control of Myopia in Children: A Clinical Study
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
- Jiný: For the experimental group,Virtual reality-based digital defocus training combined with 0.02% atropine eye drops
- Jiný: 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
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Jing Zhong
- Telefonní číslo: +8618501186181
- E-mail: zhongjing_90@163.com
Studijní místa
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Beijing Municipality
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Beijing, Beijing Municipality, Čína, 100730
- 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
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: VR visual training for 18 minutes per day (performed 1 hour before bedtime) + instillation of one dr
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.
|
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.
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Aktivní komparátor: For the control group, one drop of 0.02% atropine eye drops was instilled into each eye at bedtime d
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.
|
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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Axial Length (AL)
Časové okno: Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)
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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.
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Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Spherical Equivalent Refraction (SE)
Časové okno: Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)
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Spherical equivalent refraction is defined as the optical lens power required to correct refractive errors (myopia, hyperopia, and astigmatism) for the left and right eyes, as determined by subjective refraction using a phoropter.
In this trial, SER measurements were performed by the same experienced examiner, who was masked to treatment allocation, using the same Topcon phoropter under full cycloplegia.
Only changes in SER of the right eye were analyzed.
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Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)
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Accommodative Facility
Časové okno: Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)
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Accommodative facility is an important clinical measure of visual function that assesses the ability to rapidly relax and stimulate accommodation in response to different accommodative demands-i.e., the flexibility and speed of the accommodative response.
It is typically measured using a flipper bar (e.g., ±2.00 D lenses).
Under full distance correction, the subject views a target while alternately flipping the positive and negative lenses, and the number of successful cycles completed within one minute is recorded.
Normal values are ≥8 cycles/min for binocular facility and ≥11 cycles/min for monocular facility.
In this trial, accommodative facility measurements were performed by the same experienced examiner, who was masked to treatment allocation, using the same flipper bar.
Only changes in accommodative facility of the right eye were analyzed.
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Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)
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Negative and Positive Relative Accommodation
Časové okno: Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)
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Negative relative accommodation (NRA) is defined as the accommodation relaxed when both eyes are stimulated by positive lenses while viewing a near target.
Positive relative accommodation (PRA) is defined as the accommodation generated when both eyes are stimulated by negative lenses while viewing a near target.Measurements of PRA and NRA were performed by the same experienced examiner, who was masked to treatment allocation, using the same Topcon phoropter after full correction of refractive error.
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Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)
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Uncorrected Visual Acuity (Visus Sine Correctore, SC)
Časové okno: Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)
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Visus sine correctore (SC, also known as uncorrected visual acuity) describes the capacity of the tested eye to clearly distinguish optotypes at a standardized testing distance without any optical corrective lenses.
Results are conventionally recorded in decimal or logarithmic format.
All SC visual acuity assessments are conducted under identical standardized ambient conditions by the same experienced examiner with a unified standard visual acuity chart (e.g., ETDRS or Snellen chart), to ensure objectivity and consistency of all testing procedures.
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Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)
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Best Corrected Visual Acuity (Visus Cum Correctore, BCVA)
Časové okno: Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)
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Best Corrected Visual Acuity (BCVA, Latin: visus cum correctore) is defined as the maximal visual acuity achievable after full correction of the subject's ocular refractive error, including spherical and cylindrical ametropia. All measurements are performed under standardized illumination conditions. The same masked senior examiner instructs subjects to wear fully corrective lenses prescribed via precise refraction using an auto phoropter (e.g., Topcon). Testing is conducted with standard logarithmic visual acuity charts (ETDRS or standard Snellen charts) under full refractive correction. This testing protocol ensures visual acuity outcomes solely reflect the intrinsic function of the visual system by eliminating confounding effects from refractive errors, thereby securing accuracy and comparability of all trial data. |
Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)
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Intraocular Pressure (IOP)
Časové okno: Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)
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Intraocular pressure (IOP) refers to the pressure exerted by the intraocular contents against the inner wall of the eyeball, measured in millimeters of mercury (mmHg). It is a key physiological parameter for evaluating ocular health, particularly the risk of glaucoma. In this study, all IOP measurements are performed under standardized conditions by the same masked senior examiner using a single calibrated non-contact tonometer. Prior to measurement, subjects' eyes are confirmed to be free of external irritation to obtain stable and reliable readings, ensuring the accuracy and validity of data for intra-group and inter-group comparisons. |
Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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Více informací
Termíny související s touto studií
Klíčová slova
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