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

2026. július 20. frissítette: Jinyuan,MD, Beijing Tongren Hospital

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.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

100

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

  • Kína
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kína, 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

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Gyermek

Egészséges önkénteseket fogad

Igen

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Megelőzés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Egyetlen

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 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.
Egyéb: 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.
Aktív összehasonlító: 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.
Egyéb: 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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Axial Length (AL)
Időkeret: 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.
Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Spherical Equivalent Refraction (SE)
Időkeret: Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)
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.
Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)
Accommodative Facility
Időkeret: Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)
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.
Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)
Negative and Positive Relative Accommodation
Időkeret: Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)
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.
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)
Időkeret: Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)
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.
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)
Időkeret: Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)

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)
Intraocular Pressure (IOP)
Időkeret: Baseline, Month 1 (±7 days of training), Month 6 (±14 days of training), 1 year post-training (±30 days)

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)

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Beijing Tongren Hospital

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. augusztus 20.

Elsődleges befejezés (Becsült)

2026. december 31.

A tanulmány befejezése (Becsült)

2027. december 31.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. július 20.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. július 20.

Első közzététel (Tényleges)

2026. július 24.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. július 24.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. július 20.

Utolsó ellenőrzés

2026. július 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • TREC2026-KY131

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

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Nem

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