Virtual Far-sight Reading Device for Myopia Intervention Among Pre-myopic Children
NCT ID: NCT06995911
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2025-06-01
2026-05-31
Brief Summary
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Main questions:
Can using the Virtual Far-sight Reading Device reduce the risk of myopia? Is the device safe to use every day for up to 6 months?
What we'll do:
Researchers will compare two groups of children:
Group A: Uses the device for reading/writing (at least 1 hour daily) Group B: Does regular reading/writing without the device After 90 days, the groups will switch to see if the results stay the same.
Participants will:
* Have free eye checkups 3 times over 6 months
* Use the device during homework time (if in the desk group)
* Report any eye discomfort or problems
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Detailed Description
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This study employs a randomized controlled crossover trial to evaluate the efficacy and safety of the device in pre-myopic children and adolescents. Participants are divided into Groups A and B, with Phase I (Days 0-90) requiring Group A to perform daily near-work activities using the device for ≥60 minutes of cumulative daily use, while Group B follows conventional near-work practices without intervention. During Phase II (Days 91-180), the interventions are reversed between groups. Comprehensive ophthalmic evaluations are conducted at baseline, Day 90, and Day 180 to assess changes in spherical equivalent refraction (SER), axial length (AL), myopia incidence rate, binocular visual function parameters, and ocular morphological metrics, ensuring rigorous analysis of both therapeutic outcomes and safety profiles.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
Phase I (Day 0-90):
Group A: Performed daily near-work activities (e.g., reading/writing) using the Virtual Far-sight Reading Device with cumulative daily use ≥60 minutes.
Group B: Engaged in routine near-work activities without intervention.
Phase II (Day 90-180):
Group A: Switched to standard near-work practice without device use.
Group B: Initiated Virtual Far-sight Reading Device intervention under identical protocol (≥60 min/day cumulative use).
PREVENTION
NONE
Study Groups
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Nearwork with the Virtual Far-sight Reading Device
Virtual Far-sight Reading Device
The Virtual Far-sight Reading Device utilizes a birdbath optical configuration and freeform surface technology to extend the working distance from 30 cm to over 6 meters, thereby simulating distance viewing conditions and maintaining ciliary muscle relaxation. Study participants were required to engage in reading and writing tasks using the device for a cumulative daily duration of at least 1 hour.
Nearwork without the Virtual Far-sight Reading Device
No interventions assigned to this group
Interventions
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Virtual Far-sight Reading Device
The Virtual Far-sight Reading Device utilizes a birdbath optical configuration and freeform surface technology to extend the working distance from 30 cm to over 6 meters, thereby simulating distance viewing conditions and maintaining ciliary muscle relaxation. Study participants were required to engage in reading and writing tasks using the device for a cumulative daily duration of at least 1 hour.
Eligibility Criteria
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Inclusion Criteria
* Worse eye cycloplegic spherical equivalent refraction (SER): -0.5 D \< SER ≤ +0.75 D; Cylinder ≤ -1.5 D in both eyes; Interocular anisometropia ≤ 1.5 D ③ Visual acuity: Best-corrected visual acuity (BCVA) ≤ 0.1 logMAR in both eyes. ④ Family history: At least one parent with myopia.
* Intraocular pressure (IOP): 10-21 mmHg in both eyes; Interocular IOP difference ≤ 5 mmHg
⑥ Compliance: Commitment to daily home use of the Far-Image Light Field Desk per protocol, immediate notification to investigators if unable to comply, and completion of scheduled follow-ups.
⑦ Informed consent: Signed assent form (minor) and written informed consent from legal guardian.
Exclusion Criteria
* Systemic diseases: Immune/CNS disorders; Down syndrome; Severe cardiopulmonary/hepatic/renal dysfunction; Uncontrolled asthma
* Ocular abnormalities: Manifest strabismus; Binocular vision dysfunction; Pathological ocular changes or active ocular inflammation ④ Recent myopia interventions (within 3 months prior to screening): Orthokeratology; multifocal contact lenses; Functional spectacles, red-light therapy
⑤ Medications affecting efficacy evaluation (within 3 months): Anticholinergics (e.g., atropine, pirenzepine); Cholinergics (e.g., pilocarpine)
⑥ Participation in other clinical trials within 3 months.
⑦ Contraindications/allergies to cycloplegics or study-related medications.
⑧ Chronic psychiatric disorders or cognitive impairment.
⑨ Other conditions deemed unsuitable by investigators.
6 Years
12 Years
ALL
No
Sponsors
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Shanghai Eye Disease Prevention and Treatment Center
OTHER
Responsible Party
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Locations
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Shanghai Eye Disease Prevention and Treatment Center
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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YMZSSJLY202501
Identifier Type: -
Identifier Source: org_study_id
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