💬In plain words
What the trial is, and whether it could suit you
This clinical trial wants to find out if the Virtual Far-sight Reading Device can help prevent or slow down myopia progression in children and teenagers with pre-myopia. We also want to know what makes this treatment work better for some participants and check for any eye or body-related side effects over time.
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Age: 6-12 years (inclusive), gender unrestricted.
* 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:
* Ocular comorbidities affecting vision/refractive development: Marfan syndrome; Lens pathologies (e.g., cataracts); Glaucoma; retinal detachment; retinopathy of prematurity
* 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.
💊
What it tests
- Virtual Far-sight Reading Device
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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