A Randomized Controlled Clinical Trial on the Efficacy and Safety of the Virtual Far-sight Reading Device for Myopia Intervention in Pre-myopic Children
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
• 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.