NCT06995911 Virtual Far-sight Reading Device for Myopia Intervention Among Pre-myopic Children
| NCT ID | NCT06995911 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Eye Disease Prevention and Treatment Center |
| Condition | Myopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-06-01 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06995911 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 12 Years, studying Myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06995911 currently recruiting?
Yes, NCT06995911 is actively recruiting participants. Contact the research team at vvxuwei@163.com for enrollment information.
Where is the NCT06995911 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06995911 clinical trial?
NCT06995911 is sponsored by Shanghai Eye Disease Prevention and Treatment Center. The trial plans to enroll 80 participants.