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Clinical Trials in China / NCT06995911
Recruiting Not applicable

Virtual Far-sight Reading Device for Myopia Intervention Among Pre-myopic Children

NCT06995911 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Eye Disease Prevention and Treatment Center
Phase
Not applicable
Started
2025-06-01
Last updated
2026-05-26

Condition(s) studied

MyopiaPre-myopia

Investigational drug(s) / intervention(s)

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.

Study 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

Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Eye Disease Prevention and Treatment Center Shanghai China Recruiting

More Shanghai Eye Disease Prevention and Treatment Center trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06995911 on ClinicalTrials.gov ↗ ← All trials in China