Virtual Far-sight Reading Device for Pre-myopia in Children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests a novel Virtual Far-sight Reading Device designed to simulate long-distance viewing during near-work to slow myopia progression in children aged 6–12 with pre-myopia. It uses a randomized, crossover design where participants switch between using the device and standard near-work after 90 days, with ophthalmic evaluations at baseline, day 90, and day 180. Outcomes focus on changes in refraction and eye health, along with safety and tolerability over time. Compliance, daily use, and potential eye discomfort are monitored, and free eye checkups are provided during the trial.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Eye Disease Prevention and Treatment Center
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Wei Xu, Prof
• Email: vvxuwei@163.com
• Phone: +86 18521513008

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.