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

Launched by SHANGHAI EYE DISEASE PREVENTION AND TREATMENT CENTER · May 21, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to see if a special device called the Virtual Far-sight Reading Device can help prevent or slow down myopia, which is a common vision problem that makes it hard to see far away. The study will focus on children and teenagers who are at risk of developing myopia, known as pre-myopic children. Researchers want to find out if using this device during reading or homework can make a difference and whether it is safe to use every day for up to six months.

Children between the ages of 6 and 12 years who have specific vision conditions and a family history of myopia might be eligible to join the trial. Participants will be divided into two groups: one group will use the device for at least an hour each day, while the other group will do regular reading without it. After 90 days, both groups will switch activities. During the trial, participants will have three free eye checkups, and they will be asked to report any discomfort they may feel. This study will help understand how effective this device might be in keeping children's eyes healthy.

Gender

ALL

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.