Status:
NOT_YET_RECRUITING
Virtual Far-sight Reading Device for Myopia Intervention Among Pre-myopic Children
Lead Sponsor:
Shanghai Eye Disease Prevention and Treatment Center
Conditions:
Myopia
Pre-myopia
Eligibility:
All Genders
6-12 years
Phase:
NA
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 make...
Detailed Description
The Virtual Far-sight Reading Device is an innovative ocular protection device integrating advanced far-image optical technology, designed to alleviate asthenopia and prevent myopia progression by sim...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06995911
Start Date
June 1 2025
End Date
May 31 2026
Last Update
May 30 2025
Active Locations (1)
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1
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, China