NCT06523504 Atropine (0.02%, 0.04%) Combined With Defocus DIMS for Moderate and High Myopia Control
| NCT ID | NCT06523504 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Ruihua Wei |
| Condition | Myopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 410 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2026-03-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
To evaluate the effectiveness and safety of DIMS, low concentration atropine eye drops,and atropine combined with DIMS in controlling axial length and refraction in children with moderate to high myopia.
Eligibility Criteria
Inclusion Criteria: * School-age children aged 6 to 12 years (including boundary value) * Children with moderate or high myopia (subjective refraction after cycloplegia: -9.00D≤spherical equivalent (SE)≤-3.00D, with-rule astigmatism (C)≤2.00D, against-rule astigmatism (C)≤1.00D, anisometropia of both eyes≤2.50D) * Binocular best corrected visual acuity (BCVA)≥0.8 (five-point visual acuity 4.9) * Agree with the study scheme and sign the informed consent * Note: if both eyes meet the inclusion criteria, the eye with higher spherical equivalent is the study eye; if one eye meets the inclusion criteria, the eye is the study eye. Exclusion Criteria: * Used or currently using orthokeratology, multifocal contact lenses, defocusing framework lenses, atropine eye drops and other myopia control means in the past month; used red light treatment in the past * Children with obvious strabismus and amblyopia * With congenital eye disease, such as congenital cataract, congenital retinal disease * Seco