Atropine (0.02%, 0.04%) Combined With Defocus DIMS for Moderate and High Myopia Control (NCT06523504) | Clinical Trial Compass
RecruitingPhase 1/2
Atropine (0.02%, 0.04%) Combined With Defocus DIMS for Moderate and High Myopia Control
China410 participantsStarted 2024-02-01
Plain-language 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.
Who can participate
Age range6 Years – 12 Years
SexALL
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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
* Secondary myopia (such as premature retinopathy or other eye diseases in infants and children caused secondary myopia), or myopia combined with systemic syndrome (such as Marfan syndrome)
* Had internal eye surgery (such as cataract extraction, intraocular lens implantation, anti-glaucoma surgery, etc.)
* Refractive medium opacity (such as corneal disease, crystal opacity, etc.)
* Bnormal intraocular pressure and clinical significance (IOP \<10 mmHg or IOP \>21mmHg or binocular IOP differen…