Low Concentration Atropine Combined With Soft Contact Lens in Controlling Myopia Progression in Children With High Myopia

A Randomized Controlled Study of Low Concentration Atropine Combined With Soft Contact Lens in Controlling Myopia Progression in Children With High Myopia

Peripheral contact lens in controlling myopia progression in high myopia children（PAM）is a prospective, single-center, randomized controlled trial with three parallel arms conducted at Beijing Tongren Hospital. Chinese children aged 6-12 years with high myopia (spherical equivalent ≤-6.0D) and annual progression ≥0.75D will be enrolled. Participants will be randomized 40:40:40 to: (1) combination therapy group receiving atropine 0.04% plus soft peripheral defocus contact lenses; (2) atropine monotherapy group receiving atropine 0.04% plus spectacles; or (3) control group receiving atropine 0.01% plus spectacles. The primary outcome is change in axial length and cycloplegic refraction at 24 months. Secondary outcomes include changes in pupil diameter, and safety parameters.

Inclusion Criteria:

• Mainland Chinese children aged 4-16 years at enrollment
• Spherical equivalent refraction ≤-6.0D in both eyes under cycloplegia
• Astigmatism ≤2.5D in both eyes
• Anisometropia ≤2.5D
• Best corrected visual acuity ≥0.1 logMAR in both eyes
• Subject-reported non-significant ocular and systemic medical history
• Ability and willingness to wear contact lenses (for intervention groups)
• Written informed consent from parents/guardians and assent from child
• Ability to attend all scheduled follow-up visits

Exclusion Criteria:

• Previous use of myopia control treatments (atropine, orthokeratology, multifocal lenses) within 3 months
• Current use of systemic medications affecting pupil size or accommodation
• Known allergies to atropine or contact lens materials
• Current use of systemic medications that may significantly affect contact lens wear, tear film production, pupil size, adaptability, or refractive status.
• Ocular diseases: strabismus, amblyopia, glaucoma, cataract, corneal disease
• Systemic diseases affecting ocular health
• History of ocular surgery or trauma
• Inability to perform study procedures
• Participation in other clinical trials within 2 months