PROTECT-Study: Prospective Research on Optimizing Atropine Concentration Escalation for Children's Myopia Prevention

Inclusion criteria

• A written informed consent form signed by the child and their legal guardian has been obtained.
• Children aged 6 to 9 years (inclusive).
• Equivalent spherical diopter of computerized refraction after bilateral ciliary muscle paralysis: 0D<SE. The upper limit standards for SE are set as follows for different age groups: 6 years old: P25 = +1.13D,7 years old: P25 = +1.00D,8 years old: P25 = +0.88D,9 years old: P25 = +0.63D.
• After bilateral ciliary muscle paralysis, the astigmatism detected by computerized refraction is ≤1.00D.
• Anisometropia ≤1.5D.
• No other organic lesions affecting visual acuity in both eyes.
• Unaided visual acuity ≥0.8.
• Ocular intraocular pressure (IOP) ≤21 mmHg.

Exclusion criteria

• Subjects who may have ocular diseases affecting vision or refractive errors (such as lens damage diseases like cataract, glaucoma, macular degeneration, corneal lesions, uveitis, retinal detachment, severe vitreous opacity, etc.).
• Systemic diseases: Immune system disorders, central nervous system diseases, Down syndrome, asthma, severe cardiopulmonary dysfunction, and a history of severe hepatic or renal dysfunction.
• Bilateral or unilateral ocular involvement with dominant strabismus or any other pathological ocular changes or acute inflammatory eye diseases.
• Patients who have undergone myopia control treatments, including pharmacological therapy (e.g., atropine or piperazine), orthokeratology, multifocal soft lenses, multifocal hard lenses, functional eyeglass frames, or red light therapy.
• Exclude patients who have used drugs affecting efficacy evaluation (e.g., anticholinergic agents: atropine, piperazine; cholinergic agents: pilocarpine) for systemic or local use within the preceding 3 months.
• Patients with hypersensitivity to atropine, cipretosil, or other drugs used in this study.
• Exclude participants who have participated in other drug clinical trials within the past 3 months.
• Other circumstances deemed unsuitable by the investigator.
• Individuals with chronic mental disorders or psychiatric abnormalities.
• Those with an adjustment range below 8D.