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

Overview

A prospective multicenter study design was adopted. Children aged 6-9 years with premyopia who met the criteria were screened and administered after completion of baseline assessment. Phase I: 0-24 weeks (0-6M). 0.01% atropine eye drops, once daily, at point in both eyes. Phase II: 24-48 weeks (6-12M). According to the rate of myopia progression at 0-24 weeks (6M), the atropine concentration was increased in steps; once daily, at point in both eyes. Group A: ( SE ≤ 0.25D), continued to maintain 0.01% atropine. Group B: (0.25D \< SE ≤ 0.375D), converted to 0.02% atropine. Group C: ( SE \> 0.375D), converted to 0.04% atropine. Followed up 5 times (0, 3, 6, 9, 12 months), collected refractive, ocular axis, intraocular pressure and other data, and recorded adverse events and cost information synchronously. Statistical analysis was carried out by covariance analysis and multivariate model, and pharmacoeconomic evaluation and drug proportion analysis were carried out.

Interventions

• Drug 0.01% Atropine
  0.01% atropine eye drops nightly both eyes

Primary outcome measures

• Change in SER at 12 months compared to baseline [Time frame: 12 month]

Secondary outcome measures (1)

• Change in AL at 12 months compared to baseline [Time frame: 12 month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07449247 · 2026KY-14

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗