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

NCT07449247 | Not Yet Recruiting Phase 1

• 1 other identifier: 2026KY-14
• Study Type: interventional
• Target: 233
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pre-myopia

Outcome Measures

Primary Outcomes (1)

• Change in SER at 12 months compared to baseline

  Change in SER at 12 months compared to baseline

  12 month

Secondary Outcomes (1)

• Change in AL at 12 months compared to baseline

  12 month

Study Arms (1)

0.01% atropine

EXPERIMENTAL

0.01% atropine eye drops nightly both eyes

Drug: 0.01% Atropine

Interventions

0.01% Atropine DRUG

0.01% atropine eye drops nightly both eyes

0.01% atropine

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Eye Hospital: lead

MeSH Terms

Interventions

Atropine

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Central Study Contacts

Meinan He

CONTACT

02286428750; hmn509@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share