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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pre-myopia
• Intervention / Treatment: Drug: 0.01% Atropine

• Study Type: Interventional
• Enrollment (Estimated): 233
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Meinan He; Phone Number: 02286428750; Email: hmn509@tmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

1. A written informed consent form signed by the child and their legal guardian has been obtained.
2. Children aged 6 to 9 years (inclusive).
3. 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.
4. After bilateral ciliary muscle paralysis, the astigmatism detected by computerized refraction is ≤1.00D.
5. Anisometropia ≤1.5D.
6. No other organic lesions affecting visual acuity in both eyes.
7. Unaided visual acuity ≥0.8.
8. Ocular intraocular pressure (IOP) ≤21 mmHg.

Exclusion criteria:

1. 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.).
2. Systemic diseases: Immune system disorders, central nervous system diseases, Down syndrome, asthma, severe cardiopulmonary dysfunction, and a history of severe hepatic or renal dysfunction.
3. Bilateral or unilateral ocular involvement with dominant strabismus or any other pathological ocular changes or acute inflammatory eye diseases.
4. 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.
5. 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.
6. Patients with hypersensitivity to atropine, cipretosil, or other drugs used in this study.
7. Exclude participants who have participated in other drug clinical trials within the past 3 months.
8. Other circumstances deemed unsuitable by the investigator.
9. Individuals with chronic mental disorders or psychiatric abnormalities.
10. Those with an adjustment range below 8D.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.01% atropine; 0.01% atropine eye drops nightly both eyes	Drug: 0.01% Atropine; 0.01% atropine eye drops nightly both eyes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in SER at 12 months compared to baseline	Change in SER at 12 months compared to baseline	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in AL at 12 months compared to baseline	Change in AL at 12 months compared to baseline	12 month

Collaborators and Investigators

• Sponsor: Tianjin Medical University Eye Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds; Alkaloids; Aza Compounds; Heterocyclic Compounds, Bridged-Ring; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Atropine
• Other Study ID Numbers: 2026KY-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No