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.

Study Overview

• Status: Completed
• Conditions: Children; High Myopia; Soft Contact Lens; Low Concentration Atropine
• Intervention / Treatment: Device: soft peripheral defocus contact lenses; Drug: Atropine 0.04%; Device: Single Vision Spectacles; Drug: Atropine (0.01%)

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Tongren Eye Center, Beijing Tongren Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: combination therapy group; 40 patients in combination therapy group received atropine 0.04% plus soft peripheral defocus contact lenses	Device: soft peripheral defocus contact lenses; Multifocal soft contact lenses with peripheral defocus design have shown promise in reducing axial elongation. They work by reducing peripheral hyperopic defocus, which is thought to drive eye growth; Drug: Atropine 0.04%; Low-concentration atropine eyedrops (atropine 0.04% and atropine 0.01% used in this trial) are the only consistently effective pharmacological treatment for myopia control
Experimental: atropine monotherapy group; 40 patients in atropine monotherapy group received atropine 0.04% plus spectacles	Drug: Atropine 0.04%; Low-concentration atropine eyedrops (atropine 0.04% and atropine 0.01% used in this trial) are the only consistently effective pharmacological treatment for myopia control; Device: Single Vision Spectacles; Single Vision Spectacles are the most commonly used device in high myopia children, which demonstrate better pediatric compliance, eliminate infection risks, and involve lower long-term costs.
Placebo Comparator: control group; 40 patients in control group received atropine 0.01% plus spectacles	Device: Single Vision Spectacles; Single Vision Spectacles are the most commonly used device in high myopia children, which demonstrate better pediatric compliance, eliminate infection risks, and involve lower long-term costs.; Drug: Atropine (0.01%); Low-concentration atropine eyedrops (atropine 0.04% and atropine 0.01% used in this trial) are the only consistently effective pharmacological treatment for myopia control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length elongation	Axial length will be measured using the IOLMaster 500 optical biometry system (Carl Zeiss Meditec, Jena, Germany). To ensure measurement reliability and minimize random error, five consecutive measurements will be obtained for each eye at each visit, with individual measurements required to have a signal-to-noise ratio ≥2.0. The mean value of these five measurements will be calculated and used for analysis. Measurements will be standardized by time of day, conducted between 1:00 PM and 5:00 PM at all visits to minimize the influence of diurnal variations in axial length.	from baseline to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cycloplegic spherical equivalent refraction	The change in spherical equivalent refraction (SE = sphere + cylinder/2) under cycloplegia, measured from baseline. Cycloplegia will be induced using compound tropicamide eyedrops per a standardized protocol and confirmed by pupil diameter (≥6 mm) and light reflex assessment. Refraction will then be measured using an autorefractor (Topcon KR-8800). Five measurements will be taken per eye, and the mean SE will be calculated from readings with a divergence of less than 0.25 D.	Baseline, 6 months, 12 months, 18 months, and 24 months.

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2023
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): January 30, 2026

Study Registration Dates

• First Submitted: February 1, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 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: TREC2022-KY110

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
• product manufactured in and exported from the U.S.: No