Low Concentration Atropine Combined With Soft Contact Lens in Controlling Myopia Progression in Children With High Myopia

NCT07406399 | Completed Phase 4

• 1 other identifier: TREC2022-KY110
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

High Myopia; Low Concentration Atropine; Soft Contact Lens; Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in cycloplegic spherical equivalent refraction

  Baseline, 6 months, 12 months, 18 months, and 24 months.

Study Arms (3)

combination therapy group

EXPERIMENTAL

40 patients in combination therapy group received atropine 0.04% plus soft peripheral defocus contact lenses

Device: soft peripheral defocus contact lenses; Drug: Atropine 0.04%

atropine monotherapy group

EXPERIMENTAL

40 patients in atropine monotherapy group received atropine 0.04% plus spectacles

Drug: Atropine 0.04%; Device: Single Vision Spectacles

control group

PLACEBO COMPARATOR

40 patients in control group received atropine 0.01% plus spectacles

Drug: Atropine (0.01%); Device: Single Vision Spectacles

Interventions

soft peripheral defocus contact lenses DEVICE

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

combination therapy group

Atropine 0.04% DRUG

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

atropine monotherapy group; combination therapy group

Atropine (0.01%) DRUG

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

control group

Single Vision Spectacles DEVICE

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.

atropine monotherapy group; control group

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Eye Center, Beijing Tongren Hospital

Beijing, China

Location

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Generation of random sequences, determination of random number grouping, and inclusion of subjects by different staff members.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: February 12, 2026
• Study Start: June 30, 2023
• Primary Completion: November 30, 2025
• Study Completion: January 30, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)