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

NCT07406399 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-02-12

No results posted yet for this study

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

Interventions

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

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

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.

Sponsors & Collaborators

  • Beijing Tongren Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2025-11-30
Completion
2026-01-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07406399 on ClinicalTrials.gov