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Completed

NCT Number: NCT07406399

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.

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Key information

Conditions

High Myopia Children Low Concentration Atropine Soft Contact Lens

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Tongren Eye Center, Beijing Tongren Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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 (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

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.

Primary outcomes

  1. Axial length elongation

    Time frame: from baseline to 24 months

    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.

Secondary outcomes

  1. Change in cycloplegic spherical equivalent refraction

    Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months.

    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.

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

A Randomized Controlled Study of Low Concentration Atropine Combined With Soft Contact Lens in Controlling Myopia Progression in Children With High Myopia

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 12, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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