CompletedPhase 4

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

China120 participantsStarted 2023-06-30

Plain-language 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.

Who can participate

Age range

4 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Axial length elongation

Timeframe: from baseline to 24 months

Trial details

NCT IDNCT07406399

SponsorBeijing Tongren Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-30

View on ClinicalTrials.gov More High Myopia trials