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Recruiting NCT05756959

NCT05756959 Myopia Control Combined PBM With Myopic Defocus Lens in Children

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Clinical Trial Summary
NCT ID NCT05756959
Status Recruiting
Phase
Sponsor Beijing Airdoc Technology Co., Ltd.
Condition Myopia, Progressive
Study Type INTERVENTIONAL
Enrollment 304 participants
Start Date 2022-12-12
Primary Completion 2027-08-01

Eligibility & Interventions

Sex All sexes
Min Age 6 Years
Max Age 13 Years
Study Type INTERVENTIONAL
Interventions
PBMPeripheral defocus spectaclesSingle vision spectacles

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 304 participants in total. It began in 2022-12-12 with a primary completion date of 2027-08-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

To study the efficacy of myopi control with two methods: low lever red light and peripheral defocus spectacles with four groups and design with prospective, double-blind, randimized, and with control for 6 month.

Eligibility Criteria

Inclusion Criteria: * Informed consent by the supervision of the children * 6\~13 years old (including both the 6 and 13) * SE range: -0.50\~-5.50D * Astigmatism \<=2.00D * BCVA \>=0.8 * Anisometropia \<=1.50D * Confirmed to no use of other myopia control intervention Exclusion Criteria: * Ocular lesions to effect vision or diseases (such as cataract, glaucoma, marcular pathology, cornea lesions, uveitis, retina detachment, congential opitc abnormal and etc.) * Halo, glare, toutic, ADHD, psoriasis * Systom disease: immune disease, central nerve system, Down syndrome, asthma, severe cardiopulmonary abnormal, severe liver and renal dysfunction. * Squint, ocular lesion or acute imflammation. * Other myopia control interventions within recent 3 month such as atropine, device, orthokeratology, multi-focus soft lens, multi-function spectacles.

Contact & Investigator

Central Contact

Ying Li, MD, PHD

✉ 834582241@qq.com

📞 +8615162130727

Principal Investigator

Yan Wang, BA

STUDY DIRECTOR

The First People's Hospital of Xuzhou

Frequently Asked Questions

Who can join the NCT05756959 clinical trial?

This trial is open to participants of all sexes, aged 6 Years or older, up to 13 Years, studying Myopia, Progressive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05756959 currently recruiting?

Yes, NCT05756959 is actively recruiting participants. Contact the research team at 834582241@qq.com for enrollment information.

Where is the NCT05756959 trial being conducted?

This trial is being conducted at Xuzhou, China.

Who is sponsoring the NCT05756959 clinical trial?

NCT05756959 is sponsored by Beijing Airdoc Technology Co., Ltd.. The principal investigator is Yan Wang, BA at The First People's Hospital of Xuzhou. The trial plans to enroll 304 participants.

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