Myopia Control Combined PBM With Myopic Defocus Lens in Children

Last updated: March 7, 2023
Sponsor: Beijing Airdoc Technology Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myopia

Treatment

N/A

Clinical Study ID

NCT05756959
Xuzhou First People's Hospital
  • Ages 6-13
  • All Genders

Study 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

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

Exclusion Criteria:

  • Ocular lesions to effect vision or diseases (such as cataract, glaucoma, marcularpathology, cornea lesions, uveitis, retina detachment, congential opitc abnormal andetc.)
  • Halo, glare, toutic, ADHD, psoriasis
  • Systom disease: immune disease, central nerve system, Down syndrome, asthma, severecardiopulmonary 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.

Study Design

Total Participants: 304
Study Start date:
December 12, 2022
Estimated Completion Date:
December 31, 2027

Study Description

myopic children with age from 6 13 years old. And refraction from -0.50D-5.50D.

The red light is low lever laser therapy at wavelength of 650nm.

Connect with a study center

  • the first people's hospital of Xuzhou

    Xuzhou, Jiangsu 210000
    China

    Active - Recruiting

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