Actively Recruiting

Phase Not Applicable
Age: 6Years - 13Years
All Genders
NCT05756959

Myopia Control Combined PBM With Myopic Defocus Lens in Children

Led by Beijing Airdoc Technology Co., Ltd. · Updated on 2023-03-09

304

Participants Needed

1

Research Sites

263 weeks

Total Duration

On this page

Sponsors

B

Beijing Airdoc Technology Co., Ltd.

Lead Sponsor

T

The First People's Hospital of Xuzhou

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Myopia Control Combined PBM With Myopic Defocus Lens in Children

Who Can Participate

Age: 6Years - 13Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Informed consent by the supervision of the children
  • Age between 6 and 13 years old (including both 6 and 13)
  • Spherical equivalent (SE) range between -0.50 and -5.50 diopters
  • Astigmatism of 2.00 diopters or less
  • Best corrected visual acuity (BCVA) of 0.8 or better
  • Anisometropia of 1.50 diopters or less
  • No previous use of other myopia control interventions
Not Eligible

You will not qualify if you...

  • Ocular lesions or diseases affecting vision such as cataract, glaucoma, macular pathology, cornea lesions, uveitis, retina detachment, congenital optic abnormalities
  • Conditions like halo, glare, tinnitus, ADHD, psoriasis
  • Systemic diseases including immune disease, central nervous system disorders, Down syndrome, asthma, severe cardiopulmonary abnormalities, severe liver or kidney dysfunction
  • Squint, ocular lesions, or acute inflammation
  • Use of other myopia control interventions within the last 3 months, including atropine, devices, orthokeratology, multifocal soft lenses, or multifunction spectacles

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

the first people's hospital of Xuzhou

Xuzhou, Jiangsu, China, 210000

Actively Recruiting

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Research Team

Y

Ying Li, MD, PHD

CONTACT

L

Lei Qiao, PHD, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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