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Myopia Control Combined PBM With Myopic Defocus Lens in Children

B

Beijing Airdoc Technology

Status

Enrolling

Conditions

Myopia, Progressive

Treatments

Device: Single vision spectacles
Device: Peripheral defocus spectacles
Device: PBM

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05756959
Xuzhou First People's Hospital

Details and patient eligibility

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.

Full 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.

Enrollment

304 estimated patients

Sex

All

Ages

6 to 13 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

304 participants in 4 patient groups, including a placebo group

PBM therapy + SVS
Experimental group
Description:
Low lever red light therapy with single vision spectacles
Treatment:
Device: PBM
Device: Single vision spectacles
Peripheral defocus spectacles
Experimental group
Description:
a spectacles with special design with peripheral myopic defocus to control myopia progression
Treatment:
Device: Peripheral defocus spectacles
PBM +Peripheral defocus spectacles
Experimental group
Description:
Low lever red light therapy with a spectacles with special design with peripheral myopic defocus to control myopia progression
Treatment:
Device: PBM
Device: Peripheral defocus spectacles
Control
Placebo Comparator group
Description:
single vision spectacles only as the control
Treatment:
Device: Single vision spectacles

Trial contacts and locations

1

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Central trial contact

Ying Li, MD, PHD; Lei Qiao, PHD, MD

Data sourced from clinicaltrials.gov

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