Myopia Control Combined PBM With Myopic Defocus Lens in Children

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

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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