Slow Myopia Progression With Different Irradiance Light

Beijing Airdoc Technology

Status: Enrolling

Conditions: Myopia, Progressive

Treatments: Device: Special Spectacles to Control Myopia; Device: Airdoc Red Lighting Device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05881655

Airdoc MPC

Details and patient eligibility

About

It is a prospective clinical control study on red light control myopia with specail design spectacles for 75 children in 3 groups. Study Groups with two different powers of 0.6 mW and 1.2 mW at wavelength of 650nm. The control group is to wear the same brand and design spectalces as those two study groups. In addition, the progression of myopia is usually accompanied by the changes in a variety of ocular parameters, such as refractive error, reduced submacular choroidal thickness, and prolonged length of the ocular axis length.The goal is to test which power (1.2mW and 0.6mW) is better in myopic children for 3 month's follow-up and also to test how to get better result with the increaing or decreasing lighting power for the total 6 month follow-up results .

Full description

It is a prospective clinical control study on red light control myopia with specail design spectacles for 75 children in 3 groups. Each group has 25 myopic children. Study Groups with two different powers of 0.6 mW and 1.2 mW at wavelength of 650nm are randomized to be allocated into the 3 groups. The control group is to wear the same brand and design spectalces as those two study groups. In addition, the progression of myopia is usually accompanied by the changes in a variety of ocular parameters, such as refractive error, reduced submacular choroidal thickness, and prolonged length of the ocular axis length. All groups will be wearing a special lens named by Stellest with high aspherical lens design.

Enrollment: 75 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 6~12 years old
• Refractive Error of Myopia within -0.50 D~-5.00 D, Anisometropia less or equal to 2.00D, The best corrected vision acuity is better or equal to 0.8 （decimal record).
• Written consent formed with supervisions and children with 6 month follow-up.

Exclusion criteria

• Photophobia or allergy to any cycloplegic eyedrops (such as tropcaine, cyclopentolate).
• Lesions in fundus or any part of eyeball with abnormal corrected vision such as keratoconus.
• Strabisumus with angles large or equal to 5 prism dioper.
• With other myopia control device such as atropine, Orthokeratology, Misight lens or other myopia control device.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups, including a placebo group

Study Group 1

Experimental group

Description:

With 1.2mW lighting power of red light at wavelenth of 650nm and wearing H.A.L.T lens to control myopia.

Treatment:

Device: Airdoc Red Lighting Device

Device: Special Spectacles to Control Myopia

Study Group 2

Experimental group

Description:

With 0.6mW lighting power of red light at wavelenth of 650nm and wearing H.A.L.T lens to control myopia.

Treatment:

Device: Airdoc Red Lighting Device

Device: Special Spectacles to Control Myopia

Control Group

Placebo Comparator group

Description:

Wearing H.A.L.T lens to control myopia only.

Treatment:

Device: Special Spectacles to Control Myopia