Slow Myopia Progression With Different Irradiance Light

NCT ID: NCT05881655

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-20
• Study Completion Date: 2025-12-30

Brief Summary

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 .

Detailed 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.

Conditions

Myopia, Progressive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Group 1

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

Group Type: EXPERIMENTAL

Airdoc Red Lighting Device

Intervention Type: DEVICE

A medical device with ultra low lever laser irradiance of 0.6mW or 1.2mW at the surface of cornea. And the therapy lasts 3 minutes with the 4 hours or more interval of break.

Special Spectacles to Control Myopia

Intervention Type: DEVICE

Customer designed power and fitting to each subject for all the study periods.

Study Group 2

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

Group Type: EXPERIMENTAL

Airdoc Red Lighting Device

Intervention Type: DEVICE

A medical device with ultra low lever laser irradiance of 0.6mW or 1.2mW at the surface of cornea. And the therapy lasts 3 minutes with the 4 hours or more interval of break.

Special Spectacles to Control Myopia

Intervention Type: DEVICE

Customer designed power and fitting to each subject for all the study periods.

Control Group

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

Group Type: PLACEBO_COMPARATOR

Special Spectacles to Control Myopia

Intervention Type: DEVICE

Customer designed power and fitting to each subject for all the study periods.

Interventions

Airdoc Red Lighting Device

A medical device with ultra low lever laser irradiance of 0.6mW or 1.2mW at the surface of cornea. And the therapy lasts 3 minutes with the 4 hours or more interval of break.

Intervention Type: DEVICE

Special Spectacles to Control Myopia

Customer designed power and fitting to each subject for all the study periods.

Intervention Type: DEVICE

Other Intervention Names

Repeated Red Light, Low Lever Laser Therapy, Low Intensity Light Therapy, Photobiomodulation Therapy, Seconee, 650nm Red Light; Essilor® Stellest™ Lenses; H.A.L.T lens

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Children's Medical Center

OTHER

Sponsor Role: collaborator

Beijing Airdoc Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hong Liu, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Children's Medical Center

Locations

Shanghai Children Medical Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Sophia Wang, MD,PHD

Role: CONTACT

hechao@airdoc.com

+8618510386815

Fuyu Zhang, BA

Role: CONTACT

qiukaikai0620@airdoc.com

+8618510386815

Facility Contacts

Shanghai Children Medical Center Zhang, MD

Role: primary

qiukaikai0620@airdoc.com

+8618510386815

Other Identifiers

Airdoc MPC

Identifier Type: -

Identifier Source: org_study_id