Slow Myopia Progression With Different Irradiance Light

NCT05881655 | Unknown DMC

• 1 other identifier: Airdoc MPC
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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 .

Conditions

Myopia, Progressive

Outcome Measures

Primary Outcomes (2)

• Mean Change of Ocular Axial length elongation at follow-up from Baseline (mm)

  Measured with IOLmaster 500 or Lenstar at follow-up from baseline

  3-month

• Mean Change of Ocular Axial length elongation at follow-up from Baseline (mm)

  Measured with IOLmaster 500 or Lenstar at follow-up from baseline

  6-month

Secondary Outcomes (5)

• Mean Change of Refractive Error at follow-up from Baseline (mm)

  3-month

• Mean Change of Refractive Error at follow-up from Baseline (mm)

  6-month

• Mean Change of Choroidal Thickness (um)

  3-month

• Mean Change of Choroidal Thickness (um)

  6-month

• Change of Fundus

  6-month

Study Arms (3)

Study Group 1

EXPERIMENTAL

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

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

Study Group 2

EXPERIMENTAL

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

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

Control Group

PLACEBO COMPARATOR

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

Device: Special Spectacles to Control Myopia

Interventions

Airdoc Red Lighting Device 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.

Also known as: Repeated Red Light, Low Lever Laser Therapy, Low Intensity Light Therapy, Photobiomodulation Therapy, Seconee, 650nm Red Light

Study Group 1; Study Group 2

Special Spectacles to Control Myopia DEVICE

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

Also known as: Essilor® Stellest™ Lenses, H.A.L.T lens

Control Group; Study Group 1; Study Group 2

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \~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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Airdoc Technology Co., Ltd.: lead
• Shanghai Children's Medical Center: collaborator

Study Sites (1)

Shanghai Children Medical Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Myopia, Degenerative

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Myopia; Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Hong Liu, MD, PHD

  Shanghai Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophia Wang, MD,PHD

CONTACT

+8618510386815; hechao@airdoc.com

Fuyu Zhang, BA

CONTACT

+8618510386815; qiukaikai0620@airdoc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2023
• First Posted: May 31, 2023
• Study Start: May 20, 2023
• Primary Completion: May 30, 2024
• Study Completion: December 30, 2025
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)