Clinical Study of Light Therapy to Control Myopia Progression in Children

NCT05761379 | Unknown DMC

• 1 other identifier: BeijingAirdoc
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Low-lever red light therapy (LLLT) has been used to control myopia progression in China for a few years besides amblyopia therapy for a few decades. This study is to test the efficacy of PBM therapy to myopia children as well as to compare two types of PBM therapy to control myopia progression within one month.

Conditions

Myopia, Progressive

Outcome Measures

Primary Outcomes (1)

• Changes in axial length (mm）

  Changes of axial length at 1-Month follow-up from baseline with IOLmaster 500 Axial length measurement at baseline and at follow-up with IOLmaster(Carl Zeiss). Five measurements were taken and averaged. The changes will be calculated by the formula as below: Change in axial length ( mm ) = Axial length value at follow-up baseline

  at 1-month Follow-up

Secondary Outcomes (4)

• Changes in cycloplegic autorefraction (diopters, D)

  at 1-month Follow-up and at baseline

• Changes of choroidal thickness under macular foveal (um)

  at 1-month Follow-up and at baseline

• Changes of cornea power

  at 1-month Follow-up and at baseline

• Change in retina fovea perfusion density (RFPD, %)

  at 1-month Follow-up and at baseline

Study Arms (3)

PBM therapy 1

EXPERIMENTAL

PBM therapy was performed with a low-intensity laser (Airdoc, MPC Co.,Ltd., Beijing, China) with an irradiance of 0.6±0.2 mW, a wavelength of 650 nm±10 nm, and illumination of approximately 400 lux on average. The lighting spot for therapy is a dot. Only one eye will be treated with PBM therapy.

Device: Photobiomodualtion Therapy; Device: Single vision spectacles for correction myopia

PBM therapy 2

EXPERIMENTAL

PBM therapy was performed with a low-intensity laser (Airdoc, MPC Co.,Ltd., Beijing, China) with an irradiance of 0.3±0.2 mW, a wavelength of 650 nm±10 nm, and illumination of approximately 400 lux on average. Only one eye will be treated with PBM therapy.

Device: Photobiomodualtion Therapy; Device: Single vision spectacles for correction myopia

Control

PLACEBO COMPARATOR

Single vision spectacles correction only.

Device: Single vision spectacles for correction myopia

Interventions

Photobiomodualtion Therapy DEVICE

low lever light therapy with laser semi-conductor at wavelength of 650nm

Also known as: Myopia light therapy; Low lever light therapy; Low lever laser therapy; Low intensity red light thearpy

PBM therapy 1; PBM therapy 2

Single vision spectacles for correction myopia DEVICE

Provide the distance best corrected vision acuity of refractive error of myopia for all the groups

Also known as: Glasseses

Control; PBM therapy 1; PBM therapy 2

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Grade 1 to grade 9 and age 6 to 16 years (including 6 and 16 years), Sex is not limited;
• Equivalent sphere (SER): -0.50D \~ -6.00D (including-0.50 and-6.00D);
• Best corrected vision in one eye under glasses correction: 0.1 log MAR;
• No strabismus: no more than 15 prism constant dominance strabismus after far and near cover tests;
• No myopia control measures within the previous 4 weeks: such as orthokeratology lens, gradient lens, double light lens, eye drops for myopia control (such as atropine), myopia defocus glasses, red light for myopia control, other specially designed myopia light treatment instruments or contact lenses for special design to control myopia (such as Misight);

You may not qualify if:

• Any ocular(including constant dominant strabismus with more than 15 prisms) and systemic diseases or abnormalities can significantly affect visual function or promote the progression of myopia;
• Other interventions for myopia control before 4 weeks before enrollment, For example, orthoplastic lens, gradient lens, dual-light lens, eye drops for myopia control (atropine), myopia defocus glasses, red light therapy devices for myopia control, other specially designed comprehensive treatment devices, myopia, amblyopia, or specially designed contact lenses (such as Misight), etc.
• Subject participated in other clinical trials within 4 weeks before the enrollment;
• The investigator for safety reasons or the interests of the patient, Other circumstances in which the patient should not participate in this trial, If suffering from serious heart, liver and kidney disease. -

Sponsors & Collaborators

• Beijing Airdoc Technology Co., Ltd.: lead
• Eye & ENT Hospital of Fudan University: collaborator

Study Sites (1)

Eye & ENT hospital of Fudan university

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

Related Publications (2)

• Yang W, Lin F, Li M, Wei R, Zhou J, Zhou X. Immediate Effect in the Retina and Choroid after 650 nm Low-Level Red Light Therapy in Children. Ophthalmic Res. 2023;66(1):312-318. doi: 10.1159/000527787. Epub 2022 Oct 31.

  PMID: 36315988 BACKGROUND

• Liu G, Li B, Rong H, Du B, Wang B, Hu J, Zhang B, Wei R. Axial Length Shortening and Choroid Thickening in Myopic Adults Treated with Repeated Low-Level Red Light. J Clin Med. 2022 Dec 17;11(24):7498. doi: 10.3390/jcm11247498.

  PMID: 36556114 BACKGROUND

MeSH Terms

Conditions

Myopia, Degenerative

Condition Hierarchy (Ancestors)

Myopia; Refractive Errors; Eye Diseases

Study Officials

• Xingtao Zhou, M.D. PhD.

  Eye & ENT Hospital of Fudan University

  STUDY CHAIR

• Weicun Chen, MD, PhD

  Eye & ENT Hospital of Fudan University

  STUDY DIRECTOR

• Meiyan Li, MD, PhD

  Eye & ENT Hospital of Fudan University

  STUDY DIRECTOR

Central Study Contacts

Jenny Qiu, M.D.

CONTACT

+8618510386815; qiukaikai0620@airdoc.com

Chao He, Ph.D.

CONTACT

hechao@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

Model Details: Low lever red light therapy with Model : Sky-n1201c at the wavelength of 650nm; 3 minutes illumination for both eyes, administered twice daily at the interview of 4 hours. Children in the red light therapy group wore single vision spectacles the entire day and under red light therapy (power, 0.6mW; wavelength, 650nm; Beijing Airdoc MPC Co. Ltd, Beijing, China) twice per day for 3 minutes each session, with at least a 4-hour interval between sessions. There were no specific guidelines for room illumination. After the first measurement session, each child returned for follow-up examinations at 1, 3, and 6 months and completed all the aforementioned examinations.

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: March 9, 2023
• Study Start: March 28, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)