Myopia Control With Three Lever Irradiance of PBM Therapy in Children and Adults

NCT05957458 | Completed

• 1 other identifier: Airdoc MPC Co.Ltd.
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Photobiomodulation therapy, that is, Low-level red-light technology provides a new and innovative myopia control approach. This strategy enables relatively high energies of light to be delivered at much shorter durations of exposure to induce the myopia control effect. The efficacy of the low-level red-light technology has been proven in a Chinese populationb for the recent 3 years with evidence based papers and amazing results. However, there's not yet evidence to demonstrate the relationship between the dose response effect of photobiomodulation therapy on myopia control at the different age lever.

Conditions

Myopia; Amblyopia; Refractive Error - Myopia Axial; Ametropia

Keywords

Myopia; PBM therapy; LLLT

Outcome Measures

Primary Outcomes (3)

• Axial length shortening comparing to that value of baseline (mm）

  Measured with optial coherent methods with the same device assistant with the same techinician

  12-month

• Axial length shortening comparing to that value of baseline (mm）

  Measured with optial coherent methods with the same device assistant with the techinician

  1-month

• Axial length shortening comparing to that value of baseline (mm）

  Measured with optial coherent methods with the same device assistant with the same techinician

  6-month

Secondary Outcomes (1)

• Refractive changes at the follow-up from the baseline (D)

  12-month

Study Arms (4)

Moderate irradiance of PBM therapy to myopia

EXPERIMENTAL

The PBM therapy irradiance is about 0.60mW. It is asked subjects to look at the light binocularly with fusion through the pupils with natural pupils. The distance between the light and the pupils is about 5\~10cm. The treatment of each session is 3 minutes and twice daily administration while the interval time between two session is equal or larger than 4 hours with twice daily administration.

Device: Airdoc device of red light for Myopia

Extra low irradiance PBM therapy group

SHAM COMPARATOR

The PBM therapy irradiance is about 0.37mW. It is asked subjects to look at the light binocularly with fusion through the pupils with natural pupils. The distance between the light and the pupils is about 5\~10cm. The treatment of each session is 3 minutes and twice daily administration while the interval time between two session is equal or larger than 4 hours with twice daily administration.

Device: Airdoc device of red light for Myopia

high lever PBM therapy group

EXPERIMENTAL

The PBM therapy irradiance is about 1.20mW. It is asked subjects to look at the light binocularly with fusion through the pupils with natural pupils. The distance between the light and the pupils is about 5\~10cm. The treatment of each session is 3 minutes and twice daily administration while the interval time between two session is equal or larger than 4 hours with twice daily administration.

Device: Airdoc device of red light for Myopia

Control

NO INTERVENTION

Without PBM therapy group.

Interventions

Airdoc device of red light for Myopia DEVICE

This light is Narrow-Band, Long-Wavelength Lighting with three different illumination (400lux, 800lux, 1200lux) or irridiance (1.2mW, 0.6mW, 0.37mW) respectively. And the wavelength is 650nm. It allows biocular therapy.

Also known as: low lever laser therapy, photobiomodulation therapy, low lever light therapy

Extra low irradiance PBM therapy group; Moderate irradiance of PBM therapy to myopia; high lever PBM therapy group

Eligibility Criteria

• Age: 4 Years - 41 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Myopia or near Myopia with younger age
• Without other intervention of myopia control, including atropine, Misight contact lens, special design lens to control myopia, orthokeratology and other red light devices.
• Follow-up at least once
• With baseline data of ocular parameters before the follow-up

You may not qualify if:

• Photophobia
• Allergy to red light
• Severe ocular progressing diseases or systemic diseases
• The data is unacceptable with reasonable explanations

Sponsors & Collaborators

• Beijing Airdoc Technology Co., Ltd.: lead

Study Sites (1)

Qiu Jenny

Beijing, Haidian District, 100089, China

Location

Related Publications (1)

• Zhou L, Tong L, Li Y, Williams BT, Qiu K. Photobiomodulation therapy retarded axial length growth in children with myopia: evidence from a 12-month randomized controlled trial evidence. Sci Rep. 2023 Feb 27;13(1):3321. doi: 10.1038/s41598-023-30500-7.

  PMID: 36849626 BACKGROUND

MeSH Terms

Conditions

Myopia; Amblyopia; Refractive Errors

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Eye Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• QIU JENNY, MD

  Airdoc MPC Co, Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No mask for all. Open and retrospective study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three groups are all treated with PBM therapy with follow-up but they irradiance is different while one group is as the control.

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: July 24, 2023
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: May 31, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

CN (1)