Sustained Effect of Red-light Therapy for Myopia Control: A 2-Year Post-Trial Follow-up Study

NCT06232161 | Active Not Recruiting

• 1 other identifier: Ningbo EYE Hospital
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the long-term efficacy and safety of red-light therapy for myopia control over 2 years, and the potential rebound effect after treatment cessation. The Chinese myopic children who originally completed the one-year randomised controlled trial in the previous study were enrolled. Children continued or started to daily usage of red-light therapy were defined as the RL group, while those who stopped using red-light therapy and switched to single-vision spectacles (SVS) as well as those who continued to keep single-vision spectacles in the second year were both regarded as the SVS group. Red-light therapy was provided by an at-home desktop light device emitting red-light of 650 nm and was administered for 3 min at a time, twice a day. Changes in axial length (AL) and cycloplegic spherical equivalence refraction (SER) are to be measured and compared as well as the adverse effects including the rebound effect. Red-light therapy has emerged as a novel myopia control treatment modality recently. A 12-month randomised controlled trial (RCT) conducted by our research team was thought to be earlier to evaluate the treatment of myopic children using red-light therapy. The trial demonstrated that PBM therapy was effective on myopia control, reducing axial elongation and spherical equivalence refraction (SER) progression 103% and 127% compared with single vision spectacle (SVS) over a 12-month period, respectively. The promising efficacy of red-light therapy has been further confirmed in other studies. In addition, satisfactory user acceptability and no unrecovered functional and structural damages were observed. Myopia generally progresses throughout childhood and hence a study duration of 1 year is not sufficient to widely adopt the red-light therapy as a treatment strategy for myopia control. The sustainability of treatment efficacy, rebound phenomenon upon cessation of treatment, and potential risks and adverse effects in myopic children with longer-term PBM therapy, remain to be fully elucidated. Thus, the aims of this post-trial follow-up study were to invite the participants to come back for a 24-month visit and to investigate the long-term efficacy and safety of continued red-light therapy as well as the potential rebound effect following red-light treatment cessation.

Conditions

Myopia

Keywords

myopia, red-light therapy

Outcome Measures

Primary Outcomes (1)

• Change of axial length (mm) with the measurement of device named by IntraOcular Lens Master(IOLmaster 500)

  The change of axial length (mm) from the 24 months and 12 months from the baseline for each subject; The right eye were considered for the comparison between groups. The change value is recorded of the average from 5 values at the same follow-up

  12-month

Secondary Outcomes (1)

• Change of refractive error (D) with cycloplegic refraction with the same autorefractor

  12-month

Study Arms (2)

red-light therapy group

EXPERIMENTAL

The red-light therapy group would be treated with red-light therapy twice daily including the single focus spectacles during the follow-up.

Device: Red-light therapy device; Device: Spectacles

control group

OTHER

The control group including both the stopping red-light therapy group from the first 12 months (who obtained red-light therapy but stopped during the second 12-month follow-up) and those never use red-light therapy.

Device: Spectacles

Interventions

Red-light therapy device DEVICE

Red-light therapy was performed with a low-intensity laser (LD-A, Jilin LD Optoelectronics Technology, Jilin, China) with an irradiance of 0.35 ± 0.02 mW/cm2, a wavelength of 650 nm ± 10 nm, and illumination of approximately 400 lux on average.

Also known as: Repeated low-level red-light (RLRL) therapy, Low intensity red light (laser) therapy, Photobiomodulation therapy (PBM) therapy

red-light therapy group

Spectacles DEVICE

Single focus spectacles, that is to say, wearing glasseses with minus power lens

control group; red-light therapy group

Eligibility Criteria

• Age: 9 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of myopia;
• Ages of 9\~13 years old;
• Must be with best corrected visual acuity ≥20/25 (decimal record);
• Must be the subject in the previous study of 12-month red-light therapy of myopia;

You may not qualify if:

• Clinical diagnosis of glaucoma or retinal lesions;
• Clinical diagnosis of optic media lesions (e.g., central thick corneal scars, cataract);
• Clinical diagnosis of optic nerve dysfunction;
• Clinical diagnosis of amblyopia;
• Must be eligible for follow-up.

Sponsors & Collaborators

• Beijing Airdoc Technology Co., Ltd.: lead
• Ningbo Eye Hospital: collaborator

Study Sites (1)

Ningbo Eye Hospital

Ningbo, Zhejiang, 315000, 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 RESULT

Related Links

• The first 12-month follow-up report of PBM therapy

MeSH Terms

Conditions

Myopia

Interventions

Therapeutics; Lasers; Low-Level Light Therapy; Eyeglasses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Laser Therapy; Phototherapy; Lenses

Study Officials

• LEI ZHOU, M.D.

  Ningbo Eye Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Myopia control officer

Model Details: The first 12-month follow-up were parallel of two groups: treatment group and control group with randomized and single blind; While the second 12-month follow-up were chosen to be in the treatment group or in the control group depended on the willingness of red-light therapy from both patients and their family.

Study Record Dates

• First Submitted: January 20, 2024
• First Posted: January 30, 2024
• Study Start: May 13, 2020
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

CN (1)