Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06232161

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

9 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ningbo Eye Hospital

Ningbo, Zhejiang, 315000, China

About this study

Interventions and visits All spectacle lenses were made for single focus with full correction for each subject as the first intervention throughout the whole procedure for both groups. PBM 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 at the first 12 month. At the second 12 months, non-randomized cohorts continued according to the willing to use the device from both groups. Once decided, those usage would be followed up for another 12 months for tracking the change of axial length as well as the change of refractive error. All the adverse effects and any harms are encouraged to report during the next 12 months' study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Repeated low-level red-light (RLRL) therapy, Low intensity red light (laser) therapy, Photobiomodulation therapy (PBM) therapy

Spectacles

Device

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

Primary outcomes

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

    Time frame: 12-month

    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

Secondary outcomes

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

    Time frame: 12-month

    The change of refractive error (D) from the follow-up of each 12-month from the baseline. The right eye were considered for the comparison

Sponsors and collaborators

Lead sponsor

Beijing Airdoc Technology Co., Ltd.

Industry

Collaborators

  • Ningbo Eye Hospital

Registry information

Official study title

Retrospective,2-Year Post-Trial Follow-up Study of Sustained and Rebound Effect of Red-light Therapy for Myopia in Ningbo.

Important dates

Study start
2020
Primary completion
2024
Study completion
2026
First posted
Jan 30, 2024
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.