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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-13

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Influencing Factors of Repeated Low-level Red-light in Myopia

NCT07104513

Myopia

ACTIVE_NOT_RECRUITING

A Real-world Study of 650nm Low-intensity Single-wavelength Red Light for Children and Adolescents

NCT05832723

Myopia

RECRUITING

Effectiveness and Safety of Repeated Low-Level Red-Light Therapy on Myopia Control Among Children and Adolescents

NCT05871840

Myopia

UNKNOWN

The Effectiveness and Safety of Low-intensity Single-wavelength Red Light in Controlling High Myopia in Children and Adolescents：A Randomized, Controlled, Multicenter Clinical Trial

NCT05184621

Age 3 to 16 Years (Inclusive), Male or Female Clinical Diagnosis Confirming That Myopia Has Occurred in at Least One Eye The Guardian Voluntarily Signed the Subject's Informed Consent Form

COMPLETED NA

650nm Low-level Red-light for Myopia Control and Prevention in Children

NCT05786586

Myopia

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

red-light therapy group

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

Group Type EXPERIMENTAL

Red-light therapy device

Intervention Type 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.

Spectacles

Intervention Type DEVICE

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

control group

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.

Group Type OTHER

Spectacles

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Red-light therapy 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.

Intervention Type DEVICE

Spectacles

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Repeated low-level red-light (RLRL) therapy Low intensity red light (laser) therapy Photobiomodulation therapy (PBM) therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

9 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes