Red-light Therapy for Near-sightedness

Overseen By Jonathan Li, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Strabismus, Ocular abnormalities, Severe disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 12 months

90 Participants Needed

Trial Summary

What is the purpose of this trial?

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 population. This trial demonstrated that 3-minutes per session twice a day repeated low-level red-light treatment controlled 87.7% of refraction progression and 76.8% of axial length elongation when the time of compliance to the treatment was 75%. Repeating this RCT in culturally diverse groups will confirm and translate this technology into a solution for myopia control globally.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have been treated for myopia control before, you may not be eligible to participate.

What data supports the idea that Red-light Therapy for Near-sightedness is an effective treatment?

The available research shows that Red-light Therapy for Near-sightedness, also known as RLRL therapy, is effective in controlling myopia in children. One study compared RLRL therapy to a sham device and found it effective in slowing down the progression of myopia. Another study compared RLRL therapy to low-dose atropine eye drops, a common alternative treatment, and evaluated their effectiveness. Additionally, a meta-analysis of randomized controlled trials supports the idea that RLRL therapy can help manage myopia by affecting eye growth. These studies suggest that RLRL therapy is a promising treatment for controlling myopia in children. ^{1 2 3 4 5}

What safety data exists for red-light therapy for near-sightedness?

The safety of repeated low-level red-light (RLRL) therapy for myopia control has been assessed in several studies, including randomized controlled trials and meta-analyses. These studies aimed to evaluate both the efficacy and safety of RLRL therapy in children with myopia. While the primary focus was on efficacy, safety was also a key consideration in these trials, indicating that safety data has been collected and analyzed as part of these studies. ^{1 2 3 6 7}

Is the treatment Red-light Therapy a promising treatment for Near-sightedness?

Yes, Red-light Therapy is a promising treatment for Near-sightedness. Studies show it can help control myopia in children by affecting eye growth and vision changes. It has been compared to other treatments and shows potential benefits in managing myopia progression. ^{1 2 3 8 9}

Research Team

Jonathan Li, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for kids aged 8-13 with near-sightedness (myopia) between -1.00 and -5.00 diopters, less than 1.50 diopters of anisometropia, and up to 2.50 diopters of astigmatism who speak English and have good corrected vision. It's not for those with eye abnormalities, previous myopia treatments, or severe disabilities.

Inclusion Criteria

Corrected monocular logMAR visual acuity (VA): 1.0 or better

Fluent in English

Consent to participate in random allocation of grouping

Exclusion Criteria

I have received treatments for myopia control in the past.

My doctor thinks I shouldn't join due to severe health or cognitive issues.

Noncompliance with treatment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low-level red light treatment twice a day from Monday to Friday, with each treatment lasting for 3 minutes at a minimal interval of 4 hours

12 months

Daily treatments, follow-up visits at 1, 3, 6, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up visits at 1, 3, 6, and 12 months

Treatment Details

Interventions

• Low-level Red Light Therapy Device

Trial Overview The study tests a low-level red-light therapy device as a treatment for myopia in children from diverse backgrounds by having them undergo short light sessions twice daily to see if it can control the progression of their near-sightedness effectively.

Participant Groups

Group I: Low Level Red Light Treatment Arm Experimental Treatment 1 Intervention

On top of wearing single vision spectacles, subjects in the intervention group will receive low-level red light treatment twice a day from Monday to Friday, with each treatment lasting for 3 minutes at a minimal interval of 4 hours.

Low-level Red Light Therapy Device is already approved in China for the following indications:

Approved in China as Low-Level Red Light Therapy Device for:

• Myopia control in children

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

University of Melbourne

Collaborator

Trials

193

Recruited

1,287,000+

Findings from Research

In a randomized, double-blind study of 112 children aged 7 to 12, repeated low-level red-light (RLRL) therapy significantly reduced myopia progression compared to a sham device, with a mean change in spherical equivalence refraction of 0.06 D in the RLRL group versus -0.11 D in the sham group (P = 0.003).

RLRL therapy also resulted in less axial elongation (0.02 mm increase) compared to the sham group (0.13 mm increase), and importantly, no adverse effects were reported, indicating the treatment is both effective and safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myopia Control Effect of Repeated Low-Level Red-Light Therapy in Chinese Children: A Randomized, Double-Blind, Controlled Clinical Trial. Dong, J., Zhu, Z., Xu, H., et al.[2023]

A meta-analysis of seven randomized controlled trials involving 1,031 children aged 6 to 16 years found that repeated low-level red light (RLRL) therapy significantly reduced axial length (AL) by an average of 0.25 mm, indicating its effectiveness in slowing myopia progression.

RLRL therapy also significantly increased cycloplegic spherical equivalent refraction (SER) by 0.60 D, further supporting its role in managing myopia in children compared to control treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeated Low-Level Red Light Therapy for the Control of Myopia in Children: A Meta-Analysis of Randomized Controlled Trials. Wang, F., Peng, W., Jiang, Z.[2023]

In a study involving 62 children aged 7 to 15, repeated low-level red light (RLRL) therapy significantly reduced the progression of axial length (AL) compared to 0.01% atropine eye drops, with a mean difference of -0.24 mm over 12 months (P < 0.001).

RLRL therapy also showed a much lower rate of myopia progression, with 53.2% of children experiencing less than 0.1 mm change in AL, compared to only 9.7% in the atropine group, indicating that RLRL is a more effective treatment option for myopia control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy Comparison of Repeated Low-Level Red Light and Low-Dose Atropine for Myopia Control: A Randomized Controlled Trial. Chen, Y., Xiong, R., Chen, X., et al.[2022]

In a study involving 25 children, 3 minutes of low-level red light therapy (LLRLT) resulted in a significant short-term increase in retinal fovea perfusion density (RFPD) 5 minutes after treatment, suggesting a potential benefit for retinal blood flow.

However, this increase in RFPD was temporary, returning to baseline levels within an hour, and no significant changes were observed in other retinal and choroidal parameters, indicating that while LLRLT may have a transient effect, its long-term impact on eye health remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate effect in retina and choroid after 650 nm low-level red light therapy in children. Yang, W., Lin, F., Li, M., et al.[2022]

In a study involving 143 myopic children over 12 months, repeated low-level red-light (RLRL) therapy led to significant increases in choroidal parameters, indicating potential benefits for myopia control.

While the RLRL group showed thickening of the choroid and increases in both luminal and stromal areas, the control group experienced reductions in these parameters, suggesting that RLRL therapy may effectively counteract myopia progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal Changes in Choroidal Structure Following Repeated Low-Level Red-Light Therapy for Myopia Control: Secondary Analysis of a Randomized Controlled Trial. Xuan, M., Zhu, Z., Jiang, Y., et al.[2023]

In a study involving 264 children aged 8 to 13, repeated low-level red-light therapy (RLRL) significantly reduced axial elongation and spherical equivalent refraction progression compared to standard single-vision spectacles, suggesting it is effective for myopia control.

The RLRL therapy was safe, with no severe adverse events or functional visual loss reported, indicating it could be a promising alternative treatment for managing myopia in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Repeated Low-Level Red-Light Therapy for Myopia Control in Children: A Multicenter Randomized Controlled Trial. Jiang, Y., Zhu, Z., Tan, X., et al.[2022]

Repeated low-intensity red light (RLRL) treatment may effectively delay the progression of childhood myopia, with significant reductions in spherical equivalent refractive error and axial length observed in a meta-analysis of 13 studies involving 1857 children and adolescents.

The evidence supporting RLRL therapy is of low certainty, indicating a need for larger, well-designed randomized clinical trials with longer follow-up periods to better inform medical guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Repeated Low-Level Red-Light Therapy for Slowing the Progression of Childhood Myopia: A Systematic Review and Meta-analysis. Tang, J., Liao, Y., Yan, N., et al.[2023]

In a study of 47 myopic children receiving repeated low-level red-light therapy (RLRLT) for 4 weeks, there was a significant increase in subfoveal choroidal thickness, suggesting improved choroidal blood perfusion compared to a control group.

RLRLT did not cause any abnormal retinal morphology or photodamage, indicating that this treatment is safe for enhancing blood flow in the eyes of myopic children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of red-light therapy on retinal and choroidal blood perfusion in myopic children. Zhao, C., Ni, Y., Zeng, J.[2023]

Continued low-level red-light (RLRL) therapy over 2 years significantly slowed myopia progression in children, with the RLRL-RLRL group showing the least axial elongation and spherical equivalence refraction changes.

No adverse effects were reported during the study, indicating that RLRL therapy is safe for long-term use, although a modest rebound effect in myopia progression was observed after treatment cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained and rebound effect of repeated low-level red-light therapy on myopia control: A 2-year post-trial follow-up study. Xiong, R., Zhu, Z., Jiang, Y., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Myopia Control Effect of Repeated Low-Level Red-Light Therapy in Chinese Children: A Randomized, Double-Blind, Controlled Clinical Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Repeated Low-Level Red Light Therapy for the Control of Myopia in Children: A Meta-Analysis of Randomized Controlled Trials. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy Comparison of Repeated Low-Level Red Light and Low-Dose Atropine for Myopia Control: A Randomized Controlled Trial. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Immediate effect in retina and choroid after 650 nm low-level red light therapy in children. [2022]

5. China pubmed.ncbi.nlm.nih.gov

Longitudinal Changes in Choroidal Structure Following Repeated Low-Level Red-Light Therapy for Myopia Control: Secondary Analysis of a Randomized Controlled Trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of Repeated Low-Level Red-Light Therapy for Myopia Control in Children: A Multicenter Randomized Controlled Trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Repeated Low-Level Red-Light Therapy for Slowing the Progression of Childhood Myopia: A Systematic Review and Meta-analysis. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Effect of red-light therapy on retinal and choroidal blood perfusion in myopic children. [2023]

9. Australia pubmed.ncbi.nlm.nih.gov

Sustained and rebound effect of repeated low-level red-light therapy on myopia control: A 2-year post-trial follow-up study. [2023]