Violet Light Therapy for Near-Sightedness

Overseen By Kat Castleberry, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Must not be taking: Antimuscarinics

Disqualifiers: Strabismus, Amblyopia, Nystagmus, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether violet light can slow the progression of near-sightedness (myopia) in children. It uses special bedside lamps, such as the Aooshine Bedside Lamp, that emit violet light, along with lenses that either block or allow this light. Participants are children aged 5 to 12 diagnosed with myopia who have not used treatments like bifocals or orthoK lenses. The study aims to determine if violet light exposure can impact myopia management. As an unphased trial, it offers a unique opportunity for children to potentially benefit from innovative myopia management strategies.

Will I have to stop taking my current medications?

The trial requires that participants have not used certain myopia treatments like atropine, pirenzepine, or other similar medications. If you are currently using these, you would need to stop before joining the trial.

What prior data suggests that these lamps are safe for use in this study?

Research has shown that the Aooshine Bedside Lamp and BIOS SkyView Lamp have undergone safety testing. These lamps emit violet light, which researchers are studying to determine if it can slow the progression of myopia (near-sightedness). Underwriter Laboratories, a well-known safety organization, has completed safety testing on these lamps, confirming their safe use as intended.

The BIOS SkyView Lamp, developed by NASA engineers, also aids focus, mood, and sleep, suggesting its safety for everyday use. Although these tests do not specifically address potential side effects from violet light, the general safety of these lamps in other applications is reassuring.

Based on current information, both lamps appear safe for use in this study. More specific safety details related to the study's goals may become available as research progresses. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the potential of violet light therapy as a treatment for near-sightedness because it offers a new, non-invasive approach. Traditional treatments for near-sightedness typically include glasses, contact lenses, and sometimes surgical interventions like LASIK. Unlike these options, violet light therapy uses a specific spectrum of light to potentially slow or alter the progression of near-sightedness. The treatments being explored involve using lamps that emit violet light, either with lenses that block or allow the transmission of this light, offering a unique mechanism of action compared to simply correcting vision with lenses. This innovative approach could provide a complementary option that targets the biological underpinnings of near-sightedness rather than just correcting the eyesight.

What evidence suggests that this trial's treatments could be effective for suppressing myopia?

Research suggests that violet light might help slow the progression of myopia (nearsightedness). In this trial, participants will join different treatment arms to assess the effects of violet light. Some participants will use the Aooshine Bedside Lamp, which emits violet light and has shown potential in improving eyesight. Others will use the BIOS Skyview Lamp, which uses a special light mix to mimic natural sunlight and may also benefit eye health. Both lamps are designed to be safe and easy to use, with the Aooshine noted for its effectiveness in similar contexts. These early findings offer promise for those seeking non-invasive ways to manage myopia. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for children aged 5 to less than 13 with near-sightedness (myopia) between -1.00D and -6.00D, and astigmatism up to 1.50D in both eyes. They shouldn't have a history of certain eye treatments or conditions like abnormal cornea or myopia treatment with specific drugs, nor plans to move out of the CCHMC area within a year.

Inclusion Criteria

Your astigmatism is not greater than 1.50D in both eyes.

My child is between 5 and 12 years old.

Your myopia is in the range of -1.00D to -6.00D spherical equivalent (SE) for both eyes.

Exclusion Criteria

You have Down syndrome or cerebral palsy.

I have an eye condition affecting my cornea, lens, retina, iris, or ciliary body.

You are currently using or have used special contact lenses to slow down the progression of nearsightedness.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use violet light-emitting lamps with different lens combinations to assess the suppression of myopia

12 months

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aooshine Bedside Lamp
• BIOS Skyview Lamp

Trial Overview The study tests whether violet light from two different lamps (Aooshine Bedside Lamp and BIOS Skyview Lamp) can help control the worsening of near-sightedness in children by comparing their effects on myopia progression.

How Is the Trial Designed?

Group I: Violet + / Lens - Experimental Treatment 1 Intervention

Subjects use a violet light emitting lamp (device intervention - minimally invasive as it's simply a source of light) with polycarbonate lenses for their refractive correction. The lamp introduces violet light (Violet +) while the polycarbonate lenses block the transmission of violet light through the lenses (Lens -).

Group II: Violet + / Lens + Experimental Treatment 1 Intervention

Subjects use a violet light emitting lamp (device intervention - minimally invasive as it's simply a source of light) with CR-39 lenses for their refractive correction. The lamp introduces violet light (Violet +) and the CR-39 lenses allow for the transmission of violet light through the lenses (Lens +).

Group III: Violet - / Lens + Placebo Group 1 Intervention

Subjects use a lamp with NO violet light (Violet -) with CR-39 lenses for their refractive correction. CR-39 lenses allow for the transmission of violet light through the lenses (Lens +).

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Published Research Related to This Trial

A pilot study involving 60 participants with low vision showed that a holistic lighting intervention significantly improved their quality of life and visual functioning, as measured by various assessments including the Canadian Occupational Performance Measure (COPM).

Participants demonstrated notable improvements in specific visual tasks and overall performance after the intervention, indicating that tailored lighting solutions can effectively enhance daily activities for individuals with visual impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Lighting Assessment and Optimization on Participation and Quality of Life in Individuals with Vision Loss. Øien, TB., Jacobsen, AM., Tødten, ST., et al.[2023]

Residential blind rehabilitation significantly improves vision-targeted health-related quality of life (HRQOL) in legally blind veterans, with notable enhancements in nine out of eleven NEI VFQ subscales measured at 2 and 6 months post-rehabilitation.

Participants also reported improvements in mental health and self-esteem after rehabilitation, although physical health ratings declined over the study period, indicating a need for further support in that area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-related quality of life following blind rehabilitation. Kuyk, T., Liu, L., Elliott, JL., et al.[2021]

Therapist-assisted vision therapy over 12 weeks significantly improved visual performance in stroke patients, with 24 participants showing enhanced reading speed and peripheral awareness after training.

Patients reported feeling safer during outdoor activities and traffic, indicating that the therapy not only improved visual skills but also positively impacted their confidence and daily life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapist-assisted vision therapy improves outcome for stroke patients with homonymous hemianopia alone or combined with oculomotor dysfunction. Smaakjær, P., Tødten, ST., Rasmussen, RS.[2018]

Bright light therapy is effective for treating seasonal affective disorder (SAD) and has potential applications for other conditions like circadian sleep phase disorders and jet lag, but the safety of different light sources is a concern.

The study analyzed various light therapy fixtures, revealing that many emit unknown spectral emissions that could cause ocular damage, leading to recommendations for safer lamp choices and monitoring for patients undergoing prolonged treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light therapy in focus: lamp emission spectra and ocular safety. Remé, CE., Rol, P., Grothmann, K., et al.[2007]

The study analyzed four commonly used lamps in ocular light exposure therapy, revealing significant variability in their illuminance levels and spectral power distribution, which can affect treatment outcomes.

There is a need for more longitudinal research to evaluate the efficacy of syntonic phototherapy in optometric practices, as current studies lack consensus and are limited by the variability in lamp characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photometric and Colorimetric Evaluation of Phototherapy Instruments for Syntonic Treatment of Visual Anomalies. López de la Fuente, C., Sánchez-Cano, AI.[2023]

Bright light therapy (BLT) can be beneficial for some patients with Alzheimer's-type dementia, as it may help reduce delusions and agitation, but caution is necessary due to potential adverse effects.

In one case, an 80-year-old woman experienced increased agitation and developed delusional symptoms after 14 days of BLT, leading to the treatment's discontinuation, which resulted in the rapid resolution of her symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paranoid delusions and hallucinations and bright light therapy in Alzheimer's disease. Schindler, SD., Graf, A., Fischer, P., et al.[2022]

In a study involving 37 elderly individuals in a nursing home, bright light therapy (BLT) significantly improved sleep quality, mood, cognitive status, and overall quality of life after just three weeks of treatment.

The therapy involved exposure to bright light (7,000-10,000 lux) for a short period each morning, leading to measurable improvements in various health metrics, indicating its potential as an effective intervention for enhancing well-being in institutionalized older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Positive effect of bright light therapy on mood and sleep quality in institutionalized older people]. Rubiño-Díaz, JÁ., Nicolau-Llobera, C., Martin-Reina, A., et al.[2021]

In a study of 80 patients undergoing a customized vision rehabilitation program, 89% reported improvements in their quality of life, both functionally and psychologically.

The rehabilitation training led to 85% of patients improving in near vision activities and 35% in far vision activities, highlighting the effectiveness of specialized low vision care and training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[First results of the IOBA low vision unit]. Coco Martín, MB., Arranz De La Fuente, I., González García, MJ., et al.[2006]

Optometric vision therapy has been shown to be an effective treatment for both children and adults with nonstrabismic accommodative and vergence disorders, supported by objective studies that assess changes in oculomotor responsivity.

The therapy's efficacy aligns with principles of general motor learning, indicating that it not only helps improve vision but also enhances the underlying motor skills involved in eye movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The scientific basis for and efficacy of optometric vision therapy in nonstrabismic accommodative and vergence disorders. Ciuffreda, KJ.[2009]

For visually impaired children aged 0-3 years, the preferential looking procedure is the gold standard for measuring near visual acuity, with established norms for children aged 6-36 months.

For children aged 4-7 years, LEA symbols are recommended due to their validation for preliterate children, while for those aged 8-13 years, the ETDRS letter chart is preferred as it better predicts functional vision and reading ability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of near visual acuity in 0-13 year olds with normal and low vision: a systematic review. Huurneman, B., Boonstra, FN.[2022]

In a study involving 20 healthy participants, a new bright light therapy (BLT) cabin showed no reports of headaches, which are a common side effect of conventional BLT devices.

While some participants experienced blurring of vision (21.1% prevalence), the absence of headaches suggests that this new technology may improve patient adherence to treatment for seasonal depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light therapy: Minimizing light induced side effects with an innovative light setup. Leichtfried, V., Kantner-Rumplmair, W., Bartenbach, C., et al.[2014]

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/20/NCT06110520/Prot_000.pdf

Violet Light for the Treatment of Myopia Aooshine Bedside Lamps in slowing the progression of myopia ... Safety testing of both the BIOS SkyView lamp and the Aooshine Bedside Lamp was ...

2. myopiaprofile.com myopiaprofile.com/articles/low-dose-atropine-rebound-myopia-efficacy-safety

LAMP study Phase 4: early and continued treatment is key The LAMP phase 4 study found continuous treatment with 0.05% atropine over 5yrs was well-tolerated and effective in reducing myopia progression.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30514630/

Low-Concentration Atropine for Myopia Progression ... Conclusions: The 0.05%, 0.025%, and 0.01% atropine eye drops reduced myopia progression along a concentration-dependent response. All concentrations were well ...

4. bostoneyeblink.com bostoneyeblink.com/tag/myopia/

myopia – Boston Eye Blink A few years ago, Chinese ophthalmologists and researchers started using this device to slow myopia progression, and found it to be very effective. For example, ...

5. reviewofoptometry.com reviewofoptometry.com/article/lamp-study-atropine-005-effective-for-myopia-control-at-five-years

LAMP Study: Atropine 0.05% Effective For Myopia Control ... At five years, the data showed that continued 0.05% atropine treatment demonstrated good efficacy for myopia control.

6. amazon.com amazon.com/Bedside-Aooshine-Minimalist-Bedroom-Bookcase/dp/B074XPNS3Z

Bedside Lamps for Nightstand, Minimalist Night Stand ... ✪CHOICE FOR BETTER LIFE-The Cord, Socket and Plug of Aooshine bedside table lamp are UL listed. By giving products the listed, you don't have to worry about ...

7. ebay.com ebay.com/itm/286476785221

new Bedside Table Lamp, Aooshine Minimalist Solid ... Add a touch of minimalist elegance to your living space with the Aooshine Solid Wood Table Lamp. Crafted from premium wood with a subtle beige hue, this lamp is ...

8. amazon.com amazon.com/stores/Aooshine/NewArrivals/page/12710D19-C76E-43FB-9742-36612325748D

Aooshine: New Arrivals Bedside Lamp for Bedroom with USB Ports - Grey Table Lamp with USB C + A Charging Ports for Nightstand, Small Desk Light for Boys, Bulb Not Included.

9. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06110520/violet-light-for-the-suppression-of-myopia

Violet Light for the Suppression of Myopia The study uses violet light-emitting lamps as the variable and regular, white light lamps as the control in assessing whether violet light, ...