Violet Light Therapy for Near-Sightedness

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Children's Hospital Medical Center, Cincinnati

Must not be taking: Antimuscarinics

Disqualifiers: Strabismus, Amblyopia, Nystagmus, others

Trial Summary

What is the purpose of this trial?

This trial uses special violet light lamps to see if they can help slow down the worsening of nearsightedness in children. The study compares these lamps to regular white light lamps, focusing on their effects over time.

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 data supports the effectiveness of the treatment Violet Light Therapy for Near-Sightedness?

The study on lighting interventions for individuals with low vision showed improvements in visual functioning and quality of life, suggesting that light-based treatments can be beneficial for vision-related issues. ^{1 2 3 4 5}

Is violet light therapy safe for humans?

Research on bright light therapy, which includes similar treatments, suggests that while it is generally safe, there can be minor side effects like blurring. It's important to use lamps that don't emit harmful light and to have regular eye check-ups, especially for those with existing eye conditions. ^{2 6 7 8 9}

How is Violet Light Therapy for Near-Sightedness different from other treatments?

Violet Light Therapy using the Aooshine Bedside Lamp and BIOS Skyview Lamp is unique because it involves using specific light exposure to potentially improve vision, unlike traditional treatments that may rely on glasses, contact lenses, or surgery. This approach is similar to syntonic phototherapy, which uses light to address visual anomalies, but its effectiveness for near-sightedness is not yet well-established. ^{1 2 4 10 11}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Aooshine Bedside Lamp (Procedure)
• BIOS Skyview Lamp (Procedure)

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.

Participant Groups

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+

Steve Davis

Children's Hospital Medical Center, Cincinnati

Chief Executive Officer since 2021

MD

Daniel Ostlie

Children's Hospital Medical Center, Cincinnati

Chief Medical Officer

MD from University of North Dakota

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

References

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

Photometric and Colorimetric Evaluation of Phototherapy Instruments for Syntonic Treatment of Visual Anomalies. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Therapist-assisted vision therapy improves outcome for stroke patients with homonymous hemianopia alone or combined with oculomotor dysfunction. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Health-related quality of life following blind rehabilitation. [2021]

4. Spain pubmed.ncbi.nlm.nih.gov

[First results of the IOBA low vision unit]. [2006]

5. England pubmed.ncbi.nlm.nih.gov

Impact of Lighting Assessment and Optimization on Participation and Quality of Life in Individuals with Vision Loss. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Bright light therapy in focus: lamp emission spectra and ocular safety. [2007]

7. England pubmed.ncbi.nlm.nih.gov

Paranoid delusions and hallucinations and bright light therapy in Alzheimer's disease. [2022]

8. Spain pubmed.ncbi.nlm.nih.gov

[Positive effect of bright light therapy on mood and sleep quality in institutionalized older people]. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Bright light therapy: Minimizing light induced side effects with an innovative light setup. [2014]

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

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

11. England pubmed.ncbi.nlm.nih.gov

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