What side effects are associated with this type of intervention?

Common treatments for near-sightedness include low-level red light therapy, atropine eye drops, and violet light exposure. Low-level red light therapy has been shown to slow myopia progression without significant adverse events. Atropine eye drops, used in various concentrations, can cause side effects such as photophobia (light sensitivity) and difficulty with near vision. Violet light exposure is being studied for its potential to suppress myopia, but specific side effects are not well-documented yet. Overall, these treatments are generally well-tolerated, but patients should discuss potential risks with their healthcare provider.

What prior FDA approvals exist?

Currently, there are no FDA-approved drugs specifically for the treatment of near-sightedness (myopia). Traditional treatments for myopia include corrective lenses (glasses or contact lenses) and refractive surgery (such as LASIK). The study on violet light for the suppression of myopia is exploring a novel approach, but as of now, no similar treatments have received FDA approval.

What other types of research exist?

Promising alternatives to violet light for treating near-sightedness in 2024 include: 1) Atropine eye drops, which have been shown to slow myopia progression. 2) Orthokeratology (Ortho-K) lenses, which temporarily reshape the cornea to reduce myopia. 3) Increased outdoor activities, as exposure to natural light has been associated with reduced myopia progression. 4) Managing near work by increasing working distance and taking regular breaks to reduce eye strain.

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Procedure

Violet Light Therapy for Near-Sightedness

Q: What is the mechanism of action of this treatment?

The most common treatments for Near-sightedness include corrective lenses (glasses or contact lenses), orthokeratology (specialized contact lenses worn overnight to reshape the cornea), and refractive surgery (such as LASIK). Corrective lenses work by adjusting the focal point of light entering the eye, allowing it to focus correctly on the retina. Orthokeratology temporarily reshapes the cornea to improve vision during the day. Refractive surgery permanently changes the shape of the cornea to correct the focal point. These treatments are crucial for Near-sightedness patients as they improve visual acuity and reduce the strain on the eyes. The study on violet light suggests that exposure to specific wavelengths of light may influence eye growth and development, potentially offering a non-invasive method to control or reduce the progression of myopia.

N/A

Recruiting

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children must be between 5 to <13 years old

Diagnosis of Myopia (ICD-10-CM Diagnosis Code H52.13) with refractive error:

Must not have

Abnormality of cornea, lens, central retina, iris, or ciliary body

Current or prior history of manifest strabismus, amblyopia, or nystagmus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at baseline, and 12 months.

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly stated, potential side effects may include discomfort due to bright light exposure, headache, eye strain or sleep disturbances due to changes in lighting environment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child is between 5 and 12 years old.

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I have been diagnosed with Myopia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have or had crossed eyes, lazy eye, or involuntary eye movement.

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I have had surgery on my eyelid, for eye muscle issues, inside my eye, or to correct my vision.

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I have been treated for nearsightedness with specific eye drops.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline, and 12 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at baseline, and 12 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline, and 12 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Axial Length

Refractive Error

Visual Acuity

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Violet + / Lens -Experimental Treatment1 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 Treatment1 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 Group1 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 +).

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Near-sightedness include corrective lenses (glasses or contact lenses), orthokeratology (specialized contact lenses worn overnight to reshape the cornea), and refractive surgery (such as LASIK). Corrective lenses work by adjusting the focal point of light entering the eye, allowing it to focus correctly on the retina. Orthokeratology temporarily reshapes the cornea to improve vision during the day. Refractive surgery permanently changes the shape of the cornea to correct the focal point. These treatments are crucial for Near-sightedness patients as they improve visual acuity and reduce the strain on the eyes. The study on violet light suggests that exposure to specific wavelengths of light may influence eye growth and development, potentially offering a non-invasive method to control or reduce the progression of myopia.

Clinical predictors of the optimal spectacle correction for comfort performing desktop tasks.Tinted lenses and related therapies for learning disabilities--a review.Assessing Photoreceptor Status in Retinal Dystrophies: From High-Resolution Imaging to Functional Vision.