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Procedure

Violet Light Therapy for Near-Sightedness

Q: Do I fulfill the prerequisites to participate in this experiment?

The requirements for this trial involve being myopic and within the age range of 5 to 12. 72 participants are needed in total.

Q: Are there any age limitations to participation in this research trial?

This clinical trial is accepting participants aged between 5 and 12 years old.

Q: How many individuals are currently receiving treatment as part of this clinical experiment?

Indeed, the information on clinicaltrials.gov verifies that this trial is actively recruiting patients at present. It was initially posted on June 7th 2023 and updated lastly on October 25th 2023 with a target of 72 participants across 1 centre.

Q: Are there currently any opportunities to join this trial?

Affirmative. According to the data from clinicaltrials.gov, this research protocol is currently open for enrolment and was first posted on June 7th 2023. The study requirements have recently been amended on October 25th 2023, with a total of 72 participants being sought at one location.

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:

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at baseline, and 12 months.

Awards & highlights

Study Summary

This trial investigates how exposure to violet light might reduce the risk of nearsightedness.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,519 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I fulfill the prerequisites to participate in this experiment?

"The requirements for this trial involve being myopic and within the age range of 5 to 12. 72 participants are needed in total."

Answered by AI

Are there any age limitations to participation in this research trial?

"This clinical trial is accepting participants aged between 5 and 12 years old."

Answered by AI

How many individuals are currently receiving treatment as part of this clinical experiment?

"Indeed, the information on clinicaltrials.gov verifies that this trial is actively recruiting patients at present. It was initially posted on June 7th 2023 and updated lastly on October 25th 2023 with a target of 72 participants across 1 centre."

Answered by AI

Are there currently any opportunities to join this trial?

"Affirmative. According to the data from clinicaltrials.gov, this research protocol is currently open for enrolment and was first posted on June 7th 2023. The study requirements have recently been amended on October 25th 2023, with a total of 72 participants being sought at one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Violet Light for the Suppression of Myopia

2023. "Violet Light for the Suppression of Myopia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06110520.

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