Last updated: January 9, 2024
Sponsor: Children's Hospital Medical Center, Cincinnati
Overall Status: Active - Recruiting
Phase
N/A
Condition
Myopia
Treatment
Violet Light Lamp
BIOS Skyview Lamp
Aooshine Bedside Lamp
Clinical Study ID
NCT06110520
2021-0289
Ages 5-12 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Children must be between 5 to <13 years old.
- Diagnosis of Myopia (ICD-10-CM Diagnosis Code H52.13) with refractive error:
- Myopia -1.00D to -6.00D spherical equivalent (SE) in both eyes
- Astigmatism <=1.50D in both eyes
- Anisometropia <=1.00D SE • Relocation outside of the CCHMC area within the next 12months is not anticipated.
Exclusion
Exclusion Criteria: Current or previous myopia treatment with atropine, pirenzepine, or other antimuscarinicagents
- Current or previous use of bifocals, progressive addition lenses, or multi-focalcontact lenses
- Current or previous use of orthoK, rigid gas permeable, or other contact lenses beingused to reduce myopia progression
- Current or prior history of manifest strabismus, amblyopia, or nystagmus
- Abnormality of cornea, lens, central retina, iris, or ciliary body
- Prior eyelid, strabismus, intraocular, or refractive surgery
- Down syndrome or cerebral palsy
Study Design
Total Participants: 72
Treatment Group(s): 4
Primary Treatment: Violet Light Lamp
Phase:
Study Start date:
June 07, 2023
Estimated Completion Date:
March 01, 2026
Study Description
Connect with a study center
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45209
United StatesActive - Recruiting
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