Summary

Eligibility
for people ages 8-13 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Julius Oatts, MD
Headshot of Julius Oatts
Julius Oatts

Description

Summary

Low-level red-light technology provides a new and innovative myopia control approach. This strategy enables relatively high energies of light to be delivered at much shorter durations of exposure to induce the myopia control effect. The efficacy of the low-level red-light technology has been proven in a Chinese population. This trial demonstrated that 3-minutes per session twice a day repeated low-level red-light treatment controlled 87.7% of refraction progression and 76.8% of axial length elongation when the time of compliance to the treatment was 75%. Repeating this RCT in culturally diverse groups will confirm and translate this technology into a solution for myopia control globally.

Official Title

Efficacy of Repeated Low-level Red-light Therapy in Myopia Control: a Randomized Controlled Trial

Details

The purpose of this study is to assess the safety and efficacy of low level red light therapy in myopia control in African, Hispanic, and Caucasian children. This is a prospective, multi-ethnic, parallel-controlled randomized trial that will enroll myopic children aged 8-13 years old as subjects. On top of wearing single vision spectacles, subjects in the intervention group will receive treatment twice a day from Monday to Friday, with each treatment lasting for 3 minutes at a minimal interval of 4 hours. Subjects in the control group will wear single vision spectacles. The study will evaluate axial elongation, cycloplegic spherical equivalent change, changes in other biological parameters (except axial length), and uncorrected and best corrected visual acuity of the two groups of subjects at 1 month, 3 months, 6 months, and 12 months after enrollment. The study plans to conduct an interim analysis at a three-month follow-up. The enrollment target is 90 participants: 30 Hispanic Children (15 control and 15 treatment) , 30 African Children (15 control and 15 treatment), and 30 Caucasian Children (15 control and 15 treatment).

Keywords

Myopia, Low-level Red Light Therapy Device

Eligibility

You can join if…

Open to people ages 8-13

  1. Provision of consent
  2. Age: ≥8 and ≤13 years at enrollment
  3. Myopia: Spherical equivalent refractions (SERs) under cycloplegia: -1.00 to -5.00 diopters (D)
  4. Astigmatism of 2.50 D or less
  5. Anisometropia of 1.50 D or less
  6. Corrected monocular logMAR visual acuity (VA): 1.0 or better
  7. Consent to participate in random allocation of grouping
  8. Fluent in English
  9. Willing and able to participate in all required activities of the study
  10. . Race/ethnicity is either African, Hispanic, or Caucasian.

You CAN'T join if...

  1. Strabismus and binocular vision abnormalities in either eye
  2. Ocular abnormalities in either eye or other systemic abnormalities that affect participate in all required activities of the study.
  3. Prior treatment of myopia control in either eye, including but not limited to drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc.
  4. Other reasons, including but not limited to severe physical and cognitive disability, that the physician may consider inappropriate for enrollment
  5. Noncompliance with treatment
  6. Children whose parents do not sign informed consent

Location

  • University of California, San Francisco
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Julius Oatts, MD
    Dr. Julius Oatts is a pediatric ophthalmologist and a pediatric glaucoma specialist who specializes in the medical and surgical treatment of children with common eye diseases as well as glaucoma, a rare condition in children. His research focuses on the most accurate ways to measure eye pressure in children.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05606237
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated