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Active Not Recruiting NCT05606237

Efficacy of Repeated Low-level Red-light Therapy in Myopia Control

Conditions: Myopia

Sex: All
Ages: 8 Years – 13 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 90
Sponsor: University of California, San Francisco

Location: United States

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.

Eligibility Criteria

Inclusion Criteria:Provision of consentAge: ≥8 and ≤13 years at enrollmentMyopia: Spherical equivalent refractions (SERs) under cycloplegia: -1.00 to -5.00 diopters (D)Astigmatism of 2.50 D or lessAnisometropia of 1.50 D or lessCorrected monocular logMAR visual acuity (VA): 1.0 or betterConsent to participate in random allocation of groupingFluent in EnglishWilling and able to participate in all required activities of the studyRace/ethnicity is either African, Hispanic, or Caucasian.Exclusion Criteria:Strabismus and binocular vision abnormalities in either eyeOcular abnormalities in either eye or other systemic abnormalities that affect participate in all required activities of the study.Prior treatment of myopia control in either eye, including but not limited to drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc.Other reasons, including but not limited to severe physical and cognitive disability, that the physician may consider inappropriate for enrollmentNoncompliance with treatmentChildren whose parents do not sign informed consent

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05606237). StuddyBuddy aggregates publicly available trial information.