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NCT05597397
Effect of Repeated Low-Level Red-Light Therapy on Retinal Function and Structure
Conditions: Myopia, Refractive Errors, Eye Diseases, Retina; Change
Sex: All
Ages: 15 Years – 16 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 40
Sponsor: Shanghai Eye Disease Prevention and Treatment Center
Location: China
Summary
The purpose of this clinical trial is to evaluate the effect of repeated low-level red-light (RLRL) therapy on the retinal function and structure among myopic teenagers.
Eligibility Criteria
Inclusion Criteria:Age: 15-16 years at enrolment.Myopia: cycloplegic spherical equivalent refractions (SERs) range from -1.00 to -5.00 diopters (D) and astigmatism less than -2.5 D in either eye.Best corrected visual acuity equal to or better than 0.8 in either eye.Normal fundus, or tessellated fundus.Provision of consent and able to participate in all required activities of the study.Exclusion Criteria:Secondary myopia, such as a history of retinopathy of prematurity or neonatal problems, or syndromic myopia with a known genetic disease or connective tissue disorders, such as Stickler or Marfan syndrome.Strabismus and binocular vision abnormalities in either eye.Refractive media opacity: corneal opacities, cataract, or implanted intraocular lens, etc.Ocular abnormalities that affect retinal function: macular degeneration, diabetic retinopathy, retinal detachment, glaucoma, or ocular hypertension, endophthalmitis, uveitis, optic neuropathy, etc.Previous history of refractive surgery, intraocular surgery, laser therapy, and intravitreal injection, etc.Systemic abnormalities: diabetes, hypertension, etc.Drugs therapies with toxicity effect on the retina: hydroxychloroquine, etc.Prior treatment of myopia control in the past three months, drugs, orthokeratology, progressive addition lenses, bifocal lens, etc.Other contraindications, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.
Source: ClinicalTrials.gov (NCT05597397). StuddyBuddy aggregates publicly available trial information.