Clinical trial NCT05606237: Efficacy of Repeated Low-level Red-light Therapy in Myopia Control
Official title: Efficacy of Repeated Low-level Red-light Therapy in Myopia Control: a Single Arm Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Keywords: myopia
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Melbourne
First posted: 2022-11-04
Enrollment: 90
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This trial is a single-center, multi-ethnic, single-blind, single arm controlled trial designed to evaluate the efficacy and safety of low level red light treatment on myopia among multi-ethnic schoolchildren.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

1. Provision of consent
2. Non-Chinese Ethnicity
3. Age: ≥8 and ≤13 years at enrollment
4. 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 study6) Corrected monocular logMAR visual acuity (VA): 1.0 or better

Exclusion Criteria:

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. Other reasons, including but not limited to severe physical and cognitive disability, that the physician may consider inappropriate for enrollment
4. Noncompliance with treatment
5. Children whose parents do not sign informed consent

Primary outcomes:
measure: Axial Length (AL) (mm) at Baseline
timeFrame: 1 month
measure: Axial Length (AL) (mm) at Month 1
timeFrame: 1 month
measure: Axial Length (AL) (mm) at Month 3
timeFrame: 3 months
measure: Axial Length (AL) (mm) at Month 6
timeFrame: 6 months
measure: Axial Length (AL) (mm) at Year 1
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jonathan Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.