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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05606237
• Other study ID #: 21-35793
• Status: Recruiting
• Phase: N/A
• Start date: July 14, 2023
• Est. completion date: July 14, 2025

Study information

• Verified date: June 2024
• Source: University of California, San Francisco
• Contact: Julius Oatts, MD
• Phone: (415) 353-2800
• Email: julius.oatts[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 14, 2025
• Est. primary completion date: July 14, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

Inclusion Criteria:

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.

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. 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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Low-level Red Light Therapy Device
The treatment device used in this study is a semi-conductor laser product (Eyerising International Pty Ltd, Melbourne, Australia), emitting low-level red-light with a wavelength of 650 ± 10 nm. Based on calculations done by the manufacturer, the device provides light at a power of 2.00 ± 0.50 mW.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	University of Melbourne

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial Length (AL) (mm) at Baseline	Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.	1 month
Primary	Axial Length (AL) (mm) at Month 1	Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.	1 month
Primary	Axial Length (AL) (mm) at Month 3	Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.	3 months
Primary	Axial Length (AL) (mm) at Month 6	Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.	6 months
Primary	Axial Length (AL) (mm) at Year 1	Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.	1 Year