Clinical trial NCT05761379: Clinical Study of Light Therapy to Control Myopia Progression in Children
Official title: Clinical Study of Low Lever Red Light Therapy With 650nm to Control Myopia Progression in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia, Progressive
Lead sponsor: Beijing Airdoc Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Eye & ENT Hospital of Fudan University
First posted: 2023-03-09
Enrollment: 83
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Low lever red light therapy with Model : Sky-n1201c at the wavelength of 650nm; 3 minutes illumination for both eyes, administered twice daily at the interview of 4 hours.

Children in the red light therapy group wore single vision spectacles the entire day and under red light therapy (power, 0.6mW; wavelength, 650nm; Beijing Airdoc MPC Co. Ltd, Beijing, China) twice per day for 3 minutes each session, with at least a 4-hour interval between sessions. There were no specific guidelines for room illumination. After the first measurement session, each child returned for follow-up examinations at 1, 3, and 6 months and completed all the aforementioned examinations.
Primary purpose: TREATMENT

Brief summary: Low-lever red light therapy (LLLT) has been used to control myopia progression in China for a few years besides amblyopia therapy for a few decades. This study is to test the efficacy of PBM therapy to myopia children as well as to compare two types of PBM therapy to control myopia progression within one month.

Detailed description: LLLT utilized the 650-nm red light to provide sufficient energy to stimulate the tissue without causing damage to the surrounding tissues. And several researchers reported the long-term efficacy of LLLT in slowing the progression of myopia to date. These studies were reported various illumination and irradiance. This study is to test the efficacy of LLLT comparing to the control group as well as to test whether two types of lighting design will be different to the efficacy and safety.

Eligibility criteria: Inclusion Criteria:

1. Grade 1 to grade 9 and age 6 to 16 years (including 6 and 16 years), Sex is not limited;
2. Equivalent sphere (SER): -0.50D \~ -6.00D (including-0.50 and-6.00D);
3. Best corrected vision in one eye under glasses correction: 0.1 log MAR;
4. No strabismus: no more than 15 prism constant dominance strabismus after far and near cover tests;
5. No myopia control measures within the previous 4 weeks: such as orthokeratology lens, gradient lens, double light lens, eye drops for myopia control (such as atropine), myopia defocus glasses, red light for myopia control, other specially designed myopia light treatment instruments or contact lenses for special design to control myopia (such as Misight);

Exclusion Criteria:

1. Any ocular(including constant dominant strabismus with more than 15 prisms) and systemic diseases or abnormalities can significantly affect visual function or promote the progression of myopia;
2. Other interventions for myopia control before 4 weeks before enrollment, For example, orthoplastic lens, gradient lens, dual-light lens, eye drops for myopia control (atropine), myopia defocus glasses, red light therapy devices for myopia control, other specially designed comprehensive treatment devices, myopia, amblyopia, or specially designed contact lenses (such as Misight), etc.
3. Subject participated in other clinical trials within 4 weeks before the enrollment;
4. The investigator for safety reasons or the interests of the patient, Other circumstances in which the patient should not participate in this trial, If suffering from serious heart, liver and kidney disease. -

Primary outcomes:
measure: Changes in axial length (mm）
timeFrame: at 1-month Follow-up
Secondary outcomes:
measure: Changes in cycloplegic autorefraction (diopters, D)
timeFrame: at 1-month Follow-up and at baseline
measure: Changes of choroidal thickness under macular foveal (um)
timeFrame: at 1-month Follow-up and at baseline
measure: Changes of cornea power
timeFrame: at 1-month Follow-up and at baseline
measure: Change in retina fovea perfusion density (RFPD, %)
timeFrame: at 1-month Follow-up and at baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye & ENT hospital of Fudan university
state: Shanghai
Study officials:
affiliation: Eye & ENT Hospital of Fudan University
name: Xingtao Zhou, M.D. PhD.
role: STUDY_CHAIR
affiliation: Eye & ENT Hospital of Fudan University
name: Weicun Chen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Eye & ENT Hospital of Fudan University
name: Meiyan Li, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Yang W, Lin F, Li M, Wei R, Zhou J, Zhou X. Immediate Effect in the Retina and Choroid after 650 nm Low-Level Red Light Therapy in Children. Ophthalmic Res. 2023;66(1):312-318. doi: 10.1159/000527787. Epub 2022 Oct 31.
citation: Liu G, Li B, Rong H, Du B, Wang B, Hu J, Zhang B, Wei R. Axial Length Shortening and Choroid Thickening in Myopic Adults Treated with Repeated Low-Level Red Light. J Clin Med. 2022 Dec 17;11(24):7498. doi: 10.3390/jcm11247498.