Device Safety
1.RLRL SAFETY
The MCT Myopia Treatment Device employs a 650 nm wavelength low-intensity semiconductor laser, classified as a safe and effective method for managing myopia in children and adolescents.
Key safety features include:
Low Power Output:
The device operates at 1 mW power at a distance of 10 cm from the light source, with an illuminance of 730 Lux.
This output level is significantly below thresholds that could cause photothermal damage, aligning with Class 1 light safety standards established by the International Electrotechnical Commission (IEC 60825-1:2014).
Natural Light Mimicry:
The emitted red light simulates a natural component of sunlight, supporting the physiological processes associated with healthy eye development.
Clinical Validation of Safety:
Across multiple clinical studies, no cases of structural damage, light-induced retinal abnormalities, or adverse events such as photophobia were observed.
OCT imaging consistently confirmed the absence of tissue damage, even in long-term use over 12 months.
Mechanism of Action:
The device enhances retinal dopamine production, a light-dependent neurotransmitter that regulates ocular growth and prevents abnormal elongation of the eye axis.
This mechanism directly supports myopia control while preserving the structural and functional integrity of the eye.
Usage Protocol for Safety Assurance:
Designed for twice-daily use, with each session lasting 3 minutes and a minimum interval of 4 hours. This controlled exposure ensures effective treatment while mitigating risks associated with prolonged or excessive light exposure.
2.Clinical Evidence:
The study, published in the American Academy of Ophthalmology journal (2024), provides comprehensive evidence on the safety and efficacy of Repeated Low-Level Red Light (RLRL) Therapy in managing myopia progression in children and adolescents with high myopia.
Study Overview
Design: Multicenter, randomized, parallel-group, single-blind clinical trial (NCT05184621).
Participants: 192 children aged 6–16 years with at least one eye having high myopia (cycloplegic spherical equivalent refraction ≤ -4.0 diopters) and best-corrected visual acuity ≥ 20/25.
Duration: February 2021 to April 2023 (12-month follow-up).
Intervention: Participants were randomly assigned to either RLRL treatment (using a 650 nm portable device, twice daily for 3 minutes, 7 days a week) combined with single-vision spectacles or to a control group using only single-vision spectacles.
Key Findings
Efficacy：
Axial Length (AL):
The intervention group experienced a mean AL change of -0.06 mm (95% CI: -0.10 to -0.02 mm), indicating axial shortening.
In contrast, the control group showed a mean AL elongation of 0.34 mm (95% CI: 0.30 to 0.39 mm).
Notably, 53.3% of participants in the RLRL group exhibited significant axial shortening (>0.05 mm) after 12 months.
Spherical Equivalent Refraction (SER):
The mean SER change in the RLRL group was +0.11 diopters (D) (95% CI: +0.02 to +0.19 D), compared to -0.75 D (95% CI: -0.88 to -0.62 D) in the control group.
Safety:
Comprehensive macular OCT scans revealed no retinal or choroidal structural abnormalities in either group.No adverse events such as vision loss, glare, flickering, or prolonged afterimages were reported.
One case of conjunctivitis was recorded in the intervention group, unrelated to device use.
Compliance
The median compliance rate for RLRL therapy was 84%, with reminders and real-time tracking ensuring adherence.
3.Regulatory Approvals
The device meets the quality, safety, and efficacy standards required by medical regulators in Europe: CE mark, Class IIa.
If you seeking more information on our availability in your country, please contact lijiahao@mctlens.com
