Clinical Study of Light Therapy to Control Myopia Progression in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-28

Study Completion Date

2024-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myopia, Progressive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PBM therapy 1

PBM therapy was performed with a low-intensity laser (Airdoc, MPC Co.,Ltd., Beijing, China) with an irradiance of 0.6±0.2 mW, a wavelength of 650 nm±10 nm, and illumination of approximately 400 lux on average. The lighting spot for therapy is a dot. Only one eye will be treated with PBM therapy.

Group Type EXPERIMENTAL

Photobiomodualtion Therapy

Intervention Type DEVICE

low lever light therapy with laser semi-conductor at wavelength of 650nm

Single vision spectacles for correction myopia

Intervention Type DEVICE

Provide the distance best corrected vision acuity of refractive error of myopia for all the groups

PBM therapy 2

PBM therapy was performed with a low-intensity laser (Airdoc, MPC Co.,Ltd., Beijing, China) with an irradiance of 0.3±0.2 mW, a wavelength of 650 nm±10 nm, and illumination of approximately 400 lux on average. Only one eye will be treated with PBM therapy.

Group Type EXPERIMENTAL

Photobiomodualtion Therapy

Intervention Type DEVICE

low lever light therapy with laser semi-conductor at wavelength of 650nm

Single vision spectacles for correction myopia

Intervention Type DEVICE

Provide the distance best corrected vision acuity of refractive error of myopia for all the groups

Control

Single vision spectacles correction only.

Group Type PLACEBO_COMPARATOR

Single vision spectacles for correction myopia

Intervention Type DEVICE

Provide the distance best corrected vision acuity of refractive error of myopia for all the groups

Interventions

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Photobiomodualtion Therapy

low lever light therapy with laser semi-conductor at wavelength of 650nm

Intervention Type DEVICE

Single vision spectacles for correction myopia

Provide the distance best corrected vision acuity of refractive error of myopia for all the groups

Intervention Type DEVICE

Other Intervention Names

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Myopia light therapy; Low lever light therapy; Low lever laser therapy; Low intensity red light thearpy Glasseses

Eligibility Criteria

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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. -

Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes