Minimum Power and Frequency of Repeated Low-level Red-light to Effectively Control Myopia Progression
NCT ID: NCT06717048
Last Updated: 2024-12-04
Study Results
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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RECRUITING
NA
108 participants
INTERVENTIONAL
2024-12-09
2025-06-09
Brief Summary
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Detailed Description
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In recent years, RLRL holds significant potential as an effective strategy for preventing and controlling myopia in children and adolescents. However, recent researches prompt further questions: Is the current power of RLRL exposure optimal? Can the frequency of exposure be refined? What is the relationship among exposure power, frequency and myopia control? To explore these questions and clarify the effects of various combinations of exposure power and frequency on myopia progression following RLRL therapy, our research group plans to conduct a prospective, double-blind, single-center, randomized controlled clinical trial. This study aims to provide more comprehensive evidence to support this innovative intervention on myopia prevention and control.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Red light: 2.0 mW/twice daily
Repeated Low-level Red-light
In addition to single vision spectacle lenses (SVS) with power for correcting distance refraction, the subjects used the prescribed power low-intensity red light treatment instrument for the prescribed number of treatments from Monday to Friday, with a 3-minute interval of 4 hours.
Red light: 2.0 mW/once daily
Repeated Low-level Red-light
In addition to single vision spectacle lenses (SVS) with power for correcting distance refraction, the subjects used the prescribed power low-intensity red light treatment instrument for the prescribed number of treatments from Monday to Friday, with a 3-minute interval of 4 hours.
Red light: 1.0 mW/twice daily
Repeated Low-level Red-light
In addition to single vision spectacle lenses (SVS) with power for correcting distance refraction, the subjects used the prescribed power low-intensity red light treatment instrument for the prescribed number of treatments from Monday to Friday, with a 3-minute interval of 4 hours.
Red light: 1.0 mW/once daily
Repeated Low-level Red-light
In addition to single vision spectacle lenses (SVS) with power for correcting distance refraction, the subjects used the prescribed power low-intensity red light treatment instrument for the prescribed number of treatments from Monday to Friday, with a 3-minute interval of 4 hours.
Red light: 0.5 mW/twice daily
Repeated Low-level Red-light
In addition to single vision spectacle lenses (SVS) with power for correcting distance refraction, the subjects used the prescribed power low-intensity red light treatment instrument for the prescribed number of treatments from Monday to Friday, with a 3-minute interval of 4 hours.
Red light: 0.5 mW/once daily
Repeated Low-level Red-light
In addition to single vision spectacle lenses (SVS) with power for correcting distance refraction, the subjects used the prescribed power low-intensity red light treatment instrument for the prescribed number of treatments from Monday to Friday, with a 3-minute interval of 4 hours.
Red light: 0.3 mW/twice daily
Repeated Low-level Red-light
In addition to single vision spectacle lenses (SVS) with power for correcting distance refraction, the subjects used the prescribed power low-intensity red light treatment instrument for the prescribed number of treatments from Monday to Friday, with a 3-minute interval of 4 hours.
Red light: 0.3 mW/once daily
Repeated Low-level Red-light
In addition to single vision spectacle lenses (SVS) with power for correcting distance refraction, the subjects used the prescribed power low-intensity red light treatment instrument for the prescribed number of treatments from Monday to Friday, with a 3-minute interval of 4 hours.
Red LED: twice daily
Red LED
In addition to SVS with power for correcting distance refraction, red LED will be performed twice per school day with an interval of at least 4 hours, each treatment last 3 minutes.
Interventions
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Repeated Low-level Red-light
In addition to single vision spectacle lenses (SVS) with power for correcting distance refraction, the subjects used the prescribed power low-intensity red light treatment instrument for the prescribed number of treatments from Monday to Friday, with a 3-minute interval of 4 hours.
Red LED
In addition to SVS with power for correcting distance refraction, red LED will be performed twice per school day with an interval of at least 4 hours, each treatment last 3 minutes.
Eligibility Criteria
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Inclusion Criteria
2. Low myopia: cycloplegic spherical equivalent refractions (SERs) range from -0.50 (inclusive) to -3.00 diopters (D) and astigmatism less than -2.5 D in either eye.
3. signed informed consent and was able to participate in the study
Exclusion Criteria
2. Strabismus or other binocular vision abnormalities
3. Cloudy refractive media: cloudy cornea, cataract or intraocular lens surgery
4. Eye diseases that affect retinal function: macular degeneration, diabetic retinopathy, retinal detachment, glaucoma or ocular hypertension, endophthalmitis, uveitis, optic neuropathy, etc.
5. History of refractive surgery, internal eye surgery, laser therapy, vitreous injection, etc.
6. diabetes, hypertension and other systemic disorders
7. History of use of retinal toxic drugs, such as hydroxychloroquine, etc.
8. Use of orthokeratology, atropine, multifocal frame glasses and other myopia control methods; children who are currently receiving atropine, orthokeratology, multifocal frame glasses and other myopia control treatment, can be enrolled after 2 weeks of treatment.
9. Other reasons considered unsuitable for inclusion by the study physician, including but not limited to other ocular and systemic disease abnormalities
8 Years
10 Years
ALL
Yes
Sponsors
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Shanghai Eye Disease Prevention and Treatment Center
OTHER
Responsible Party
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Locations
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Shanghai Eye Disease Prevention & Treatment Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xiangui He
Role: primary
Kaidi Xiang
Role: backup
Other Identifiers
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RLPT-SEPTC-2024
Identifier Type: -
Identifier Source: org_study_id