RecruitingNot ApplicableNCT06717048

Minimum Power and Frequency of Repeated Low-level Red-light to Effectively Control Myopia Progression

An Exploratory Study on the Minimum Power and Frequency of Repeated Low-level Red-light to Effectively Control Myopia Progression


Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Enrollment

108 participants

Start Date

Dec 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To explore the minimum power and frequency of Repeated Low-level Red-light (RLRL) to control myopia progression in low-myopic children aged 8-10 years, and the rebound effect of low-myopic children after discontinuation of RLRL with different combinations of power and frequency.


Eligibility

Min Age: 8 YearsMax Age: 10 Years

Inclusion Criteria3

  • Age: 8-10 years old
  • 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.
  • signed informed consent and was able to participate in the study

Exclusion Criteria9

  • Secondary myopia, such as a history of retinopathy of prematurity or other neonatal diseases; syndromic myopia with a known genetic disorder or connective tissue disease, such as Stickler syndrome or Marfan syndrome
  • Strabismus or other binocular vision abnormalities
  • Cloudy refractive media: cloudy cornea, cataract or intraocular lens surgery
  • Eye diseases that affect retinal function: macular degeneration, diabetic retinopathy, retinal detachment, glaucoma or ocular hypertension, endophthalmitis, uveitis, optic neuropathy, etc.
  • History of refractive surgery, internal eye surgery, laser therapy, vitreous injection, etc.
  • diabetes, hypertension and other systemic disorders
  • History of use of retinal toxic drugs, such as hydroxychloroquine, etc.
  • 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.
  • Other reasons considered unsuitable for inclusion by the study physician, including but not limited to other ocular and systemic disease abnormalities

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Interventions

DEVICERepeated 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.

DEVICERed 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.


Locations(1)

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Shanghai Municipality, China

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NCT06717048


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