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

NCT06717048 | Recruiting DMC

• 1 other identifier: RLPT-SEPTC-2024
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myopia; Refractive Error - Myopia; Choroidal Thickness; Retina

Outcome Measures

Primary Outcomes (1)

• The incidence (%) of axial length increase ≤0.05mm after red light for 3 months measured by the IOL master

  Incidence rate of axial length shortening \> 0.05 mm is characterized as the ratio of number of participants with axial length shortening greater than 0.05 mm to the total number.

  1 week, 1, 2, 3 months

Secondary Outcomes (8)

• The incidence rates (%) of cycloplegic spherical equivalent refraction progressing ≥0.00 D after red light for 3 months measured by the autorefractor

  1 week, 1, 2, 3 months

• Changes of axial length (mm) after discontinuation of red light for 1 months measured by the IOL master

  4 months

• Changes of cycloplegic spherical equivalent refraction (D) after discontinuation of red light for 1 months measured by the autorefractor

  4 months

• Incidence (%) of self-reported adverse events by the quesionnaire including but not limited to glare, flash blindness, and afterimages

  1 week, 1, 2, 3, 4 months

• Change in visual acuity (logMAR) measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart

  1 week, 1, 2, 3, 4 months

Study Arms (9)

Red light: 2.0 mW/twice daily

EXPERIMENTAL

Device: Repeated Low-level Red-light

Red light: 2.0 mW/once daily

EXPERIMENTAL

Device: Repeated Low-level Red-light

Red light: 1.0 mW/twice daily

EXPERIMENTAL

Device: Repeated Low-level Red-light

Red light: 1.0 mW/once daily

EXPERIMENTAL

Device: Repeated Low-level Red-light

Red light: 0.5 mW/twice daily

EXPERIMENTAL

Device: Repeated Low-level Red-light

Red light: 0.5 mW/once daily

EXPERIMENTAL

Device: Repeated Low-level Red-light

Red light: 0.3 mW/twice daily

EXPERIMENTAL

Device: Repeated Low-level Red-light

Red light: 0.3 mW/once daily

EXPERIMENTAL

Device: Repeated Low-level Red-light

Red LED: twice daily

SHAM COMPARATOR

Device: Red LED

Interventions

Repeated Low-level Red-light DEVICE

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; Red light: 0.3 mW/twice daily; Red light: 0.5 mW/once daily; Red light: 0.5 mW/twice daily; Red light: 1.0 mW/once daily; Red light: 1.0 mW/twice daily; Red light: 2.0 mW/once daily; Red light: 2.0 mW/twice daily

Red LED DEVICE

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.

Red LED: twice daily

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Study Sites (1)

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Shanghai Municipality, 200041, China

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Xiangui He, Prof

CONTACT

+862153555032; hxgcrco@shsyf.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: December 4, 2024
• Study Start: December 9, 2024
• Primary Completion: April 9, 2025
• Study Completion: June 9, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)