NCT05756959

Myopia Control Combined PBM With Myopic Defocus Lens in Children

Myopia Control Combined PBM With Myopic Defocus Lens in Children: Double-blind RCT for 6 Month

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 304 (estimated)
• Sponsor: Beijing Airdoc Technology Co., Ltd. · Industry
• Sex: All
• Age: 6 Years – 13 Years
• Healthy volunteers: Not accepted

Summary

To study the efficacy of myopi control with two methods: low lever red light and peripheral defocus spectacles with four groups and design with prospective, double-blind, randimized, and with control for 6 month.

Detailed description

myopic children with age from 6 \~13 years old. And refraction from -0.50D\~-5.50D. The red light is low lever laser therapy at wavelength of 650nm.

Conditions

• Myopia, Progressive

Interventions

Type	Name	Description
DEVICE	PBM	PBM, is a low intensity red light at wavelength of 650nm; Peripheral defocus spectacels is a peripheral design glasseses for correct myopia and control myopia
DEVICE	Peripheral defocus spectacles	plus power design of many peripheral small lenses to achieve myopic defocus of the retina in the peripheral retina
DEVICE	Single vision spectacles	Distance vision correction with the single vision spectacles for the myopia correction methods (glasseses for myopia correction)

Timeline

• Start date: 2022-12-12
• Primary completion: 2027-08-01
• Completion: 2027-12-31
• First posted: 2023-03-07
• Last updated: 2023-03-09

Locations

1 site across 1 country: China