Myopia Control Combined PBM With Myopic Defocus Lens in Children
NCT05756959 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 304
Last updated 2023-03-09
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.
Conditions
- Myopia, Progressive
Interventions
- 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)
Sponsors & Collaborators
-
The First People's Hospital of Xuzhou
collaborator OTHER -
Beijing Airdoc Technology Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Yan Wang, BA · The First People's Hospital of Xuzhou
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 13 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-12
- Primary Completion
- 2027-08-01
- Completion
- 2027-12-31
Countries
- China
Study Locations
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