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Slow Myopia Progression With Different Irradiance Light

NCT05881655 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-05-31

No results posted yet for this study

Summary

It is a prospective clinical control study on red light control myopia with specail design spectacles for 75 children in 3 groups. Study Groups with two different powers of 0.6 mW and 1.2 mW at wavelength of 650nm. The control group is to wear the same brand and design spectalces as those two study groups. In addition, the progression of myopia is usually accompanied by the changes in a variety of ocular parameters, such as refractive error, reduced submacular choroidal thickness, and prolonged length of the ocular axis length.The goal is to test which power (1.2mW and 0.6mW) is better in myopic children for 3 month's follow-up and also to test how to get better result with the increaing or decreasing lighting power for the total 6 month follow-up results .

Conditions

  • Myopia, Progressive

Interventions

DEVICE

Airdoc Red Lighting Device

A medical device with ultra low lever laser irradiance of 0.6mW or 1.2mW at the surface of cornea. And the therapy lasts 3 minutes with the 4 hours or more interval of break.

DEVICE

Special Spectacles to Control Myopia

Customer designed power and fitting to each subject for all the study periods.

Sponsors & Collaborators

  • Shanghai Children's Medical Center

    collaborator OTHER

  • Beijing Airdoc Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hong Liu, MD, PHD · Shanghai Children's Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-20
Primary Completion
2024-05-30
Completion
2025-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05881655 on ClinicalTrials.gov