Clinical Trials Directory

Trials / Completed

CompletedNCT06683287

Effects of Low-Level Red Light and Distant-Image Screen for Myopia Control in Children

Effects of Low-Level Red Light and Distant-Image Screen for Myopia Control in Children: a Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
120 (actual)
Sponsor
Beijing Tongren Hospital · Academic / Other
Sex
All
Age
8 Years – 12 Years
Healthy volunteers
Not accepted

Summary

This study aims to assess the efficacy and safety of daily exposure to 650-nm low-level red light (RL) and distant-image therapy (DIT) for myopia treatment.

Detailed description

This was a randomized clinical trial. Children aged 8 to 10 years with a spherical equivalent error (SER) ranging from -1 to -1.5 diopters (D) were enrolled, and were randomly allocated to the following treatment group: RL, DIT, RL plus DIT, and control in a 1:1:1:1 ratio. The primary outcomes were one-year change in SER and axial length.

Conditions

Interventions

TypeNameDescription
DEVICEred light and distant image screenred light plus distant image screen, children use these two devices at the same time
DEVICEred lightchildren use red light for 3 minutes each time, twice a day
DEVICEdistant image screenChildren in this group were asked to use this device for ≥1 hour/day

Timeline

Start date
2023-04-10
Primary completion
2023-05-15
Completion
2023-05-15
First posted
2024-11-12
Last updated
2024-11-12

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06683287. Inclusion in this directory is not an endorsement.