NCT05532774

Efficacy and Safety of Defocusing Frame Glasses With Artificial Intelligence in Controlling Myopia Progression

Efficacy and Safety of Defocusing Frame Glasses With Artificial Intelligence in Children and Adolescents Controlling Myopia Progression: A Multicenter, Randomized, Parallel-Controlled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center · Academic / Other
• Sex: All
• Age: 7 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

Background: Myopia refers to the pathological state in which the external parallel light enters the eye and focuses in front of the retina, resulting in the inability to clearly image on the retina. The number of myopia in China ranks first in the world. According to statistics from the National Health and Health Commission, the myopia rate of children and adolescents nationwide in 2020 will be as high as 52.7%. High myopia often leads to permanent visual impairment and even blindness. Retinopathy complicated by high myopia has become the first irreversible blinding eye disease in Shanghai and other regions. The problem is severe. Therefore, it is necessary to actively seek effective myopia treatment and correction methods to slow down the progression of myopia and the excessive extension of the eye axis and reduce the occurrence of complications. Objective： On the basis of previous research, this study put forward the hypothesis that if behavior management (including outdoor light exposure and close-range eye-use behavior) can be strengthened in children with myopia wearing defocusing frame glasses, it is possible to achieve more effective myopia control effect, thereby not only ensuring safety also effectiveness. A randomized controlled clinical trial is conducted to evaluate the efficacy and safety of defocusing frame glasses with artificial intelligence in controlling myopia progression in children and adolescents. Intervention: Group 1 ( AI defocusing frame glasses group), Group 2 ( Ordinary defocusing frame glasses group). The study period will be 2 years and each participant will be followed up every six month.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	AI defocusing frame glasses	AI defocusing frame glasses have the function of eye behavior management, which can delay the progression of myopia through scientific management of eye behavior including outdoor light exposure (≥2 hours/day), duration of continuous close eye use (30 seconds rest every 30 minutes) and close eye distance (one punch, one foot and one inch), etc.

Timeline

• Start date: 2022-09-12
• Primary completion: 2024-09-12
• Completion: 2024-11-30
• First posted: 2022-09-08
• Last updated: 2022-10-04

Locations

1 site across 1 country: China