NCT05689567

Focus-out Glasses on Emmetropization in Chinese Children

Effect of Peripheral Focus-out Glasses on Emmetropization in Chinese Children Aged 6-8 Years: 2 Years Randomized Clinical Trial.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 6 Years – 8 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to characterize the effects of peripheral focous-out glasses on emmetropization in non-myopic Chinese Children Aged 6-8 Years.This is a prospective, parallel-controlled randomized trial.

Detailed description

Myopia is one of the most common eye diseases that cause visual impairment and blindness, and the high rate of myopia in young people is a major public health issue. Based on the clinical studies of optical defocusing to regulate eye growth and refractive changes through visual signal feedback, we hypothesize that early wearing of peripheral defocus glasses in children can slow down the process of emmetropization and even prevent the onset of myopia by producing more myopic defocusing. The aim of this study is to investigate whether wearing peripheral defocus glasses can effectively delay emmetropization in non-myopic children aged 6-8 years , and to further explore its effect on preventing the onset of myopia. The study adopts a 2-year，single-centre, randomized, parallel-controlled trial with a non-blinded design. Subjects who pass the screening period will have their baseline data collected and will be assigned to the experimental or control groups according to the randomization principle. The experimental group will be fitted with Direct Emmetropia with Focus-out Glasses (hereafter referred to as DEFOG) to guide the emmetropization process. The control group will be given no treatment and will be a blank control. Baseline data including visual acuity, cycloplegic objective refraction, axis length, accommodation amplitude, strabismus examination, pupil size, choroidal thickness and peripheral retinal refraction will be measured when enrolled in the group and follow-up data will be measured at month 6, 12, 18 and 24. The primary interest of this study will be studied by comparing the difference in cycloplegic objective refraction changes between month 24 and baseline in the two groups of subjects.

Conditions

• Emmetropization
• Myopia
• Hyperopia

Interventions

Type	Name	Description
DEVICE	DEFOG glasses(peripheral focus-out glasses)	Subjects in the intervention group will wear peripheral focus-out glasses ≧8 hours a day and ≧5 days a week.

Timeline

• Start date: 2023-03-23
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2023-01-19
• Last updated: 2026-02-24

Locations

1 site across 1 country: China