Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT05728762 |
Other study ID # |
2022KYPJ192 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 22, 2023 |
Est. completion date |
December 2025 |
Study information
Verified date |
March 2024 |
Source |
Zhongshan Ophthalmic Center, Sun Yat-sen University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this clinical trial is to evaluate the effect of light-emitting diodes (LEDs)
with a continuous spectrum of 430-780 nm for lighting in the classroom on myopia prevention
among children in Grades 2 and 3.
Description:
Myopia is a common condition that primarily arises in childhood and remains the most
important cause of vision loss for children. Irreversible vision-threatening ocular
complications such as posterior staphyloma, myopic maculopathy, and glaucoma may occur with a
dramatically high risk once myopia progresses to high myopia. Considering the striking rapid
increases in the prevalence of myopia and the premature age of myopia onset, myopia
prevention is of extreme urgency and presents several challenges.
It has been proven with solid evidence that outdoor times has effects on myopia prevention,
which may be attributed to outdoor light exposure. However, it is difficult to meet the
required outdoor times (i.e., at least 2 hours/day) for school-aged children under such
educational pressure, especially in China. The differences between the light outdoors and
indoors in terms of the light spectrum provide some insights into research to find the
alternative. The growth rate of the vitreous cavity in juvenile and adult tree shrews grown
under red light with a wavelength of 628±10 nm was significantly slower than those grown
under the normal fluorescent lighting group, and red light could induce a hyperopic shift in
juvenile tree shrews, thus slowing down the development of myopia. Another experiment has
also shown that the use of full-spectrum LED covering a continuous spectrum of 400-775 nm
accelerated the recovery from form-deprivation myopia in chickens, and it is hypothesized
that full-spectrum lighting may affect the choroid-scleral remodeling pathway, which is
thought to be associated with myopia control.
The purpose of this study is to evaluate the effects of LEDs covering a continuous spectrum
of 430-780 nm for lighting in the classroom (intervention arm) among students in Grades 2 and
3 compared with regular LEDs with a spectrum of 430-630 nm (control arm). Cluster
randomization by class was chosen, and all classes in the same school and grade were equally
and randomly assigned to the intervention or control arm, with follow-ups at 1- and 2-year.
Vision acuity, ocular biometry, cycloplegic refraction, slit-lamp examinations, optical
coherence tomography, optical coherence tomography angiography, and questionnaires will be
performed at baseline and during the follow-up.