Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05871840 |
Other study ID # |
LL-KT-2023006-X1 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 2023 |
Est. completion date |
December 2024 |
Study information
Verified date |
May 2023 |
Source |
Shenzhen Hospital (Guangming), University of Chinese Academy of Sciences |
Contact |
Xiong Jiping |
Phone |
18126081918 |
Email |
377721053[@]qq.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Myopia has become one of the leading causes of visual impairment globally and brings a heavy
burden on the society. Therefore, preventing and controlling the progression of myopia has
become an urgent public health issue that needs to be addressed.
The purpose of this study is to provide real-world evidence for identifying the incidence of
myopia control (axial length growth rate ≤ 0.1mm/year) after 36-month RLRL therapy, and
long-term safety of RLRL therapy in children and adolescents.
Description:
The prevalence of myopia in children is increasing worldwide and is viewed as a major public
health concern. The current methods for myopia control include medication (e.g., atropine eye
drops), optical (e.g., orthokeratology) and environmental interventions (e.g., time
outdoors). Nevertheless, these treatments still have limitations. For example,
low-concentration atropine may cause systemic side effects and accommodation loss caused by
ciliary muscle paralysis. Moreover, the use of orthokeratology in children poses problems
such as difficulty wearing, low compliance, and possible complications such as severe corneal
infections. Thus, developing the more effective and safe treatment for myopia control in
children and adolescents is the future research direction.
Recently, repeated low-level red-light (RLRL) therapy has emerged as a treatment for myopia
control in children and adolescents, with promising efficacy and safety. It is suggested that
continued RLRL therapy sustained promising efficacy and safety in slowing myopia progression
within 2 years. However, relevant information on the effectiveness and safety of RLRL therapy
on myopia control over 2 years among children and adolescents remain scarce, which deserves
to be further explored.
In this multicenter observational study, the investigators aim to recruit 360 children aged
7-18 years who have currently accepted RLRL therapy at 3 study centers in China. All
participants are randomly selected by stratified sampling based on the treatment duration of
RLRL therapy (6-12 months, 12-24 months, 24-36 months, 36 months or more). First, the
investigators will confirm whether these participants have pre-treatment data (before
starting RLRL therapy), including visual acuity, axial length and cycloplegic refraction.
Then all the eligible participants who meet the preliminary inclusion criteria, will be
invited to come to the corresponding hospitals and further undergo the comprehensive
ophthalmic examinations, including visual acuity, measurement of ocular biometric parameters,
cycloplegic refraction, slit-lamp examination, color fundus photography, optical coherence
tomography (OCT), electroretinography (ERG) and questionnaire surveys.