Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05871840
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-22
First Post:
2023-05-15
Brief Title:
Effectiveness and Safety of Repeated Low-Level Red-Light Therapy on Myopia Control Among Children and Adolescents
Sponsor:
Shenzhen Hospital Guangming University of Chinese Academy of Sciences
Organization:
Shenzhen Hospital Guangming University of Chinese Academy of Sciences
Study Overview
Official Title:
Real-World Evidence Effectiveness and Safety of Repeated Low-Level Red-Light Therapy on Myopia Control Among Children and Adolescents
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 01mmyear after 36-month RLRL therapy and long-term safety of RLRL therapy in children and adolescents
The purpose of this study is to provide real-world evidence for identifying the incidence of myopia control axial length growth rate 01mmyear after 36-month RLRL therapy and long-term safety of RLRL therapy in children and adolescents
Detailed 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 eg atropine eye drops optical eg orthokeratology and environmental interventions eg 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None