Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05947019
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-14
First Post:
2023-07-07
Brief Title:
Efficacy and Safety of Low-Level Monochromatic Red-Light for High Myopia Control in Adults
Sponsor:
Shanghai Eye Disease Prevention and Treatment Center
Organization:
Shanghai Eye Disease Prevention and Treatment Center
Study Overview
Official Title:
Efficacy and Safety of Low-Level Monochromatic Red-Light for High Myopia Control in Adults A Randomized Controlled Multicenter Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
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:
The purpose of this clinical study is to confirm the effectiveness and safety of low-level monochromatic red-light for high myopia control in adults
Detailed Description:
Currently there is still a lack of effective methods for managing adult high myopia globally The Elsing Myopia and Amblyopia Therapy Instrument developed by Suzhou Industrial Park Zuoguan Medical Equipment Co Ltd has gained widespread usage in mainland China for amblyopia treatment and myopia control This instrument utilizes low-intensity laser therapy LLLT for treatment demonstrating improvements in visual acuity without any local or systemic side effects The low-intensity laser induces photochemical reactions in the retina such as enhancing cytochrome C oxidase activity modulating gene expression to regulate the mitochondrial respiratory chain and increasing the biological activity of nitric oxide These mechanisms have been applied in the treatment of age-related macular degeneration and diabetic retinopathy As the onset of myopia is closely linked to retinal signaling pathways preliminary test data suggests that the instrument can significantly slow down myopia progression This study aims to investigate the potential of low-intensity laser therapy in preventing and treating high myopia in adults providing innovative approaches to mitigate the widespread impact of high myopia
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