Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06232161
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-01-20
Brief Title:
Sustained Effect of Red-light Therapy for Myopia Control A 2-Year Post-Trial Follow-up Study
Sponsor:
Beijing Airdoc Technology Co Ltd
Organization:
Beijing Airdoc Technology Co Ltd
Study Overview
Official Title:
Retrospective2-Year Post-Trial Follow-up Study of Sustained and Rebound Effect of Red-light Therapy for Myopia in Ningbo
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
To evaluate the long-term efficacy and safety of red-light therapy for myopia control over 2 years and the potential rebound effect after treatment cessation
The Chinese myopic children who originally completed the one-year randomised controlled trial in the previous study were enrolled Children continued or started to daily usage of red-light therapy were defined as the RL group while those who stopped using red-light therapy and switched to single-vision spectacles SVS as well as those who continued to keep single-vision spectacles in the second year were both regarded as the SVS group Red-light therapy was provided by an at-home desktop light device emitting red-light of 650 nm and was administered for 3 min at a time twice a day Changes in axial length AL and cycloplegic spherical equivalence refraction SER are to be measured and compared as well as the adverse effects including the rebound effect
Red-light therapy has emerged as a novel myopia control treatment modality recently A 12-month randomised controlled trial RCT conducted by our research team was thought to be earlier to evaluate the treatment of myopic children using red-light therapy The trial demonstrated that PBM therapy was effective on myopia control reducing axial elongation and spherical equivalence refraction SER progression 103 and 127 compared with single vision spectacle SVS over a 12-month period respectively The promising efficacy of red-light therapy has been further confirmed in other studies In addition satisfactory user acceptability and no unrecovered functional and structural damages were observed
Myopia generally progresses throughout childhood and hence a study duration of 1 year is not sufficient to widely adopt the red-light therapy as a treatment strategy for myopia control The sustainability of treatment efficacy rebound phenomenon upon cessation of treatment and potential risks and adverse effects in myopic children with longer-term PBM therapy remain to be fully elucidated
Thus the aims of this post-trial follow-up study were to invite the participants to come back for a 24-month visit and to investigate the long-term efficacy and safety of continued red-light therapy as well as the potential rebound effect following red-light treatment cessation
The Chinese myopic children who originally completed the one-year randomised controlled trial in the previous study were enrolled Children continued or started to daily usage of red-light therapy were defined as the RL group while those who stopped using red-light therapy and switched to single-vision spectacles SVS as well as those who continued to keep single-vision spectacles in the second year were both regarded as the SVS group Red-light therapy was provided by an at-home desktop light device emitting red-light of 650 nm and was administered for 3 min at a time twice a day Changes in axial length AL and cycloplegic spherical equivalence refraction SER are to be measured and compared as well as the adverse effects including the rebound effect
Red-light therapy has emerged as a novel myopia control treatment modality recently A 12-month randomised controlled trial RCT conducted by our research team was thought to be earlier to evaluate the treatment of myopic children using red-light therapy The trial demonstrated that PBM therapy was effective on myopia control reducing axial elongation and spherical equivalence refraction SER progression 103 and 127 compared with single vision spectacle SVS over a 12-month period respectively The promising efficacy of red-light therapy has been further confirmed in other studies In addition satisfactory user acceptability and no unrecovered functional and structural damages were observed
Myopia generally progresses throughout childhood and hence a study duration of 1 year is not sufficient to widely adopt the red-light therapy as a treatment strategy for myopia control The sustainability of treatment efficacy rebound phenomenon upon cessation of treatment and potential risks and adverse effects in myopic children with longer-term PBM therapy remain to be fully elucidated
Thus the aims of this post-trial follow-up study were to invite the participants to come back for a 24-month visit and to investigate the long-term efficacy and safety of continued red-light therapy as well as the potential rebound effect following red-light treatment cessation
Detailed Description:
Interventions and visits All spectacle lenses were made for single focus with full correction for each subject as the first intervention throughout the whole procedure for both groups PBM therapy was performed with a low-intensity laser LD-A Jilin LD Optoelectronics Technology Jilin China with an irradiance of 035 002 mWcm2 a wavelength of 650 nm 10 nm and illumination of approximately 400 lux on average at the first 12 month At the second 12 months non-randomized cohorts continued according to the willing to use the device from both groups Once decided those usage would be followed up for another 12 months for tracking the change of axial length as well as the change of refractive error All the adverse effects and any harms are encouraged to report during the next 12 months study
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