NCT06232161

Sustained Effect of Red-light Therapy for Myopia Control: A 2-Year Post-Trial Follow-up Study

Retrospective,2-Year Post-Trial Follow-up Study of Sustained and Rebound Effect of Red-light Therapy for Myopia in Ningbo.
Beijing Airdoc Technology Co., Ltd.·ClinicalTrials.gov·device·Device trialRecruitment Completed
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Study focus
Disease/Condition
Myopia
Drug/Device/Intervention
Red-light therapy device
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Beijing Airdoc Technology Co., Ltd.
Location
Ningbo, China
Timeline & enrollment
Phase
N/A
Start date
May 13, 2020
End date
Dec 31, 2026
Enrollment
50 participants
Primary outcome

Change of axial length (mm) with the measurement of device named by IntraOcular Lens Master(IOLmaster 500)

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.

ICD-10 classifications
MyopiaDegenerative myopiaAmblyopia ex anopsiaOcular myiasisMyiasis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06232161
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06232161 through Pure Global AI's free database. This phase not specified trial is sponsored by Beijing Airdoc Technology Co., Ltd. and is currently Recruitment Completed. The study focuses on Myopia. Target enrollment is 50 participants.

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