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

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated February 14, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary endpoint revisedv2 Show 6 more changesShow less
    • Interventions: PBM therapy device (Device), spectacles (Device) to Red-light therapy device (Device), Spectacles (Device)
    • Eligibility criteria shortened, about 77 words
    • Secondary endpoint revised
    • Study arms: 4 to 2
    • Study description shortened, about 1 word
    • Study title shortened, about 2 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06232161
Lead Sponsor Beijing Airdoc Technology Co., Ltd.
Collaborators: Ningbo Eye Hospital
Conditions
(from sponsor)
Myopia
Related terms Myopia
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov