NCT06232161

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

Active, enrolled NA Last updated 14 February 2024

What this trial tests

NA trial testing Red-light therapy device in Myopia in 50 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

13 May 2020

Primary endpoint
31 December 2024

31 December 2026

Quick facts

Lead sponsor	Beijing Airdoc Technology Co., Ltd.
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	13 May 2020
Primary completion	31 December 2024
Estimated completion	31 December 2026
Sites	1 location across China

Drugs / interventions tested

• Red-light therapy device
• Spectacles

Conditions studied

• Myopia — all drugs for Myopia →

Sponsor

Beijing Airdoc Technology Co., Ltd.

Who can join

Adults 9 to 13, any sex, with Myopia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.