NCT05550740

Repeated Low-Level Red-Light Therapy for Shortening Axial Length

Repeated Low-Level Red-Light Therapy for Shortening Axial Length in Chinese High Myopia Children and Teenagers: a Prospective Single-Arm Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center · Academic / Other
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical trial is to confirm the incidence and magnitude of axial length shortening after RLRL therapy in Chinese high myopia children and teenagers.

Detailed description

High myopia has become a major public concern globally, which is characterized by excessive axial elongation of the eyeball. Axial elongation is accompanied by mechanical stretching and thinning of the choroid and sclera, causing vision-threatening complications. RLRL therapy is an emerging effective and safe therapy for myopia control. Previous clinical trials in China have observed clinically significant axial shortening after RLRL treatment. The purpose of this study is to confirm and identify possible mechanism for axial length (AL) shortening after 12-month RLRL therapy in Chinese highly myopic children and teenagers aged 6-16 years. In addition to single vision spectacles, subjects will receive RLRL treatment at home under supervision of the parents according to a standard protocol. Axial length, visual acuity, cycloplegic spherical equivalent refraction, intraocular pressure, slit lamp, optical coherence tomography, optical coherence tomography angiography and ultrawide-field optical coherence tomography will be measured at 1-, 3-, 6- and 12-month follow-up visits. This trial will be extended to 3 years and follow-up visits are scheduled at 18-, 24-, 30- and 36-month.

Conditions

• High Myopia
• Refractive Errors
• Eye Diseases

Interventions

Type	Name	Description
DEVICE	RLRL	In addition to SVS with power for correcting distance refraction, RLRL will be performed twice per school day with an interval of at least 4 hours, each treatment last 3 minutes.

Timeline

• Start date: 2022-11-19
• Primary completion: 2026-03-01
• Completion: 2026-03-23
• First posted: 2022-09-22
• Last updated: 2025-03-30

Locations

1 site across 1 country: China