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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05550740
Study type Interventional
Source Shanghai Eye Disease Prevention and Treatment Center
Contact Xiangui He
Phone 021-62717733
Email hxgcrco@shsyf.com
Status Not yet recruiting
Phase N/A
Start date October 22, 2022
Completion date December 22, 2023

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