机构：[1]State Key Laboratory of Ophthalmology, Wenzhou Medical University, Wenzhou, China.[2]Department of Ophthalmology, The Second Hospital of Jilin University, Changchun, China.[3]Department of Otolaryngology-Head and Neck Surgery, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.中山大学附属第三医院[4]The third Xiangya Hospital of Central South University, Changshao, China.[5]Li Huili Hospital affiliated with Ningbo University CN, Ningbo, China.[6]Shenzhen Eye Hospital, Jinan University, Shenzhen, China.[7]The Fourth People's Hospital of Shenyang, Shenyang, China.[8]First People's Hospital of Xuzhou, Xuzhou, China.[9]Jiaxing Hospital of Traditional Chinese Medicine, Jiaxing, China.[10]Shananxi Eye Hospital, Affiliated People's Hospital 24 of Northwest University, Xian, China.[11]The First Affiliated Hospital of Dali University, Dali, China.[12]Department of Ophthalmology, The Fourth Affiliated Hospital of China Medical University, Shenyang, China.[13]Eye Institute, Affiliated Hospital of Nantong University, Nantong, China.[14]Department of Neurosurgery, Capital Medical University, Tongren, China.[15]Peoples Hospital of Ningxia Hui Autonomous Region, Yinchuan, China.[16]Eye Hospital, State Key Laboratory of Eye Health /Institute for Advanced St, Wenzhou Medical University, Wenzhou, China.[17]Jiangsu JITRI Sioux Technologies Company, Suzhou, China.[18]Institute for Advanced Study on Eye Health and Diseases, Wenzhou Medical University, Wenzhou, China.
Traumatic optic neuropathy (TON) is a leading cause of blindness following closed traumatic brain injury, with no effective treatments available. Previous interventional clinical trials were complicated by its low prevalence, variability in neurodegenerative severity, and unavailability of reliable biomarkers.We analyzed data from 1226 patients enrolled in the prospective National Multi-Center Collaborative Clinical Research Program of China (2017-2024) to establish a clinical profile and identify non-invasive biomarkers for neurodegenerative severity. Subgroup analysis of monocular TON patients revealed potential biomarkers including visual functional parameters, inner retinal thickness, and time post-injury.The ganglion cell complex (GCC) thickness showed a strong correlation with retinal ganglion cell somata (R² = 0.87, p < .0001) and axon density (R² = 0.89, p < .0001) in a clinically relevant large animal model. Computational analysis demonstrated that using GCC thickness as a biomarker could substantially enhance the statistical power of clinical trials (by up to 4.5-fold), as confirmed by real-world data.This study presented the largest epidemiological analysis of TON to date and established GCC thickness as a crucial biomarker for stratifying disease severity and improving the efficiency of clinical trials.Chinese Clinical Trial Registry (ChiCTR-OOC-17013437).National Key R&D Program of China (Grant No.2022YFA1105500); Key Science and Technology Program of Wenzhou (Grant No.ZY2022021); National Natural Science Foundation of China (Grant No.82471080).
基金：
National Key R&D Program of China (Grant No. 2022YFA1105500), Key Science and
Technology Program of Wenzhou (Grant No. ZY2022021), National Natural Science Foundation of China
(Grant No. 82471080).
医学