Traumatic optic neuropathy
Conditions
Interventions
Experimental Group:Perform conventional Endoscopic Transnasal Optic Canal Decompression (ETOCD) including 180° bone removal and dural puncture, followed by minimally invasive transplantation of Gefu-C
Control Group:Perform identical conventional Endoscopic Transnasal Optic Canal Decompression (ETOCD), followed by transplantation of blank biological gelatin material at the lesion site as a control
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
8 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Clinically diagnosed with optic neuropathy. According to the "Expert Consensus on Endoscopic Transnasal Optic Canal Decompression for Traumatic Optic Neuropathy in China (2016)", the diagnostic criteria for TON are as follows: Necessary conditions: (1) History of trauma to the skull, orbit, or maxillofacial region, especially the frontal or temporal areas; (2) Acute visual function impairment after injury, such as decreased vision or blindness, visual field defects, color vision disorders, etc., excluding causes from previous diseases. Supporting conditions: (1) Positive RAPD, with no intraocular abnormality causing RAPD; (2) F-VEP examination showing disappearance of visual waveform or prolonged P100 latency and reduced amplitude, with no severe retinal lesions observed. When one eye is affected or bilateral involvement is asymmetrical, the supporting condition (1) applies; when both eyes are affected similarly, supporting condition (2) applies. If both necessary conditions are present, TON can be diagnosed. 2. Within 3 months of injury; 3. Age between 8 and 50 years; 4. Single-eye injury; 5. Best-corrected visual acuity of the injured eye ranging from light perception to 20/200; 6. RNFL and GCC layer atrophy in the injured eye compared to the contralateral eye is less than or equal to 30%; 7. Corticosteroid shock therapy is ineffective; 8. The patient is conscious, expresses clearly, voluntarily participates in this study, and personally signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Combined with retinal or optic nerve avulsion; 2. Preoperative CTA vascular scan reveals definite or suspected abnormalities of the internal carotid artery or ophthalmic artery; 3. Presence of surgical contraindications, or preoperative indications of chronic sinus infection; 4. Suffering from other ocular diseases (including vitreous hemorrhage, glaucoma, or high myopia); 5. Opacity of refractive media; 6. History of diabetes mellitus; 7. Lack of capacity or limited capacity for informed consent; 8. Lack of civil capacity or limited civil capacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity (BCVA); | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Field;Flash visual evoked potential;Peripapillary RNFL thickness;Pattern visual evoked potential;Pattern electroretinogram;Evaluation of wound and local site conditions; | — |
Countries
China
Contacts
Public ContactWu Wencan
Eye Hospital, Wenzhou Medical University
Outcome results
None listed