Traumatic Optic Neuropathy (TON)
Conditions
Interventions
Group B:WZ-6600 Nasal Drops
Group A:WZ-6600 Nasal Drops + Endoscopic Transnasal Optic Canal Decompression (ETOCD)
Group C:Placebo Nasal Drops + Endoscopic Transnasal Optic Canal Decompression (ETOCD)
Group D:Placebo Nasal Drops
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
12 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Meeting the diagnostic criteria for TON; 2. Unilateral traumatic optic neuropathy; 3. BCVA of the injured eye ranging from 0.02 to 0.3 (decimal visual acuity); 4. Time since injury less than 3 months; 5. Aged between 12 and 45 years old; 6. Patients who fully understand the safety profile of the study, are willing to actively cooperate with the research, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Complicated with craniocerebral trauma or history of craniocerebral surgery; 2. Cerebral tumors or cerebrovascular diseases; 3. Complicated with severe systemic diseases, such as poorly controlled hypertension, poorly controlled diabetes mellitus, or autoimmune diseases; 4. History of previous ophthalmic surgery; 5. Presence of ocular disorders that may affect visual function, including corneal ulcer, cataract, retinal vascular diseases, retinal detachment, and other optic nerve diseases; 6. History of genetic diseases; 7. History or family history of neurological diseases or psychiatric disorders; 8. Severe major systemic diseases such as cardiac, hepatic, or renal insufficiency; 9. Pregnant, lactating women, or women with plans for pregnancy within the next 6 months; 10. Participation in other clinical trials within the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best-Corrected Visual Acuity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Macular Vascular Density;Macular Retinal Thickness;Visual Evoked Potential(VEP);Visual Field;Optic Disc Vascular Density;Ganglion Cell Complex Thickness;Retinal Nerve Fiber Layer Thickness; | — |
Countries
China
Contacts
Public ContactWu Wencan
Eye Hospital, Wenzhou Medical University
Outcome results
None listed