Nonarteritic anterior ischemic optic neuropathy
Conditions
Interventions
Surgical treatment group:Vitrectomy
Control group:None
Sponsors
Department of Ophthalmology, First Medical Center, PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria for inclusion in this study: 1) Age 18-70 years old (including the cut-off value), male or female; 2) meet the diagnostic criteria for non-arteritic anterior ischemic optic neuropathy; 3) 30 days = onset; 4) Monocular onset: the best corrected visual acuity at the time of presentation is 0.04~0.5; 5) OCT showed peripapillary edema and incomplete retrovitreous detachment with peripapillary wrinkles; 6) Willing to obey this trial protocol and voluntarily sign the informed consent form. Attached: Diagnostic criteria for the diagnosis of non-arteritic anterior ischemic optic neuropathy (expert consensus on the diagnosis and treatment of non-arteritic anterior ischemic optic neuropathy in China (2015): (1) Sudden onset of visual field defects and/or painless vision loss; (2) Visual field examination showed quadrant visual field defects connected to physiological blind spots that bypassed the central fixation, mostly located on the nasal side and below; (3) localized or diffuse papilledema, often accompanied by peripheral linear hemorrhage; (4) the presence of relative afferent pupillary dysfunction and/or visual evoked potential abnormalities; (5) Exclude other optic neuropathy.
Exclusion criteria
Exclusion criteria: Subjects cannot be enrolled if they meet any of the following criteria: 1) Patients with other serious eye diseases that affect visual function, such as glaucoma, corneal inflammation and opacity, uveitis, obvious lens opacity, diabetic proliferative retinopathy, temporal arteritic anterior ischemic neuropathy, macular hole, retinal detachment, retinitis pigmentosa, etc.; 2) the affected eye has undergone vitrectomy surgery in the past; 3) Active ocular infection (e.g., conjunctivitis, keratitis, scleritis, endophthalmitis, etc.) in the target eye or contralateral eye; 4) Patients with hemorrhagic tendency, patients with acute stage of cerebral hemorrhage; 5) Patients with severe heart diseases (including but not limited to: severe arrhythmia, heart failure, abnormal or frequent angina, acute coronary syndrome); 6) Those who underwent corneal refractive surgery, cataract surgery, glaucoma surgery and other eye surgeries within 3 months before enrollment; 7) Combined with severe liver and kidney diseases, or abnormal liver and kidney function tests (ALT, AST = 1.5 times the upper limit of normal, SCr > upper limit of normal); 8) Patients with poor blood sugar control; 9) Patients with poor blood pressure control; 10) Suffering from active infectious diseases (such as syphilis, AIDS, tuberculosis, etc.); 11) Those who have a clear history of serious other systemic diseases that are receiving or need to be treated, or diseases that interfere with the treatment of this study (such as tumors, organ failure, coagulation dysfunction, etc.); 12) Those who know or suspect a history of allergy or serious adverse reactions to the test drug and its excipients, or those who are allergic; 13) Those who are unable to cooperate or unwilling to cooperate due to neurological or psychiatric disorders; 14) Those who have participated in other clinical trials within 3 months before enrollment; 15) Pregnant or lactating women, who have planned to have a child in the past six months; 160 Those who, in the judgment of the investigator, are not suitable to participate in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in best-corrected visual acuity (BCVA) after 12 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The mean defect (MD) and standard deviation of the pattern (PSD) of the visual field changed at 1 week, 4 weeks, and 12 weeks after treatment;Change from baseline in best-corrected visual acuity (BCVA) at 1 week and 4 weeks after treatment;Percentage of patients with BCVA recovery of =15 letters from baseline at 1 week, 4 weeks, and 12 weeks after treatment;OCT measured the posterior vitreous detachment and peripapillary wrinkles at 1 and 4 weeks after treatment;OCT measured the changes in the thickness of the nerve fiber layer in the four quadrants around the optic disc at 1 week, 4 weeks, and 12 weeks after treatment;OCT measured the changes in macular GCC thickness at 1 week, 4 weeks, and 12 weeks after treatment; | — |
Countries
China
Contacts
Public ContactShihui Wei
The First Medical Center of PLA General Hospital
Outcome results
None listed