Severe retinal detachment
Conditions
Interventions
Control Group:Intraocular filling with silicone oil Oxane 5700 Silicone Oil for ophthalmic surgery.
Test Group:Shanghai Sunvista Medical Technology Co., Ltd. Silicone oil intraocular filling for ophthalmic surgery
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years (inclusive of the threshold), gender is not limited; 2.Severe retinal detachment requiring intraocular filling that cannot be treated by other means, including: Severe proliferative vitreoretinopathy (PVR grade C3 or D) ; Large lacunae (lacunae >=90° in extent) or multiple lacunae combined with retinal detachment;Traumatic eye injury combined with retinal detachment d. Other conditions that, in the judgment of the investigator, meet the indications for silicone oil filling; 3. Voluntarily participate in this clinical trial and sign the subject informed consent form.
Exclusion criteria
Exclusion criteria: 1. Persons who have retinopathy in both eyes and require simultaneous surgical treatment; 2. Persons with severe iris redness in the affected eye; 3. Persons with atrophy of the affected eye or severe retinal atrophy of the posterior pole; 4. The presence of acute inflammation in the affected eye, especially infectious keratitis and chronic dacryocystitis, or a history of severe uveitis; 5. Combined glaucoma and poorly controlled intraocular pressure (>25mmHg) despite medication; 6. Persons with diabetic retinopathy, or diabetic patients without good glycemic control who have a fasting blood glucose of 10 mmol/L or more or a glycosylated hemoglobin of 10% or more; 7. The affected eye is equipped with an artificial lens made of silicone; 8. A Person with complete loss of visual function (no light perception) in the affected eye or visual acuity of less than 0.05 in the contralateral eye; 9.Persons with corneal clouding that interferes with fundus observation or with corneal endothelial cell counts below 1000/mm2; 10. Those who are unable to maintain the therapeutic position in the postoperative period; 11. Suspected or diagnosed drug addicts; 12. Pregnant or breastfeeding women, those who plan to become pregnant during the trial; 13.Persons with a previous history of allergy to substances such as silicone oil, or allergies (allergy to two or more substances); 14. Persons with severe cardiorespiratory decompensation, hepatic or renal dysfunction (ALT, AST, or Cr > 1.5 times the upper limit of normal values); 15. Participation in a clinical trial of another interventional device within 1 month prior to the conduct of this trial or participation in a clinical trial of a drug within 5 half-lives of the last dose of the drug; 16.Persons who, in the opinion of the investigator, should not participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Abnormal IOP;Retinal Reset Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Macular complete attachment rate;Intraocular pressure;Retinal Reset Rate;Best corrected visual acuity;Performance index; | — |
Countries
China
Contacts
Public ContactXu Xun
Shanghai General Hospital
Outcome results
None listed