Diabetic retinopathy
Conditions
Interventions
Experimental group:10K 25G+ probes vitrectomy
Control group:7.5K 25G+ probes vitrectomy
Sponsors
Shandong Eye Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form; 2. 18 = age = 80 years old, gender is not limited; 3. Diagnosed with type 1 or type 2 diabetes mellitus; 4. Glycosylated hemoglobin (HbA1c) value = 11%; 5. Injection of anti-VEGF drugs within 4-7 days prior to surgery 6. The study eye must meet the following requirements: (1) patients with severe proliferative diabetic retinopathy requiring vitrectomy due to fundus examination or ultrasound findings in combination with traction retinal detachment (2) ETDRS visual acuity scale with BCVA = light perception and = 78 letters (equivalent to LP to 20/32 on the Snellen scale); 7.Diabetic retinopathy requiring vitrectomy in both eyes, including the eye with slightly better vision.
Exclusion criteria
Exclusion criteria: Study Eye: 1. have an active intraocular or periocular infection or active intraocular inflammation at the time of screening (e.g., infected blepharitis, infected conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis, etc.) 2. have uncontrolled glaucoma (defined as intraocular pressure =25 mmHg despite treatment with anti-glaucoma medications), or severe glaucoma causing a cup/disc ratio >0.8 in the study eye, or the study eye has undergone glaucoma filtration; or have iris neovascularization in the study eye; 3. have a history of vitrectomy; 4. History of optic neuropathy 5. history of any intraocular surgery (e.g., cataract surgery, YAG posterior capsulotomy, etc.) excluding history of vitreous cavity injections of anti-VEGF medications within 1 month prior to screening; Non-study eyes: 6. non-study eye with loss of function, defined as: manual or worse BCVA; absence of non-study eye (i.e., monocular) Any of the following systemic conditions: 7. suboptimal blood pressure control (defined as systolic blood pressure >=160 mmHg or diastolic blood pressure =110 mmHg after treatment with antihypertensive medications); 8. current systemic infection requiring oral, intramuscular, or intravenous administration of medication 9. History of stroke (except lacunar infarction without clinical symptoms), history of myocardial infarction and/or cerebrovascular disease, history of transient cerebral ischemia within 6 months prior to the screening, as well as active diffuse intravascular coagulation and obvious bleeding tendency; 10. are using drugs that are toxic to the lens, retina, or optic nerve (e.g., desferrioxamine, chloroquine, hydroxychloroquine (chloroquine), triamcinolone acetonide/taximophen, phenothiazines, or ethambutol, etc.); and 11. Patients with confirmed systemic immune diseases (e.g., ankylosing spondylitis, systemic lupus erythematosus, etc.) or any uncontrolled clinical problems (e.g., AIDS, malignant tumors, active hepatitis, severe psychiatric, neurological, cardiovascular, respiratory, and other systemic diseases, etc.); 12. have a history of allergy to any investigational drug or its excipients or drugs of a similar chemical class, or a clinically significant sensitivity to fluorescein dyes as assessed by the investigator; 13. Abnormalities in any of the following laboratory tests: impaired renal function (serum creatinine greater than 1.5 times the upper limit of normal in the Center's laboratory) or abnormal hepatic function (ALT or AST greater than 2 times the upper limit of normal in the Center's laboratory); abnormalities in coagulation (prothrombin time 2 3 seconds above the upper limit of normal, activated partial thromboplastin time = 10 seconds above the upper limit of normal). Male or female patients of childbearing age with any of the following conditions: 14. not using effective contraception; Note: the following are not excluded: amenorrhea for 12 months in the absence of albumin: 6 weeks after bilateral salpingo-oophorectomy combined with/without hysterectomy; use of one or more of the following acceptable methods of contraception: sterilization (bilateral vasectomy, resection for male partners) hormonal contraception (implantable, patch, oral) intrauterine device (IUD), double-barrier method; ability to use reliable contraception for the entire study period Reliable contraceptive use throughout the study period and until the end of the visit (unacceptable contraceptive methods are: regular abstinenc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comprehensive vitrectomy time ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Vitrectomy Surgery Time;Number of instrument exchanges through ports during vitrectomy;Number of retinal tears of medical origin;Best corrected visual acuity;Intraocular pressure; | — |
Countries
China
Contacts
Public ContactGongqiang Yuan
Shandong Eye Hospital
Outcome results
None listed