Methods
PDR, myocardial infarction, liver or kidney dysfunction, diabetes mellitus, tractional retinal detachment, Diabetic Retinopathy, tamponade, postvitrectomy, choroidal or retinal disease, cerebrovascular accident, IOL, hypertension, T2DM, coagulation mechanism disorder
SYSTEMIC DISEASE, DIABETES MELLITUS, RETINAL TEAR, DIABETIC RETINOPATHY, EVENTS, INTRAOPERATIVE BLEEDING, POSTOPERATIVE COMPLICATIONS, PROLIFERATION, EYE, TRACTIONAL RETINAL DETACHMENT, IOL, LENS, TYPE 2 DIABETES MELLITUS, COMPLICATIONS, INTRAOCULAR PRESSURE, MYOCARDIAL INFARCTION, CEREBROVASCULAR ACCIDENT, NEOVASCULARIZATION, HYPERTENSION
This was a prospective, randomized clinical trial (NCT 05478967). The study followed the tenets of the Declaration of Helsinki and was approved by the Institutional Review Board of the Peking University People's Hospital. Written informed consent was signed by all participants before enrollment.The present study enrolled patients with PDR at the Department of Ophthalmology, Xiamen Eye Center of Xiamen University, between August 2019 and March 2021. The inclusion criteria were as follows: (1) patients with type 2 diabetes mellitus (T2DM), (2) patients aged between 35 and 65 years, and (3) patients with PDR who underwent primary pars plana vitrectomy (PPV) for VH. The following cases were excluded from analysis: (1) eyes with retinal tear, (2) eyes with iris or anterior angle neovascularization, (3) eyes with intraoperative use of silicone oil, (4) eyes with choroidal or retinal disease other than PDR or any inflammatory condition, (5) eyes that underwent any previous vitrectomy or scleral buckle surgery, (6) eyes that received intraocular triamcinolone acetonide (TA) injection within 90 days before screening, (7) eyes that received intraocular anti-VEGF treatment within 60 days before screening or contralateral eyes received intraocular anti-VEGF treatment during follow-up, (8) patients who had taken aspirin orally within 7 days before screening, (9) patients who had coagulation mechanism disorder or had taken any other medicine for anticoagulant treatment, (10) patients who had cerebrovascular accident and/or myocardial infarction occurring within 180 days before screening, (11) patients with uncontrolled blood pressure (sitting position > 160/100 mmHg), (12) patients with liver or kidney dysfunction or any severe systemic disease, and (13) patients who accepted any anti-VEGF therapy for the study eye during the follow-up. If both eyes of the same patients were eligible, the eye with worse vision was included in the study.The enrolled eyes were randomly assigned, according to the Central Randomization System, with a ratio of 1:1 to the IVA group and the control group. Patients in the IVA group received an IVA (0.5 mg/0.05 ml) injection before surgery (1 to 5 days before surgery); patients in the control group did not receive IVA injection before vitrectomy. The preoperative IVA injection was given following a standard protocol. All patients underwent 25-gauge transconjunctival sutureless vitrectomy using the 25-gauge trocar and cannula system under local anesthesia. Procedures, such as fibrovascular membrane dissection, endodiathermy, or endolaser photocoagulation, were performed with 25-gauge instruments, as required. Pan-retinal photocoagulation (PRP) was complicated as much as possible during the surgery. Intraoperative bleeding was controlled either by endodiathermy or by increasing the irrigation pressure.Patients were examined 1 week, 1 month, 2 months, and 3 months after surgery if there were no postoperative events. If postoperative complications, including VH, occurred, patients were instructed to visit the clinic, regardless of the visit schedule. At each visit, any events involving the study eye between the visit schedules were recorded accordingly. At each postoperative visit, slit-lamp biomicroscopy, indirect ophthalmoscopy, and fundus photography were performed.The primary outcome was the incidence of VH at 1 month after PPV. Secondary outcome measures were best-corrected visual acuity (BCVA) changes from baseline at 1 week, 1 month, 2 months, and 3 months after surgery. Preoperative, intraoperative, and postoperative data were collected for each patient. Preoperative data included age, sex, duration, and status of diabetes mellitus [hemoglobin A1c (HbA1c)]; the presence of other systemic diseases such as hypertension and renal function (serum creatinine); and ophthalmic parameters including best-corrected visual acuity (BCVA), intraocular pressure (IOP), lens status, previous PRP, and indication for surgery. Intraoperative data included phacoemulsification and intraocular lens (IOL) procedures, sulfur hexafluoride (SF6) or air tamponade, and the presence of fibrovascular proliferation and tractional retinal detachment. Postoperative data included BCVA at each visit and the number of episodes of complications. Postoperative VH was defined as a new episode of VH of grade 1 or above, occurring later than 3 days after the primary surgery and was evaluated according to the Diabetic Retinopathy Vitrectomy Study grading system. Incidences of VH at week 1, month 1, month 2, and month 3 were recorded. In the case of a gas-injected eye, complications were assessed in the region without the gas bubble. Outcome assessors were masked from the allocation of each study eye.The present study compared baseline clinical data and postvitrectomy complications between the IVA group and the control group in patients with PDR. The chi-square test and the Mann–Whitney test were used. A 