Effects of Intravitreal Bevacizumab Intraoperatively in The Prevention of Early Recurrent Vitreous Hemorrhage Post-Vitrectomy in Diabetic Vitreous Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Incidence and Severity of Vitreal Hemorrhage Post-Operative
研究概览
简要总结
Recurrent vitreous hemorrhage following pars plana vitrectomy (PPV) for proliferative diabetic retinopathy remains a significant complication with reported incidence ranging from 11 to 75%. Early and late recurrences are associated with various factors, including residual blood, fibrovascular tissue, and neovascularization. Despite attempts to reduce this complication with therapies like anti-fibrinolytic agents, gas tamponade, and peripheral cryotherapy, the outcomes remain unsatisfactory.
详细描述
Recurrent vitreous hemorrhage following pars plana vitrectomy (PPV) for proliferative diabetic retinopathy remains a significant challenge with high incidence and negative impact on visual outcomes. Despite various treatments, intravitreal bevacizumab (IVB) has shown potential in reducing post-operative vitreous hemorrhage (PO-VH). This study aims to determine the efficacy and safety of intraoperative IVB in preventing PO-VH in patients undergoing vitrectomy for diabetic vitreous hemorrhage. This prospective, randomized controlled trial compared patients receiving intraoperative IVB to a control group. The primary outcome was PO-VH incidence at one month, with secondary outcomes including visual acuity change, time to VH clearance, and safety. Outcome assessors were masked to the study treatment. Data on demographics, medical history, visual acuity, VH grading, intraoperative findings, and postoperative complications will be collected. Statistical analysis compared PO-VH incidence and other outcomes between groups. This study will provide valuable evidence on the efficacy and safety of intraoperative IVB in preventing PO-VH, contributing to improved clinical practice and patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
While it was not possible to mask participants and surgeons to the treatment allocation due to the nature of the surgical intervention, efforts were made to mask the outcome assessors. This involved:
Centralized Data Collection: All data related to patient outcomes (visual acuity, VH grading, complications) were collected on standardized forms and sent to a central data management center.
Coded Data Entry: Patient identification numbers were used instead of names to prevent bias.
Masked Data Analysis: The statistician conducting the analysis was blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with spontaneous, non-clearing vitreous hemorrhage for at least one month as the initial vitrectomy indication for diabetic retinopathy.
排除标准
- •Patients with tractional retinal detachment (ART)
- •Patients with severe fibrovascular traction,
- •Patients with intravitreal gas or silicone oil tamponade at the end of surgery
- •Patients with other eye diseases besides diabetic vitreous hemorrhage
- •Patients with history of intravitreal bevacizumab injection in the last 3 months before surgery
- •Patients with other health condition includes uncontrolled hypertension, a history of coagulopathy
- •Patients with inability to attend follow-up examinations for at least 1 month
- •Patients taking anti-aggregation and anti-platelet medications with abnormal bleeding time (BT) and clotting time (CT)
研究组 & 干预措施
Bevacizumab Intravitreal
Ten patients underwent pars plana vitrectomy under local anesthesia. Vitrectomy used 3 23-gauge sclerotomies, triamcinolone for hyaloid cleaning, and hemostasis by elevated pressure, endo-diathermy, or laser. Panretinal laser applied to unlasered retina. Retina examined for tears or bleeding. IOP set at 20mmHg, sclerotomies sutured if needed. Post-vitrectomy, 1.25 mg bevacizumab injected via 30-gauge needle in superotemporal or inferotemporal pars plana.
干预措施: Bevacizumab Injection [Avastin] (Drug)
Bevacizumab Intravitreal
Ten patients underwent pars plana vitrectomy under local anesthesia. Vitrectomy used 3 23-gauge sclerotomies, triamcinolone for hyaloid cleaning, and hemostasis by elevated pressure, endo-diathermy, or laser. Panretinal laser applied to unlasered retina. Retina examined for tears or bleeding. IOP set at 20mmHg, sclerotomies sutured if needed. Post-vitrectomy, 1.25 mg bevacizumab injected via 30-gauge needle in superotemporal or inferotemporal pars plana.
干预措施: Pars Plana Vitrectomy (Procedure)
Control
Eight patients underwent pars plana vitrectomy under local anesthesia. Vitrectomy used 3 23-gauge sclerotomies, triamcinolone for hyaloid cleaning, and hemostasis by elevated pressure, endo-diathermy, or laser. Panretinal laser applied to unlasered retina. Retina examined for tears or bleeding. IOP set at 20mmHg, sclerotomies sutured if needed.
干预措施: Pars Plana Vitrectomy (Procedure)
结局指标
主要结局
Incidence and Severity of Vitreal Hemorrhage Post-Operative
时间窗: Day 1, 7, and 30
Calculation of incidence of Vitreal Hemorrhage Post Operative based on grading (Grade 0, Grade 1, Grade 2, Grade 3, Grade 4) between two groups; higher grades are related to worse outcomes
次要结局
- Post operative visual Acuity, compared between groups(Day 1, 7, and 30)