Peripheral Retinal Cryoapplication Versus Anti-VEGF Intravitreal Injection Before Vitrectomy for Complicated Proliferative Diabetic Retinopathy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Intraoperative bleeding
研究概览
简要总结
Pars-plana vitrectomy (PPV) is the cornerstone of surgical treatment for eyes with complicated proliferative diabetic retinopathy. Anti-VEGF intravitreal injection before PPV has shown a good effect on surgical outcomes. However, many patients present with co-morbidities that contraindicate the usage of anti-VEGF in the pre-operative period. Thus, cryoapplication, an old therapeutic tool for proliferative diabetic retinopathy may be a good alternative. The investigators present herein a comparative study between peripheral retinal cryoapplication and anti-VEGF before vitrectomy for complicated proliferative diabetic retinopathy.
详细描述
Pars-plana vitrectomy (PPV) is the cornerstone of surgical treatment of complicated proliferative diabetic retinopathy allowing the removal of vitreous opacity and releasing tractions from the retina. Surgical outcomes, however, are variable depending on a large array of pre, per, and post-operative conditions.
The preoperative anti-VEGF intravitreal injection has shown a good effect on surgical outcomes in patients with vitreous hemorrhage or tractional retinal detachment.
However, a great number of patients present with co-morbidities that contraindicate the usage of anti-VEGF in the pre-operative period.
Thus, an alternative to this adjunctive therapy is worth investigating. In another hand, cryoapplication, an old therapeutic tool for proliferative diabetic retinopathy had been used in patients with non-clear ocular media with vitreous hemorrhage.
The investigators present herein a comparative study between peripheral retinal cryoapplication and anti-VEGF before vitrectomy for complicated proliferative diabetic retinopathy.
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 (Participant)
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
- •Type 1 or 2 diabetes mellitus
- •Vitreous or retro-hyaloidal hemorrhage and/or tractional retinal detachment threatening or involving the macula
- •No or less than 1000 impacts of preoperative retinal photocoagulation and/or iris rubeosis
- •Only one eye per participant
排除标准
- •Negative light perception
- •Previous vitrectomy
- •Contraindication to anti-VEGF therapy or retinal cryoapplication
- •Associated rhegmatogenous retinal detachment
研究组 & 干预措施
Preoperative Anti-VEGF Intravitreal Injection
Three to five days before vitrectomy, each participant received one intravitreal Bevacizumab injection (1.25 mg,0.05 ml).
干预措施: Bevacizumab Injection [Avastin] (Drug)
Peripheral Retinal Cryoapplication
Four to six weeks before vitrectomy, each participant underwent peripheral retinal cryoapplication.
干预措施: Peripheral Retinal Cryoapplication (Procedure)
结局指标
主要结局
Intraoperative bleeding
时间窗: at the end of the vitrectomy
occurrence of intravitreal bleeding during vitrectomy
Total surgical time
时间窗: at the end of the vitrectomy
Duration of vitrectomy from the placement of the trocars until their removal
次要结局
- Postoperative bleeding(one month after the vitrectomy)
- Visual acuity(one month after the vitrectomy)
研究者
Khairallah Moncef
Clinical Professor
University Hospital Fattouma Bourguiba