Department of Ophthalmology, Ruijin Hospital, Affiliated Medical School, Shanghai Jiaotong University
试验速览
- 阶段
- 4 期
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- capillary non-perfusion zone of non-proliferative diabetic retinopathy
研究概览
简要总结
Diabetic retinopathy has been found progress in 20-70% diabetic patient after cataract phacoemulsification surgery. Intravitreal injection of anti-VEGF Ranibizumab is an important treatment for diabetic retinopathy including non-proliferative diabetic retinopathy (NPDR). However, there is no research about phacoemulsification surgery combine Intravitreal injection of Ranibizumab on diabetic retinopathy. The research focus on the effect of phacoemulsification surgery combine intravitreal injection of Ranibizumab on mild non-proliferative diabetic retinopathy and explore the reasons for differences in treatment outcomes.
详细描述
This research is a single-center prospective, randomized controlled study. Patient were divided into two groups, the control group is phacoemulsification surgery group and the intervention group is phacoemulsification surgery combine intravitreal injection of Ranibizumab group. Eye examination including visual acuity, intraocular pressure(IOP), fundus fluoroscopy, macular optical coherence tomograph（OCT） examination, were taken before cataract surgery. The anterior aqueous humor was extracted before cataract phacoemulsification in the combined operation group, and 0.05 ml of ranibizumab was injected into the vitreous immediately after the operation. The aqueous humor concentrations of vascular endothelial growth factor（VEGF）, interleukin（IL）IL-2, IL-4, and Tumor Necrosis Factor（TNF） were checked by real-time polymerase chain reaction assay（RT-PCR） and ELISA analysis. The Best Corrected Visual Acuity（BCVA）, IOP and fundus lesions changes were observed in the two groups after operation. Diabetic retinopathy capillary non-perfusion zone were evaluated one year after phacoemulsification surgery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent
- •Commitment to follow the research procedures and cooperate with the implementation of the whole process of research
- •No specific gender, 18+ years old
- •Diagnosed in line with NPDR,
- •Phacoemulsification combined with anti-VEGF therapy is planned
- •No obvious surgical contraindications
排除标准
- •Use of other investigational drug treatments or take part in other types of clinical studies
- •Allergy to anti-VEGF drugs
- •Patients with other macular and optic disc diseases
- •Patients with meaningful diabetic macular edema
- •Patient with surgical complications
研究组 & 干预措施
Cataract phacoemulsification combines Ranibizumab
0.05 ml of ranibizumab was injected into the vitreous immediately after the operation
干预措施: Ranibizumab Injection [Lucentis] (Drug)
Cataract phacoemulsification
0.05 ml of ranibizumab was injected into the vitreous immediately after the operation
干预措施: Ranibizumab Injection [Lucentis] (Drug)
Cataract phacoemulsification
0.05 ml of ranibizumab was injected into the vitreous immediately after the operation
干预措施: Phacoemulsification (Device)
结局指标
主要结局
capillary non-perfusion zone of non-proliferative diabetic retinopathy
时间窗: 1 year
Patient were divided into two groups, the control group is phacoemulsification surgery group and the intervention group is phacoemulsification surgery combine intravitreal injection of Ranibizumab group. Eye examination including visual acuity, intraocular pressure (IOP), fundus fluoroscopy, macular OCT examination, were taken before cataract surgery. The anterior aqueous humor was extracted before cataract phacoemulsification in the combined operation group, and 0.05 ml of ranibizumab was injected into the vitreous immediately after the operation. The BCVA, IOP and fundus lesions changes were observed in the two groups after operation. Diabetic retinopathy capillary non-perfusion zone were evaluated one year after phacoemulsification surgery.
次要结局
- Determination of inflammatory factors in anterior aqueous humor(before cataract phacoemulsification)