Comparative Study Between Intravitreal Injection of Ranibizumab with and Without Prior Anterior Chamber Paracentesis in Patients with Diabetic Macular Oedema Using Optical Coherence Tomography Angiography [OCT-A]
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- the acute change in angiographic parameters
研究概览
简要总结
The goal of this clinical trial is to to evaluate the changes in retinal microvasculature secondary to intra-ocular pressure changes post intra-vitreal injection in patients with diabetic macular oedema highlighting the effect of prior anterior chamber paracentesis on such changes if present .
The main question[s]it aims to answer are:
•[is there any effect of post intra-vitreal injection IOP spikes on retinal microvasculature?] •[is there any effect of Prior Anterior Chamber Paracentesis?] Participants in group A will be subjected to an identified approved treatment( intra-vitreal injection)& Participants in group B will be subjected to a prior ACP with the intra-vitreal injection . ]
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diabetes mellitus type II.
- •Patients with visual acuity > 0.1, able to fixate and with clear visual media.
- •Patients with eyes with non ischemic diffuse center involving DME were randomly assigned to receive IVI of ranibizumab either without (group A) or with (group B) ACP.
排除标准
- •Age under 40 years.
- •Poorly controlled diabetics (HbA1C greater than 9.0%)
- •Proliferative diabetic retinopathy.
- •OCT-Angiographic evidence of ischemia (enlarged foveal avascular zone, paramacular areas of capillary nonperfusion)
- •Neovascular AMD in the study eye.
- •History of glaucoma.
- •Tilted disc and optic disc anomalies.
- •One-eyed patients.
- •Usage of systemic or topical corticosteroids.
- •Patients with a history of intraocular surgery other than cataract surgery.
- •Systemc diseases rather than hypertension and diabetes mellitus.
- •Corneal opacities that might hinder acquisition of good quality OCT images.
研究组 & 干预措施
Group A
Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab without Anterior Chamber Paracentesis.
干预措施: intra-vitreal injection of Ranibizumab (Drug)
Group B
Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab with Anterior Chamber Paracentesis.
干预措施: intra-vitreal injection of Ranibizumab (Drug)
Group B
Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab with Anterior Chamber Paracentesis.
干预措施: anterior chamber paracentesis (Procedure)
结局指标
主要结局
the acute change in angiographic parameters
时间窗: 1 day
OCTA of macula and peripapillary region with documentation of vessel density
次要结局
- the acute change in intra-ocular pressure(1 day)
研究者
Amr Sanad
Assistant lecturer of ophthalmology
Ain Shams University