OCT Angiography Changes of Retinal Microvasculature After Local Anesthesia in Cases Undergoing Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Macular superficial capillary plexus (SCP) and deep capillary plexus (DCP
研究概览
简要总结
Assessement of retinal microvasculature detected by OCT-angio after peribulbar &retrobulbar anesthesia in cases undergoing cataract surgery .
详细描述
prospective , interventional,comparative , clinical study utilizing a pre-post, within-subject design ,which will be conducted in the Department of Ophthalmology ,Sohag University Hospital ,Egypt.
Optical coherence tomography angiography (OCTA) will be performed before and after the administration of retrobulbar and peribulbar local anesthesia in the same cohort of patients, in order to evaluate the immediate effects of the anesthetic intervention on retinal microvascular parameters.the study will be conducted on patients aged 40-80 years with elective cataract surgery requiring regional block.the study will be divided into two main groups :
- Group with peribulbar anesthesia injection.
- Group with retrobulbar anesthesia injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 40-80 years.
- •patients with elective cataract surgery requiring regional block.
排除标准
- •1.Allergy to study drugs.
- •Media opacities affecting OCT imaging (corneal pathologies, dense cataracts, vitreous.
- •opacities, etc).
- •Patients with any other retinal vascular diseases (retinal vein occlusion, central serous chorioretinopathy, age-related macular degeneration, etc).
- •4. Patients who have had previous intravitreal injections or Laser treatment.
- •Patients who underwent previous vitreoretinal surgeries.
- •Patients with uncontrolled glaucoma or ocular inflammations (eg: vitritis). 7.Patients with diabetes mellitus or hypertension.
研究组 & 干预措施
group A
peribulbar anesthesia injection of two anesthetic agents ( lidocaine 2 %+ hyaluronidase 150IU\ML )
干预措施: Local Anesthesia (peribular injection of both lidocaine 2 % and hyaluronidase 150IU\ML) (Drug)
group A1
peribulbar anesthesia injection ( mepivacaine 2% + hyaluronidase 150IU\ML )
干预措施: Local Anesthesia (peribulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML) (Drug)
group B
retrobulbar anesthesia injection ( lidocaine 2 %+ hyaluronidase 150IU\ML )
干预措施: Local Anesthesia (retrobulbar anesthesia injection of lidocaine 2 % and hyaluronidase 150IU\ML) (Drug)
group B1
retrobulbar anesthesia injection ( mepivacaine 2% + hyaluronidase 150IU\ML )
干预措施: local Anesthesia (retrobulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML) (Drug)
结局指标
主要结局
Macular superficial capillary plexus (SCP) and deep capillary plexus (DCP
时间窗: ntervention & data collection :4-6 monthes
to detect degree of changes in vessel density at superficial and deep macular plexuses before and after injection of each group of anesthesia
次要结局
未报告次要终点
研究者
Amira Aldesoky Ahmed
Principal Investigator
Sohag University