Suprachoroidal Injection of Triamcinolone Acetonide Using Custom Made Needle to Treat Macular Diseases and Non Infectious Posterior Uveitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Proportion of patients achieved visual acuity improvement
研究概览
简要总结
Injection in the Suprachoroidal space has potential of increasing the efficacy of the drug upto six times with direct effect on retinal tissues sparing the crystalline lens and trabecular meshwork.
详细描述
A custom made 30 gauge needle offering 1000 micron penetration of the sclera at the parsplana with the help of gentle pressure on the sclera will help to inject medication such as triamcinilone or VEGF blockade agents (Ziv aflibercept or Bevacizumab) in the potential Suprachoroidal space which offers direct effect of injected drug on the retina and choroid sparing both crystalline lens, trabecular meshwork and other ocular tissues, hence improving efficacy of the drug upto six times and reduce potential complications such as cataract and glaucoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years and older
- •Patients with macular edema or degeneration from various pathologies
- •Central macular thickness more than 250 microns
- •Patients who are able to come for all follow-up
排除标准
- •Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- •Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
- •For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
- •Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis
研究组 & 干预措施
A custom made Suprachoroidal needle for macular diseases
A custom made 30 gauge needle offering 1000 micron penetration of the sclera at the parsplana
干预措施: Custom suorachoroidal needle (Procedure)
结局指标
主要结局
Proportion of patients achieved visual acuity improvement
时间窗: 12 weeks
To measure best corrected visual acuity using using Snellen chart or equivalent
次要结局
- Amount of Central macular thickness reduction in microns(12 weeks)
- Proportion of eyes with Increased intraocular pressure(12 weeks)
研究者
Ameen Marashi
Principle investigator
Marashi Eye Clinic