The in Vivo Effect of Medical and Surgical Glaucoma Treatments on the Schlemm's Canal
试验速览
- 阶段
- 不适用
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Mean SC (schlemm's canal) cross-sectional area and volume
研究概览
简要总结
The purpose of our current series of studies is to evaluate different glaucoma treatments in vivo effect on the conventional outflow pathway, and specifically on the Schlemm's canal (SC) anatomy using Enhanced Depth Imaging (EDI)-optical coherence tomography (OCT) . The images will be taken as part of the patients routine medical follow up (before starting the treatment, and 1,4 and 12 weeks afterwards) diameter, cross-sectional area and volume will be measured using commercially available 3-dimensional reconstruction.
The series of studies will be divided into 3 branches, each branch contains different treatments.For each treatment different patients will be recruited.
The branches are as following-
-
The surgical branch-
-
Before and after trabeculotomy
-
Before and after cataract surgery
-
Before and after vitrectomy surgery
-
Before and after XEN™ Gel Stent implant
-
The pharmacological branch-
-
Before and during the treatment with prostaglandins analogs
-
Before and during the treatment with alpha blockers
-
Before and during the treatment with beta blockers
-
Before and during the treatment with carbonic anhydrase inhibitor
-
The laser branch-
-
Before and after trabeculoplasty
-
Before and after laser iridotomy
-
Before and after yag capsulotomy laser
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female of any race, at least 18 years of age.
- •Has provided verbal and written informed consent.
- •Able and willing to follow instructions, including participation in all study assessments and visits.
- •Has been referred to one of the treatments mentioned
排除标准
- •Has history of ocular conditions that may affect the SC structure (e.g., ocular neovascularization, anterior segment congenital anomalies)
- •Subject uncooperativeness that restricts adequate examination of IOP, ocular fundus or
- •any ocular or systemic conditions that may reduce OCT image quality (e.g., severe dry eye syndrome, visually significant cataract, limbal opacities, nystagmus, Parkinsonism, etc),
- •Pregnant women or male or female younger than 18 years of age
研究组 & 干预措施
OCT imaging of surgical/pharmacological/laser branch
to evaluate the effect on the conventional outflow pathway, and specifically on the Schlemm's canal (SC) anatomy in the surgical branch:
- Before and after trabeculotomy
- Before and after cataract surgery
- Before and after vitrectomy surgery
- Before and after XEN™ Gel Stent implant
pharmacological branch-
- Before and during the treatment with prostaglandins analogs
- Before and during the treatment with alpha blockers
- Before and during the treatment with beta blockers
- Before and during the treatment with carbonic anhydrase inhibitor
laser branch-
- Before and after trabeculoplasty
- Before and after laser iridotomy
- Before and after yag capsulotomy laser
干预措施: Optical coherence tomography imaging (Device)
结局指标
主要结局
Mean SC (schlemm's canal) cross-sectional area and volume
时间窗: 1 year
次要结局
- Correlation of changes with intraocular pressure (IOP) reduction(1 year)