Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,050
- 试验地点
- 1
- 主要终点
- Correlation of Imaging
研究概览
简要总结
This study will perform a prospective, longitudinal analysis of clinical and imaging findings from normal controls and subjects with retinal vascular disease to better define the diagnostic imaging criteria that signify change in disease stage. This includes disease progression in early stages of disease or disease regression with appropriate standard-of-care treatment.
详细描述
The objective of this study is to perform a prospective, longitudinal analysis of clinical and imaging findings from normal controls and subjects with retinal vascular disease to better define the diagnostic imaging criteria that signify change in disease stage. This includes disease progression in early stages of disease or disease regression with appropriate standard-of-care treatment.
Subjects will be identified from healthy subjects (seen for screening eye exams) and diseased subjects undergoing standard-of-care treatment or screening at eye clinic locations. The study population will include subjects with retinal vascular disease including but not limited to diabetic retinopathy, hypertension, retinal vein/arterial occlusion, and macular degeneration. Subjects who are enrolled will undergo non-invasive, minimal risk, FDA approved diagnostic imaging procedures to identify vascular changes.
The study methods will include retrospective review and collection of clinically approved imaging data that is obtained through standard-of-care methods for subjects who meet inclusion and exclusion criteria. Subjects who are identified in this manner will be asked to participate in a prospective study by each clinical study site.
The study end-points include the correlation of diagnostic imaging findings from Optical Coherence Tomography (OCT) based images with fundus photographs, clinical disease stage and visual acuity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Exclusion Criteria:
- •Both subjects with diseases and controls:
- •Children (age<18)
- •Pregnant females
- •Developmentally delayed subjects
- •Subjects unable to provide informed consent
- •Inability to cooperate with tests and study instructions
- •Images with motion artifact or signal strength < 7
- •History of glaucoma
- •History of age-related macular degeneration
- •History of any visually significant eye disease
- •History of proliferative diabetic retinopathy
- •History of any inflammatory disease
- •History of heart disease
- •History of thyroid disease.
- •Additional criteria for controls:
- •History of any type of Diabetes Mellitus
- •History of any type of Hypertension
排除标准
- •Both subjects with diseases and controls:
- •Children (age<18)
- •Pregnant females
- •Developmentally delayed subjects
- •Subjects unable to provide informed consent
- •Inability to cooperate with tests and study instructions
- •Images with motion artifact or signal strength < 7
- •History of glaucoma
- •History of age-related macular degeneration
- •History of any visually significant eye disease
- •History of proliferative diabetic retinopathy
- •History of any inflammatory disease
- •History of heart disease
- •History of thyroid disease.
- •Additional criteria for controls:
- •History of any type of Diabetes Mellitus
- •History of any type of Hypertension
研究组 & 干预措施
Controls
Subjects in this group do not have any ocular pathology and are also not hypertensive. Some subjects in this arm will undergo retinal vascular reactivity assessments.
干预措施: Swept-Source (SS) OCT Angiography (Device)
Controls
Subjects in this group do not have any ocular pathology and are also not hypertensive. Some subjects in this arm will undergo retinal vascular reactivity assessments.
干预措施: Spectral-Domain (SD) OCT Angiography (Device)
Diabetics w/ or w/o Diabetic Retinopathy & Hypertension
Subjects in this group have diabetes with or without diabetic retinopathy and hypertension with or without ocular pathology related to hypertension. Some subjects in this arm may undergo retinal vascular reactivity assessments.
干预措施: Fundus Imaging (Device)
Diabetics w/ or w/o Diabetic Retinopathy & Hypertension
Subjects in this group have diabetes with or without diabetic retinopathy and hypertension with or without ocular pathology related to hypertension. Some subjects in this arm may undergo retinal vascular reactivity assessments.
干预措施: Spectral-Domain (SD) OCT Angiography (Device)
Diabetics w/ or w/o Diabetic Retinopathy & Hypertension
Subjects in this group have diabetes with or without diabetic retinopathy and hypertension with or without ocular pathology related to hypertension. Some subjects in this arm may undergo retinal vascular reactivity assessments.
干预措施: Axial Length Measurement Device (Device)
Controls
Subjects in this group do not have any ocular pathology and are also not hypertensive. Some subjects in this arm will undergo retinal vascular reactivity assessments.
干预措施: Axial Length Measurement Device (Device)
Controls
Subjects in this group do not have any ocular pathology and are also not hypertensive. Some subjects in this arm will undergo retinal vascular reactivity assessments.
干预措施: Fundus Imaging (Device)
Diabetics with and without Diabetic Retinopathy Only
Subjects in this group only have diabetes with or without diabetic retinopathy. Some subjects in this arm will undergo retinal vascular reactivity assessments.
干预措施: Swept-Source (SS) OCT Angiography (Device)
Diabetics with and without Diabetic Retinopathy Only
Subjects in this group only have diabetes with or without diabetic retinopathy. Some subjects in this arm will undergo retinal vascular reactivity assessments.
干预措施: Spectral-Domain (SD) OCT Angiography (Device)
Diabetics with and without Diabetic Retinopathy Only
Subjects in this group only have diabetes with or without diabetic retinopathy. Some subjects in this arm will undergo retinal vascular reactivity assessments.
干预措施: Fundus Imaging (Device)
Diabetics with and without Diabetic Retinopathy Only
Subjects in this group only have diabetes with or without diabetic retinopathy. Some subjects in this arm will undergo retinal vascular reactivity assessments.
干预措施: Axial Length Measurement Device (Device)
Hypertension Only
Subjects in this group only have hypertension with or without ocular pathology related to hypertension. Some subjects in this arm may undergo retinal vascular reactivity assessments.
干预措施: Swept-Source (SS) OCT Angiography (Device)
Hypertension Only
Subjects in this group only have hypertension with or without ocular pathology related to hypertension. Some subjects in this arm may undergo retinal vascular reactivity assessments.
干预措施: Spectral-Domain (SD) OCT Angiography (Device)
Hypertension Only
Subjects in this group only have hypertension with or without ocular pathology related to hypertension. Some subjects in this arm may undergo retinal vascular reactivity assessments.
干预措施: Fundus Imaging (Device)
Hypertension Only
Subjects in this group only have hypertension with or without ocular pathology related to hypertension. Some subjects in this arm may undergo retinal vascular reactivity assessments.
干预措施: Axial Length Measurement Device (Device)
Diabetics w/ or w/o Diabetic Retinopathy & Hypertension
Subjects in this group have diabetes with or without diabetic retinopathy and hypertension with or without ocular pathology related to hypertension. Some subjects in this arm may undergo retinal vascular reactivity assessments.
干预措施: Swept-Source (SS) OCT Angiography (Device)
结局指标
主要结局
Correlation of Imaging
时间窗: 5 years
Correlation of diagnostic imaging findings (vessel skeleton density) from OCT based images with disease stage
次要结局
未报告次要终点