Wide-Field and Projection-Resolved Optical Coherence Tomography Angiography in Diabetic Retinopathy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Structural OCT Cyst Volume
研究概览
简要总结
Diabetic retinopathy (DR) is a leading cause of vision loss in working-age Americans. Capillary damage from hyperglycemia causes vision loss through downstream effects, such as retinal ischemia, edema, and neovascularization (NV). Proper screening and timely treatment with laser photocoagulation and anti-vascular endothelial growth factor (VEGF) injections can minimize morbidity. In the last decade, clinicians have been able to use objective structural data from optical coherence tomography (OCT) to guide the treatment of diabetic macular edema. Other aspects of care, however, still largely depend on subjective interpretation of clinical features and fluorescein angiography (FA) to determine the disease severity and treatment threshold. The recently developed OCT angiography (OCTA) provides dye-less, injection-free, three-dimensional images of the retinal and choroidal circulation with high capillary contrast. Not only is it safer, faster, and less expensive than conventional dye-based angiography, OCTA provides the potential of giving clinicians objective tools for determining severity of disease by detecting and quantifying NV and non-perfusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •I. All Diabetics (Groups A, B, C)
- •Type 1 diabetes of at least 5 years duration or
- •Type 2 diabetes of any duration II. Group B
- •Able to return for follow-up over 3 years
- •Participant-Related
排除标准
- •Significant medical condition that would make long-term follow-up difficult II. Controls (Group D)
- •Any medical problems associated with retinal vascular abnormalities (i.e., hypertension, systemic vasculitis, carotid insufficiency, etc.)
- •Eye-Related Inclusion Criteria:
- •I. Group A:
- •Presence of active neovascularization, with or without prior treatment
- •Presence of involuted fibrovascular proliferans
- •II. Group B:
- •NPDR of any severity as defined by the International Clinical Diabetic Retinopathy Severity Scale
- •III. Groups C & D:
- •No evidence of diabetic retinopathy
- •IV. Group ME:
- •Presence of center-involving macular edema requiring treatment
- •Eye-Related Exclusion Criteria: (Applies to study eye only. May be present in non-study eye.)
- •Visual acuity worse than 20/200
- •Inability to maintain stable fixation for OCT imaging
- •History of major eye surgery (vitrectomy, cataract surgery, scleral buckle, other intraocular surgery, etc.) within 90 days of enrollment
- •History of another eye disease or condition that may alter retinal perfusion, permeability, or retinal anatomy
- •Substantial media opacity (cataract, corneal scar, vitreous hemorrhage) that may interfere with study imaging
结局指标
主要结局
Structural OCT Cyst Volume
时间窗: 1 year
Cyst volume will be measured in mm3.
PR-OCTA Measure of Non-Perfusion Areas
时间窗: 3 years
Non-perfusion areas of the 3 retinal plexuses and choriocapillaris will be measured in mm2.
Structural OCT Retinal Thickening Area
时间窗: 1 year
The area of retinal thickening will be measured in mm2.
Non-PR-OCTA Retinal Neovascularization Areas
时间窗: 1 year
Retinal neovascularization areas will be measured in mm2.
Non-PR-OCTA Measure of Retinal Non-Perfusion Areas
时间窗: 1 year
Non-perfusion areas of the 3 retinal plexuses will be measured in mm2.
次要结局
未报告次要终点
研究者
David Huang
Thomas Hwang, MD, Associate Professor of Ophthalmology
Oregon Health and Science University