Evaluating the Retinal and Choroidal Microvasculature and Structure Using Multimodal Retinal and Choroidal Imaging in Neurodegenerative Disease: iMIND Research Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Change in retinal nerve fiber layer (RNFL) thickness
研究概览
简要总结
This study aims to develop and evaluate biomarkers using non-invasive optical coherence tomography (OCT) and OCT angiography (OCTA) as well as ultra-widefield (UWF) fundus photography to assess the structure and function of the retinal and choroidal microvasculature and structure in persons with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), Parkinson's Disease (PD), or other neurodegenerative disease, diseases as outlined.
详细描述
Using a multidisciplinary approach, this study aims to yield new insight into the vascular and structural pathophysiology of neurodegenerative disease. The investigators propose to develop and evaluate imaging biomarkers from OCT, OCTA, and UWF fundus photos to assess the structure and function of the retinal and choroidal microvasculature and structure in these individuals.
The investigators hypothesize that microvascular and structural network alterations in the retina and choroid may mirror and possibly precede changes in the cerebral microcirculation seen in these neurodegenerative diseases. Using advanced image analysis and machine learning techniques, the investigators aim to evaluate markers of reduced capillary blood flow and non-perfusion in the superficial retinal vascular plexus and choriocapillaris imaged using OCT and OCTA, in a resolution not previously possible, that would complement already established retinal structural markers and increase their sensitivity and specificity in the earlier detection of these neurodegenerative diseases.
This study looks to provide a proof of concept for retinal and choroidal imaging-based microvascular and structural biomarkers as an effective screening tool for neurodegenerative disease, particularly during in cognitive aging.
The protocol for this study was amended and the record was updated accordingly.
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
- •Adults with neurodegenerative disease ((MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome)
- •Adults without neurodegenerative disease
排除标准
- •Inability to cooperate with or complete testing or other neurologic or age- related ocular conditions that would impact image acquisition.
- •Eyes that have had intraocular surgery, other than cataract surgery.
- •If two eyes satisfy the inclusion criteria, both eyes will be included in the study. If one eye satisfies the inclusion criteria, the eye that qualifies will be included in the study.
研究组 & 干预措施
Case
Patients with (MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome)
干预措施: Retinal and Choroidal Imaging (Device)
Controls
Controls will be recruited from the relatives/attendants of study participants or will be patients themselves and will not have a neurodegenerative disease diagnosis.
干预措施: Retinal and Choroidal Imaging (Device)
结局指标
主要结局
Change in retinal nerve fiber layer (RNFL) thickness
时间窗: Baseline, 1 year
Retinal nerve fiber layer thickness as measured on optical coherence tomography scan of macula
Change in central subfield thickness (CST)
时间窗: Baseline, 1 year
Central subfield thickness as measured on optical coherence tomography scan of macula
Change in choroidal vascularity index (CVI)
时间窗: Baseline, 1 year
Choroidal vascularity index as measured using the COIN software in 1500 um area centered on the fovea
Change in foveal avascular zone (FAZ) area
时间窗: Baseline, 1 year
Foveal avascular zone area as measured in the superficial capillary plexus on 3mm optical coherence tomography angiography scan of the macula
Change in average vessel density (VD)
时间窗: Baseline, 1 year
Average vessel density as measured in the ETDRS 3mm and 6mm circle and rings on optical coherence tomography angiography scan of the macula
Change in average capillary perfusion density (CPD)
时间窗: Baseline, 1 year
Capillary perfusion density as measured on peripapillary 4.5mm optical coherence tomography angiography scan
Change in ganglion cell-inner plexiform layer (GCIPL) thickness
时间窗: Baseline, 1 year
Ganglion cell inner plexiform layer thickness as measured on optical coherence tomography scan of macula
Change in average perfusion density (PD)
时间窗: Baseline, 1 year
Average perfusion density as measured in the ETDRS 3mm and 6mm circle and rings on optical coherence tomography angiography scan of the macula
Change in average capillary flux index (CFI)
时间窗: Baseline, 1 year
Capillary flux index as measured on peripapillary 4.5mm optical coherence tomography angiography scan
次要结局
- Change in retinal vessel width gradient(Baseline, 1 year)
- Change in retinal vessel tortuosity(Baseline, 1 year)
- Change in retinal vessel fractal dimension(Baseline, 1 year)