Clinical Applications of Advanced Ophthalmic Imaging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- Retinal vasculature by optical coherence tomography angiography (OCTA)
研究概览
简要总结
The purpose of this study is to determine the clinical application of advanced ophthalmic imaging devices such as optical coherence tomography (OCT), retinal function imager (RFI), slit-lamp biomicroscopy (SLB), PERG in diseased eyes and normal controls.
There are two phases in this study. The first phase is an observational phase which studies the eye in various conditions. The second phase is an interventional phase which studies the changes in the eyes after taking an over-the-counter medical food (Ocufolin) for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Observational Phase 1 Group
- •Inclusion Criteria:
- •Self-reported normal healthy subjects;
- •Clinical diagnosis of Alzheimer's Disease, mild cognitive impairment, multiple sclerosis, dry eye, myopia, diabetics and stroke;
- •Who can keep the eye open for imaging.
排除标准
- •who can not read and sign the ICF;
- •who can not receiving ophthalmic imaging;
- •who cannot tolerate bright light during imaging.
- •Interventional Phase 2 Group:
- •Inclusion criteria
- •The participant will be eligible for entry in the study if s/he:
- •Is at least 18 years old and has full legal capacity to volunteer;
- •Has read and signed the IRB Informed Consent Document;
- •Is willing and able to follow participant instructions;
- •Has clear corneas and crystalline lens;
- •Initial visual acuities were 20/80 or better;
- •MTHFR C677TT homozygous, or MTHFR C677T/A1298C compound heterozygous with mild to moderate micro-aneurismal vascular retinopathy disease;
- •Hemoglobin A1c is 10 or less;
- •Normotensive with or without medications;
- •Without retinal capillary dropout or macular edema;
- •Blood homocysteine >
- •Exclusion criteria
- •The subjects will be ineligible for entry into the study if s/he:
- •Has an active ocular disease;
- •Has had surgery or an eye injury within 6 months.
研究组 & 干预措施
Interventional Phase - Ocufolin Group
Participants in this group will receive the Ocufolin medical food for 6 months.
干预措施: Ocufolin (Dietary Supplement)
Observational Phase Group
Participants in this group will be studied and followed up for 1-2 years.
结局指标
主要结局
Retinal vasculature by optical coherence tomography angiography (OCTA)
时间窗: up to 2 years
Retinal vascular network density in percentage.
Conjunctival vasculature by functional slit-lamp (FSLB)
时间窗: up to 2 years
Conjunctival vascular network density in percentage.
Retinal microstructure using OCT.
时间窗: up to 2 years
Optical coherence tomography is used to measure the thickness of intraretinal layers. The measurement is in micrometer.
Tear film thickness
时间窗: up to 2 years
Measured in micrometers using ultra high resolution OCT
Corneal epithelial thickness
时间窗: up to 2 years
Measured in micrometers using ultra high resolution OCT
次要结局
- Conjunctival blood flow velocity by functional slit-lamp (FSLB)(up to 2 years)
- Retinal blood flow velocity by retinal function imager (RFI)(up to 2 years)
研究者
Jianhua (Jay) Wang, MD, PhD
Professor
University of Miami