Measurement of Total Retinal Blood Flow and Oxygen Extraction in Patients With Diabetes and Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Total retinal blood flow (DVA and FDOCT)
研究概览
简要总结
The prevalence of diabetes and diabetes-associated complications is still increasing. Several major long-term complications of diabetes such as cardiovascular disease, chronic renal failure, diabetic retinopathy and others relate to the damage of blood vessels. Given that the eye provides the unique possibility in the human body to directly visualize blood vessels, much interest has been directed towards studying the ocular circulation and retinal oxygen metabolism.
Although data of large epidemiological studies indicate that changes in retinal vessel caliber reflect other diabetes related factors, such as fasting glucose levels, there is still conflicting evidence on blood flow alterations in patients with diabetes. Strongly related to ocular blood flow, investigation of retinal oxygen metabolism has received a lot attention. In particular, hypoxia is assumed to be major trigger of neovascularisation in the retinal of diabetic patients The present study seeks to investigate both ocular blood flow and tissue oxygen extraction in patients with type II diabetes. For this purpose, total retinal blood flow will be assessed with bi-directional Fourier Domain Doppler Optical Coherence Tomography (FDOCT). Furthermore, retinal oxygen saturation will be measured non-invasively by a fundus camera based system. Based on data of retinal blood flow and retinal oxygen saturation, retinal oxygen. This will help to better understand ocular blood flow changes and oxygen metabolism in patients with type II diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •for healthy subjects:
- •Men and women aged over 18 years
- •Non-smokers
- •Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- •Normal ophthalmic findings, ametropy < 6 Dpt.
- •Inclusion criteria for patients with diabetes
- •Men and women aged over 18 years
- •Non-smokers
- •Previously diagnosed type II diabetes
- •No, mild, moderate or severe non-proliferative diabetic retinopathy
- •Normal ophthalmic findings except mild diabetic retinopathy, ametropy < 6 Dpt.
排除标准
- •for healthy subjects:
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •Presence or history of a severe medical condition as judged by the clinical investigator
- •Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptive)
- •untreated arterial hypertension (defined as either systolic blood pressure >145 mmHg or diastolic blood pressure >90 mmHg)
- •Blood donation during the previous three weeks
- •History or family history of epilepsy
- •Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
- •Best corrected visual acuity < 0.8 Snellen
- •Ametropy ≥ 6 Dpt
- •Pregnancy, planned pregnancy or lactating
- •Exclusion Criteria for patients with diabetes:
- •Participation in a clinical trial in the 3 weeks preceding the screening visit
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •Presence or history of a severe medical condition, except diabetes, as judged by the clinical investigator
- •untreated arterial hypertension (defined as either systolic blood pressure >145 mmHg or diastolic blood pressure >90 mmHg)
- •Blood donation during the previous three weeks
- •Moderate to severe non-proliferative or proliferative diabetic retinopathy
- •Previous laser photocoagulation treatment
- •History or family history of epilepsy
- •Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
- •Best corrected visual acuity < 0.8 Snellen
- •Ametropy ≥ 6 Dpt
- •Pregnancy, planned pregnancy or lactating
研究组 & 干预措施
30 patients with no signs of diabetic retinopathy
干预措施: Fourier Domain Color Doppler Optical Coherence Tomography (FDOCT) (Device)
30 patients with mild diabetic retinopathy
干预措施: Fourier Domain Color Doppler Optical Coherence Tomography (FDOCT) (Device)
30 patients with moderate to severe diabetic retinopathy
干预措施: Fourier Domain Color Doppler Optical Coherence Tomography (FDOCT) (Device)
30 healthy age-and sex- matched control subjects
干预措施: Fourier Domain Color Doppler Optical Coherence Tomography (FDOCT) (Device)
结局指标
主要结局
Total retinal blood flow (DVA and FDOCT)
时间窗: 60 minutes
To determine the total blood flow in the eye, OCT measurements were performed with a rectangular scanning pattern around the optical nerve head.
次要结局
未报告次要终点
研究者
Gerhard Garhofer
Assoc. Prof. Priv.-Doz. Dr.
Medical University of Vienna