Status:
COMPLETED
Measurement of Total Retinal Blood Flow in Patients With Diabetes and Healthy Subjects
Lead Sponsor:
Medical University of Vienna
Conditions:
Type I Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria 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, ametropia \< 6 Dpt.
- Inclusion criteria for patients with diabetes
- Men and women aged over 18 years
- Non-smokers
- Previously diagnosed type I diabetes
- No or mild non-proliferative diabetic retinopathy
- Normal ophthalmic findings except mild diabetic retinopathy, ametropia \< 6 Dpt.
Exclusion
- Any of the following will exclude a healthy subject from the study:
- 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)
- Arterial hypertension (defined as either systolic blood pressure \>145 mmHg or diastolic blood pressure \>90 mmHg)
- Blood donation during the previous three weeks
- Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
- Best corrected visual acuity \< 0.8 Snellen
- Ametropia \>= 6 Dpt
- Pregnancy, planned pregnancy or lactating
- Any of the following will exclude a patient with diabetes from the study:
- 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
- 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
- Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
- Best corrected visual acuity \< 0.8 Snellen
- Ametropia \>= 6 Dpt
- Pregnancy, planned pregnancy or lactating
Key Trial Info
Start Date :
January 12 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01843114
Start Date
January 12 2015
End Date
March 1 2017
Last Update
March 21 2017
Active Locations (1)
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1
Department of Clinical Pharmacology
Vienna, Vienna, Austria, 1090