Back to resultsMeasurement of Total Retinal Blood Flow in Patients With Diabetes and Healthy Subjects
Primary Purpose
Type I Diabetes
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
FDOCT
Dynamic Vessel Analyzer
Sponsored by
About this trial
This is an interventional basic science trial for Type I Diabetes focused on measuring Retinal blood flow, Retinal vessel diameter, Fourier Domain Optical Coherence Tomography, Retinal blood velocities
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Sites / Locations
- Department of Clinical Pharmacology
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patients with Type I Diabetes
Healthy subjects
Arm Description
24 patients with type I diabetes with no or mild non-proliferative retinopathy
24 healthy age-and sex- matched control subjects
Outcomes
Primary Outcome Measures
Total retinal blood flow
Measurement of total retinal blood flow using the Dynamic Vessel Analyzer and Optical Coherence Tomography
Secondary Outcome Measures
Retinal vessel diameter
Measurement of retinal vessel diameter using the Dynamic Vessel Analyzer
Retinal blood velocities
Measurement of retinal blood flow velocities using Fourier Domain Optical Coherence Tomography
Full Information
NCT ID
NCT01843114
First Posted
April 26, 2013
Last Updated
March 17, 2017
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT01843114
Brief Title
Measurement of Total Retinal Blood Flow in Patients With Diabetes and Healthy Subjects
Official Title
Measurement of Total Retinal Blood Flow in Patients With Diabetes and Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 12, 2015 (Actual)
Primary Completion Date
August 26, 2016 (Actual)
Study Completion Date
March 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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. 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. This is also related to the fact that up to now, methodological difficulties aggravate the assessment of blood flow changes in the retina in larger groups of patients. In the present study we propose to overcome this problem by using a technique called bi-directional Fourier Domain Doppler Optical Coherence Tomography (FDOCT), which we have developed in the recent years to measure retinal blood velocities. This technique allows for the non-invasive investigation of blood flow changes in human retina and will help us to better understand diabetes related vascular changes. The present study will use this technique to assess retinal blood flow changes in patients with diabetes and healthy subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type I Diabetes
Keywords
Retinal blood flow, Retinal vessel diameter, Fourier Domain Optical Coherence Tomography, Retinal blood velocities
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with Type I Diabetes
Arm Type
Other
Arm Description
24 patients with type I diabetes with no or mild non-proliferative retinopathy
Arm Title
Healthy subjects
Arm Type
Other
Arm Description
24 healthy age-and sex- matched control subjects
Intervention Type
Device
Intervention Name(s)
FDOCT
Other Intervention Name(s)
Fourier Domain Color Doppler Optical Coherence Tomography
Intervention Description
Measurement of retinal blood velocities
Intervention Type
Other
Intervention Name(s)
Dynamic Vessel Analyzer
Intervention Description
Measurement of retinal vessel diameters
Primary Outcome Measure Information:
Title
Total retinal blood flow
Description
Measurement of total retinal blood flow using the Dynamic Vessel Analyzer and Optical Coherence Tomography
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Retinal vessel diameter
Description
Measurement of retinal vessel diameter using the Dynamic Vessel Analyzer
Time Frame
1 day
Title
Retinal blood velocities
Description
Measurement of retinal blood flow velocities using Fourier Domain Optical Coherence Tomography
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Garhoefer, MD
Organizational Affiliation
Department of Clinical Pharmacology, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Pharmacology
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
28547132
Citation
Fondi K, Wozniak PA, Howorka K, Bata AM, Aschinger GC, Popa-Cherecheanu A, Witkowska KJ, Hommer A, Schmidl D, Werkmeister RM, Garhofer G, Schmetterer L. Retinal oxygen extraction in individuals with type 1 diabetes with no or mild diabetic retinopathy. Diabetologia. 2017 Aug;60(8):1534-1540. doi: 10.1007/s00125-017-4309-0. Epub 2017 May 25.
Results Reference
derived
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Measurement of Total Retinal Blood Flow in Patients With Diabetes and Healthy Subjects
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