Measurement of Total Retinal Blood Flow in Patients With Diabetes and Healthy Subjects
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2013
CompletedFirst Posted
Study publicly available on registry
April 30, 2013
CompletedStudy Start
First participant enrolled
January 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 26, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMarch 21, 2017
March 1, 2017
1.6 years
April 26, 2013
March 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total retinal blood flow
Measurement of total retinal blood flow using the Dynamic Vessel Analyzer and Optical Coherence Tomography
1 day
Secondary Outcomes (2)
Retinal vessel diameter
1 day
Retinal blood velocities
1 day
Study Arms (2)
Patients with Type I Diabetes
OTHER24 patients with type I diabetes with no or mild non-proliferative retinopathy
Healthy subjects
OTHER24 healthy age-and sex- matched control subjects
Interventions
Measurement of retinal blood velocities
Measurement of retinal vessel diameters
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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)
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Clinical Pharmacology
Vienna, Vienna, 1090, Austria
Related Publications (1)
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.
PMID: 28547132DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerhard Garhoefer, MD
Department of Clinical Pharmacology, Medical University of Vienna
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof. PD Dr.
Study Record Dates
First Submitted
April 26, 2013
First Posted
April 30, 2013
Study Start
January 12, 2015
Primary Completion
August 26, 2016
Study Completion
March 1, 2017
Last Updated
March 21, 2017
Record last verified: 2017-03