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Completed

NCT Number: NCT01843114

Measurement of Total Retinal Blood Flow in Patients With Diabetes and Healthy Subjects

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Pharmacology

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FDOCT

Device

Measurement of retinal blood velocities

Other names: Fourier Domain Color Doppler Optical Coherence Tomography

Dynamic Vessel Analyzer

Other

Measurement of retinal vessel diameters

Primary outcomes

  1. Total retinal blood flow

    Time frame: 1 day

    Measurement of total retinal blood flow using the Dynamic Vessel Analyzer and Optical Coherence Tomography

Secondary outcomes

  1. Retinal vessel diameter

    Time frame: 1 day

    Measurement of retinal vessel diameter using the Dynamic Vessel Analyzer

  2. Retinal blood velocities

    Time frame: 1 day

    Measurement of retinal blood flow velocities using Fourier Domain Optical Coherence Tomography

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Apr 30, 2013
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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