ClinicalTrials.gov
ClinicalTrials.gov Menu

Non-invasive Measurement of Retinal Blood Flow Based on Vessel Analysis and Fourier Domain Optical Coherence Tomography in Patients With Hypertensive Retinopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01753648
Recruitment Status : Recruiting
First Posted : December 20, 2012
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

December 7, 2012
December 20, 2012
December 29, 2017
January 2015
September 2018   (Final data collection date for primary outcome measure)
Total retinal blood flow [ Time Frame: 1 day ]
Same as current
Complete list of historical versions of study NCT01753648 on ClinicalTrials.gov Archive Site
  • Retinal vessel diameter [ Time Frame: 1 day ]
  • Retinal blood velocities [ Time Frame: 1 day ]
  • Ocular perfusion pressure [ Time Frame: 1 day ]
  • Retinal (arterial and venous) oxygen saturation [ Time Frame: 1 day ]
Same as current
Not Provided
Not Provided
 
Non-invasive Measurement of Retinal Blood Flow Based on Vessel Analysis and Fourier Domain Optical Coherence Tomography in Patients With Hypertensive Retinopathy
Non-invasive Measurement of Retinal Blood Flow Based on Vessel Analysis and Fourier Domain Optical Coherence Tomography in Patients With Hypertensive Retinopathy

Recently, a new and sophisticated method for assessment of retinal blood flow and retinal blood flow velocity profiles has become available. This technique is based on the combination of measurement of retinal vessel calibers with bidirectional Fourier domain optical coherence tomography (FDOCT). The valid measurement of retinal blood flow is of significant importance, because it is known that major ophthalmic diseases, such as hypertensive retinopathy, are associated with alterations in blood flow.

Hypertensive retinopathy is the most common manifestation of arterial hypertension in the eye. Elevated systemic blood pressure leads to generalized arteriolar narrowing caused by vasospasms and increased vascular tone. Further in the disease process, focal arteriolar narrowing, retinal haemorrhages, hard exudates and cotton wool spots can occur. Previous studies have shown that blood flow in the extraocular vessels and in the choroid is compromised in patients with arterial hypertension. However, data on the impact of arterial hypertension on retinal blood flow and retinal blood flow velocities are lacking.

The present study sets out to compare total retinal blood flow and retinal velocity profiles in patients with hypertensive retinopathy and healthy age- and sex-matched controls. Ocular perfusion pressure will be calculated based on measurements of blood pressure and intraocular pressure to allow for calculation of vascular resistance. In addition, velocity profiles at arterio-venous crossings will be measured. It is hypothesized that these velocity profiles are considerably modified in patients with stage 2 and 3 hypertensive retinopathy compared to healthy controls because of pronounced arterio-venous compression.

Not Provided
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Hypertensive Retinopathy
  • Device: Dynamic Vessel Analyzer
    Retinal vessel diameter, total retinal blood flow (together with FD-OCT), retinal oxygen saturation
  • Other: FDOCT
    total retinal blood flow (together with DVA), retinal blood velocities
    Other Name: Fourier Domain Color Doppler Optical Coherence Tomography
  • Other: Ocular perfusion pressure
    Measurement of intraocular pressure and mean arterial blood pressure for determination of ocular perfusion pressure
  • Experimental: hypertensive retinopathy
    30 patients with hypertensive retinopathy stage 2 or 3
    Interventions:
    • Device: Dynamic Vessel Analyzer
    • Other: FDOCT
    • Other: Ocular perfusion pressure
  • Experimental: healthy controls
    30 healthy age- and sex-matched controls
    Interventions:
    • Device: Dynamic Vessel Analyzer
    • Other: FDOCT
    • Other: Ocular perfusion pressure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Same as current
October 2018
September 2018   (Final data collection date for primary outcome measure)

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
  • Systolic Blood Pressure ≤ 120 mmHg and Diastolic Blood Pressure ≤ 80 mmHg
  • Normal ophthalmic findings, ametropia < 6 Dpt.

Inclusion criteria for patients with hypertensive retinopathy

  • Men and women aged over 18 years
  • Hypertensive retinopathy stage 2 or 3
  • Normal ophthalmic findings except hypertensive retinopathy stage 2 and 3, 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
  • Presence or history of arterial hypertension
  • Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptive)
  • Blood donation during the previous three weeks
  • Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
  • Ametropia >= 6 Dpt
  • Pregnancy, planned pregnancy or lactating

Any of the following will exclude a patient with hypertensive retinopathy 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 as judged by the clinical investigator
  • Blood donation during the previous three weeks
  • Hypertensive retinopathy stage 4
  • Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
  • Ametropia >= 6 Dpt
  • Pregnancy, planned pregnancy or lactating
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact: Gerhard Garhoefer, MD +43140400 ext 2981 gerhard.garhoefer@meduniwien.ac.at
Austria
 
 
NCT01753648
OPHT-220612
Yes
Not Provided
Not Provided
Gerhard Garhofer, Medical University of Vienna
Medical University of Vienna
Not Provided
Not Provided
Medical University of Vienna
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP