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Evaluation of Blood Flow Regulation With Laser Speckle Flowgraphy

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03391518
Recruitment Status : Active, not recruiting
First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Augenabteilung Allgemeines Krankenhaus Linz

Brief Summary:
The study includes Caucasian patients with diagnosis of normal tension glaucoma and age- and sex-matched healthy individuals. Measurements of optic nerve head blood flow will be performed with laser speckle flowgraphy (LSFG). Also, the intraocular pressure (IOP), systolic and diastolic blood pressure, heart rate (HR), mean arterial pressure (MAP) as well as ocular perfusion pressure (OPP) will be evaluated. After baseline measurements individuals will be asked to ingest 800 ml of water in less than five minutes. Measurements will be repeated after 15, 30 and 45 minutes.

Condition or disease Intervention/treatment Phase
Low Tension Glaucoma Procedure: Water drinking test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of Blood Flow Regulation With Laser Speckle Flowgraphy in Patients With Normal Tension Glaucoma and Healthy Individuals.
Actual Study Start Date : February 5, 2017
Actual Primary Completion Date : December 4, 2017
Estimated Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Water drinking test
    Ingestion of 800 ml water in less than 5 minutes.


Primary Outcome Measures :
  1. Change in ONH blood flow induced by water drinking test [ Time Frame: baseline, after 15, 30 and 45 minutes ]
    ONH blood flow evaluated by laser speckle flowgraphy



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • presence of glaucomatous optic disc changes in biomicroscopy and visual field defects or abnormal circumpapillary retinal nerve fibre layer (RNFL) thinning (evaluated by OCT as defined by the on-board software)
  • IOP ≤ 21mmHg without therapy
  • normal open angle in a gonioscopic examination
  • age > 40 years

Exclusion Criteria:

  • IOP > 21 mmHg in patients' history
  • ametropia > 6 diopters
  • cataract with severity greater than grade 2 of the lens opacities classification system (LOCS) classification
  • presence of corneal opacities
  • uncontrolled hypertension with systolic blood pressure (SBP) > 165mmHg and/or diastolic blood pressure (DBP) > 100mmHg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391518


Locations
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Austria
AKh Linz
Linz, Oberösterreich, Austria, 4021
Sponsors and Collaborators
Augenabteilung Allgemeines Krankenhaus Linz

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Responsible Party: Augenabteilung Allgemeines Krankenhaus Linz
ClinicalTrials.gov Identifier: NCT03391518     History of Changes
Other Study ID Numbers: LSFG_WDT
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases