Back to resultsEvaluation of Blood Flow Regulation With Laser Speckle Flowgraphy
Primary Purpose
Low Tension Glaucoma
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Water drinking test
Sponsored by
About this trial
This is an interventional basic science trial for Low Tension Glaucoma
Eligibility 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
Sites / Locations
- AKh Linz
Outcomes
Primary Outcome Measures
Change in ONH blood flow induced by water drinking test
ONH blood flow evaluated by laser speckle flowgraphy
Secondary Outcome Measures
Full Information
NCT ID
NCT03391518
First Posted
December 30, 2017
Last Updated
December 30, 2017
Sponsor
Augenabteilung Allgemeines Krankenhaus Linz
1. Study Identification
Unique Protocol Identification Number
NCT03391518
Brief Title
Evaluation of Blood Flow Regulation With Laser Speckle Flowgraphy
Official Title
Evaluation of Blood Flow Regulation With Laser Speckle Flowgraphy in Patients With Normal Tension Glaucoma and Healthy Individuals.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 5, 2017 (Actual)
Primary Completion Date
December 4, 2017 (Actual)
Study Completion Date
January 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Augenabteilung Allgemeines Krankenhaus Linz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Tension Glaucoma
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Water drinking test
Intervention Description
Ingestion of 800 ml water in less than 5 minutes.
Primary Outcome Measure Information:
Title
Change in ONH blood flow induced by water drinking test
Description
ONH blood flow evaluated by laser speckle flowgraphy
Time Frame
baseline, after 15, 30 and 45 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
AKh Linz
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4021
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Blood Flow Regulation With Laser Speckle Flowgraphy
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