Evaluation of Blood Flow Regulation With Laser Speckle Flowgraphy

Evaluation of Blood Flow Regulation With Laser Speckle Flowgraphy in Patients With Normal Tension Glaucoma and Healthy Individuals.

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.

Study Overview

• Status: Unknown
• Conditions: Low Tension Glaucoma
• Intervention / Treatment: Procedure: Water drinking test

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Oberösterreich
    • Linz, Oberösterreich, Austria, 4021
      • AKH Linz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ONH blood flow induced by water drinking test	ONH blood flow evaluated by laser speckle flowgraphy	baseline, after 15, 30 and 45 minutes

Collaborators and Investigators

• Sponsor: Augenabteilung Allgemeines Krankenhaus Linz

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2017
• Primary Completion (Actual): December 4, 2017
• Study Completion (Anticipated): January 31, 2018

Study Registration Dates

• First Submitted: December 30, 2017
• First Submitted That Met QC Criteria: December 30, 2017
• First Posted (Actual): January 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 5, 2018
• Last Update Submitted That Met QC Criteria: December 30, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Optic Nerve Diseases; Glaucoma; Low Tension Glaucoma
• Other Study ID Numbers: LSFG_WDT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No