Evaluation of Blood Flow Regulation With Laser Speckle Flowgraphy

NCT ID: NCT03391518

Last Updated: 2018-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-05

Study Completion Date

2018-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Low Tension Glaucoma

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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Water drinking test

Ingestion of 800 ml water in less than 5 minutes.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Augenabteilung Allgemeines Krankenhaus Linz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AKh Linz

Linz, Upper Austria, Austria

Site Status

Countries

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Austria

Other Identifiers

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LSFG_WDT

Identifier Type: -

Identifier Source: org_study_id

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