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Status unknownNCT03391518Updated Jan 5, 2018

Evaluation of Blood Flow Regulation With Laser Speckle Flowgraphy

An interventional study of Water drinking test in Low Tension Glaucoma, sponsored by Augenabteilung Allgemeines Krankenhaus Linz. Status unknown at 1 site in Austria. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-05.

Sponsored by Augenabteilung Allgemeines Krankenhaus Linz · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Feb 2017, registered Dec 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
18
Ages
40 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Low Tension Glaucoma

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03

In context

Low Tension Glaucoma

65 studies on the registry are indexed under Low Tension Glaucoma; 10 are open to participants now.

This study's enrollment of 18 is below the median of 42 across 32 interventional studies indexed under Low Tension Glaucoma.

Browse Low Tension Glaucoma studies →

Lead sponsor

Augenabteilung Allgemeines Krankenhaus Linz is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Interventions

  • ProcedureWater drinking test

    Ingestion of 800 ml water in less than 5 minutes.

06

What researchers measure

Primary outcomes

  1. Change in ONH blood flow induced by water drinking test

    ONH blood flow evaluated by laser speckle flowgraphy

    Time frame: baseline, after 15, 30 and 45 minutes

07

Study locations

1 site
  • AKh Linz
    Linz, Oberösterreich 4021, Austria
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2017 to primary completion in Dec 2017, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 30, 2017
First posted
Jan 5, 2018
StartActual
Feb 5, 2017
Primary completionActual
Dec 4, 2017
CompletionEst.
Jan 31, 2018
Last update
Jan 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03391518
Lead sponsor
Augenabteilung Allgemeines Krankenhaus Linz
Responsible party
Sponsor
First posted
Jan 5, 2018
Start date
Feb 5, 2017
Primary completion
Dec 4, 2017
Completion
Jan 31, 2018 (estimated)
Last update
Jan 5, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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