ClinicalTrials.gg
Status unknownNCT03318510Updated Oct 24, 2017

LSFG in Patients With Normal Tension Glaucoma Tension Glaucoma

An interventional study of Laser Speckle Flowgraphy in Glaucoma, Primary Open Angle, sponsored by Augenabteilung Allgemeines Krankenhaus Linz. Status unknown at 1 site in Austria. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-24.

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

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this record recently (last verified Oct 2017), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jan 2017, registered Oct 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 30 studies in Glaucoma, Open-Angle with a site in Austria — 6 open to participants now, 7 under way, none of them phase 3. Glaucoma, Open-Angle · Austria.

Enrollment
16th of 22
40 · median 91
Started
2017
with 3 others
No phase
10 of 30
4 open now
Registered
21st of 30
by date
Lead sponsor
1 of 30
Augenabteilung Allgemeines Krankenhaus Linz

Among the 30 studies in Glaucoma, Open-Angle with a site in Austria, this one is the 16th largest by enrollment of the 22 interventional ones, is one of 4 that started in 2017, is one of 10 with no phase, and was the 21st registered.

By phase

30 studies; the count open now beside each. This study's row is marked.

No phasethis study10 · 4 open
Observational8 · 2 open
Phase 46 · 0 open
Phase 32 · 0 open
Phase 11 · 0 open
Phase 1/21 · 0 open
Phase 21 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 1999; this study’s year is marked. 4 started in 2017.

Size and results

Median enrollment 91 across the 22 interventional studies, 310 across the 8 observational. Of the 19 that completed or were terminated, 5 (26%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 30 studies in Glaucoma, Open-Angle with a site in Austria, or all of them as a file.
02

Study summary

Glaucoma is the second leading cause of blindness worldwide. Literature shows increasing evidence that dysfunction of ocular microcirculation in the optic nerve influences the progression of glaucoma. Laser speckle flowgraphy (LSFG) represents a non-invasive method to quantify ocular perfusion also at the ONH. LSFG enables noninvasive quantification of microcirculation of the optic disc in Japanese glaucoma patients

03

Conditions studied

  • Glaucoma, Primary Open Angle

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04

Who can participate

Ages eligible
50 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

  • Caucasian men and women aged over 50 years
  • Subject is generally healthy with no current significant or a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, , hematological or renal disorder, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination. A significant disorder is defined as a disease or medical condition associated with impaired health status, requiring regular or current medical treatment and/or follow up. For the purposes of this study, an investigator may classify a medical condition as a nonsignificant disorder despite the fact that the subject receives treatment. Subjects having controlled Stage 1 hypertension (blood pressure of 140-159 mmHg systolic and/or 90-99 mmHg diastolic) are eligible for participation in this study
  • Normal open angle in a gonioscopic examination
  • Presence of glaucomatous optic disc changes in biomicroscopy and
  • Visual field defects in at least two visual field examinations (Reliability criteria: fixation errors \< 20%, false positives \< 15%, and false negatives \< 33%) Or
  • Abnormal circumpapillary retinal nerve fiber layer thinning (RNFL evaluated by OCT)

Exclusion criteria

Exclusion Criteria:

  • History of ocular or systemic disease causing optic nerve damage
  • History of IOP greater than 21 mm Hg (corrected by CCT)
  • Participation in a clinical trial in the 3 weeks preceding the study
  • Ocular surgery (including intravitreal injection) during the 3 months preceding the study
  • Ametropia > 6 Dpt
  • Smoking
  • pre- or perimenopausal women
  • Relevant ophthalmic diseases/conditions that could interfere with LSFG measurements (e.g. optic nerve head drusen, tilted disc, etc.)
  • Opacities of the cornea (e.g. corneal scars, corneal oedema), the lens (e.g. LOCS-II grading > 2, posterior capsule opacification) or the vitreous (e.g. vitreous haemorrhage, asteroid hyalosis)
  • Patients who are not able to cooperate or with insufficient ability to fixate (tremor, nystagmus)
  • Blood donation in the 3 weeks preceding the study
  • Symptoms of a illness in the 3 weeks before the first study day
  • Ocular infection or clinically significant inflammation
  • Pregnancy, planned pregnancy or lactating
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Interventions

  • DeviceLaser Speckle Flowgraphy

    A commercially available LSFG system (LSFG-NAVI; Softcare Co., Ltd., Fukuoka, Japan) will be used in the present study. The LSFG device consists of a fundus camera equipped with a diode laser with a wavelength if 830 nm and charge-coupled device.

06

What researchers measure

Primary outcomes

  1. Mean blur ratio (LSFG)

    Time frame: 4 seconds

Secondary outcomes

  1. Pulse-waveform parameters (LSFG)

    Time frame: 4 seconds

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 reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2017 (actual). Primary completion is estimated for Nov 2017, 10 months after the start.

Of 100 non-industry interventional studies with no phase under Glaucoma, Open-Angle, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 57. This study's planned 10 months is below that.

Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 19 and three quarters within 61.

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

Registered
Oct 19, 2017
First posted
Oct 24, 2017
StartActual
Jan 1, 2017
Primary completionEst.
Nov 20, 2017
CompletionEst.
Dec 1, 2017
Last update
Oct 24, 2017
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 Oct 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03318510
Lead sponsor
Augenabteilung Allgemeines Krankenhaus Linz
Responsible party
Matthias Bolz (Prof., Augenabteilung Allgemeines Krankenhaus Linz) — Principal investigator
First posted
Oct 24, 2017
Start date
Jan 1, 2017
Primary completion
Nov 20, 2017 (estimated)
Completion
Dec 1, 2017 (estimated)
Last update
Oct 24, 2017

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 Oct 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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