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LSFG in Patients With Normal Tension Glaucoma Tension Glaucoma

Primary Purpose

Glaucoma, Primary Open Angle

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Laser Speckle Flowgraphy
Sponsored by
Augenabteilung Allgemeines Krankenhaus Linz
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma, Primary Open Angle

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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, autoimmune, 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:

  • 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 clinically relevant illness in the 3 weeks before the first study day
  • Ocular infection or clinically significant inflammation
  • Pregnancy, planned pregnancy or lactating

Sites / Locations

  • AKh Linz

Outcomes

Primary Outcome Measures

Mean blur ratio (LSFG)

Secondary Outcome Measures

Pulse-waveform parameters (LSFG)

Full Information

First Posted
October 19, 2017
Last Updated
October 19, 2017
Sponsor
Augenabteilung Allgemeines Krankenhaus Linz
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1. Study Identification

Unique Protocol Identification Number
NCT03318510
Brief Title
LSFG in Patients With Normal Tension Glaucoma Tension Glaucoma
Official Title
Laser Speckle Flowgraphy in Patients With Normal Tension Glaucoma - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
November 20, 2017 (Anticipated)
Study Completion Date
December 1, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
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
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Primary Open Angle

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Laser Speckle Flowgraphy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean blur ratio (LSFG)
Time Frame
4 seconds
Secondary Outcome Measure Information:
Title
Pulse-waveform parameters (LSFG)
Time Frame
4 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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, autoimmune, 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: 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 clinically relevant illness in the 3 weeks before the first study day Ocular infection or clinically significant inflammation Pregnancy, planned pregnancy or lactating
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

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LSFG in Patients With Normal Tension Glaucoma Tension Glaucoma

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