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LSFG in Patients With Normal Tension Glaucoma Tension Glaucoma

Sponsor
Augenabteilung Allgemeines Krankenhaus Linz (Other)
Overall Status
Unknown status
CT.gov ID
NCT03318510
Collaborator
(none)
40
Enrollment
1
Location
11
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: Laser Speckle Flowgraphy
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Laser Speckle Flowgraphy in Patients With Normal Tension Glaucoma - a Pilot Study
Actual Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Nov 20, 2017
Anticipated Study Completion Date :
Dec 1, 2017

Outcome Measures

Primary Outcome Measures

  1. Mean blur ratio (LSFG) [4 seconds]

Secondary Outcome Measures

  1. Pulse-waveform parameters (LSFG) [4 seconds]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 AKh Linz Linz Oberösterreich Austria 4021

Sponsors and Collaborators

  • Augenabteilung Allgemeines Krankenhaus Linz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Matthias Bolz, Prof., Augenabteilung Allgemeines Krankenhaus Linz
ClinicalTrials.gov Identifier:
NCT03318510
Other Study ID Numbers:
  • AO Form 01-05/1.0
First Posted:
Oct 24, 2017
Last Update Posted:
Oct 24, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Glaucoma
Low Tension Glaucoma
Glaucoma, Open-Angle

Study Results

No Results Posted as of Oct 24, 2017