Clinical trial NCT03318510: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma, Primary Open Angle
Lead sponsor: Augenabteilung Allgemeines Krankenhaus Linz
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


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

Primary outcomes:
measure: Mean blur ratio (LSFG)
timeFrame: 4 seconds
Secondary outcomes:
measure: Pulse-waveform parameters (LSFG)
timeFrame: 4 seconds
Other outcomes:
Locations:
city: Linz
country: Austria
facility: AKh Linz
state: Oberösterreich
Study officials:
References: