LSFG in Patients With Normal Tension Glaucoma Tension Glaucoma

Glaucoma, Primary Open Angle Clinical Trial

Official title:

Laser Speckle Flowgraphy in Patients With Normal Tension Glaucoma - a Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03318510
• Other study ID #: AO Form 01-05/1.0
• Status: Active, not recruiting
• Phase: N/A
• First received: October 19, 2017
• Last updated: October 19, 2017
• Start date: January 1, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: October 2017
• Source: Augenabteilung Allgemeines Krankenhaus Linz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 1, 2017
• Est. primary completion date: November 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Glaucoma, Primary Open Angle
• Low Tension Glaucoma

Intervention

Device:
• Laser 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.

Locations

Country	Name	City	State
Austria	AKh Linz	Linz	Oberösterreich

Sponsors (1)

Lead Sponsor	Collaborator
Augenabteilung Allgemeines Krankenhaus Linz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean blur ratio (LSFG)		4 seconds
Secondary	Pulse-waveform parameters (LSFG)		4 seconds