Status:
UNKNOWN
LSFG in Patients With Normal Tension Glaucoma Tension Glaucoma
Lead Sponsor:
Augenabteilung Allgemeines Krankenhaus Linz
Conditions:
Glaucoma, Primary Open Angle
Eligibility:
All Genders
50+ years
Phase:
NA
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03318510
Start Date
January 1 2017
End Date
December 1 2017
Last Update
October 24 2017
Active Locations (1)
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1
AKh Linz
Linz, Upper Austria, Austria, 4021