Isometric Exercise in NTG

Augenabteilung Allgemeines Krankenhaus Linz

Status

Completed

Conditions

Mean Blur Ratio

Treatments

Diagnostic Test: Isometric exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT03921372

IsometricProtocol2

Details and patient eligibility

About

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. It has been shown that flicker light-induced vasodilatation of retinal veins is diminished in patients with glaucoma. Also previous studies indicate that the blood flow autoregulation is impaired in patients with glaucoma. Therefor the ocular perfusion pressure can not be maintained stable during changes of the systemic arterial blood pressure. 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.

Study Objectives:

To assess the changes in LSFG parameters in patients with normal tension glaucoma, compared to healthy subjects during flicker light stimulation and isometric exercises.

Enrollment

24 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Study population: patients with normal tension glaucoma
- 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)
Control group
- Men and women aged over 18 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
- Baseline IOP in both eyes below 21 mm Hg
- Normal findings in slitlamp and funduscopic examination

Exclusion Criteria:

a) Study population: patients with normal tension glaucoma
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

b) Control group
Abnormal RNFL
Visual field defects
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
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