Isometric Exercise in NTG

This is an interventional diagnostic trial for Mean Blur Ratio focused on measuring Normal tension glaucoma Read More

1. 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)

2. 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