H40.1
Conditions
Interventions
Group 1: Classic transorbital electrostimulation is carried out using 2 electrodes placed in the area of ??the temples. The desired line of sight of the patient is straight ahead. Duration per stimula
Sponsors
Universitätsmedizin Göttingen
Eligibility
Sex/Gender
All
Age
40 Years to 84 Years
Inclusion criteria
Inclusion criteria: - Patients with diagnosis of primary open-angle, PEX or pigment dispersion glaucoma (according to the EGS criteria), glaucomatous optic atrophy and significant visual field impairment typical for glaucoma (mean defect >5dB) - Age >/= 40 years - Typical glaucomatous optic disc damage and visual field loss in one eye and either visual field loss or typical glaucomatous optic disc damage or both in the other eye - Familiarity with static perimetry (at least 5 examinations before starting this study) - Intraocular pressure <22 mmHg (topically treated or untreated) - signed informed consent and willingness to participate
Exclusion criteria
Exclusion criteria: - any other type of glaucoma except POWG - Age > 84 years - Visual field defect (mean defect) >/= 22dB or 2dB between screening (day -28) and the first initial examination (day -21) - Vision-related affection of the refracting media (e.g., cataract or corneal scars) that would affect the assessment of study effects - other ophthalmological reasons for visual impairment (e.g. age-related macular degeneration, diabetic retinopathy, optic atrophy of other origins apart from POAG, vascular occlusion) - any surgical procedure within 3 months prior to study entry - Status post glaucoma surgery or eye pressure-reducing laser or cryotherapy within 3 months prior to study entry - Status post intraocular surgery within 6 months prior to study entry - Any glaucoma medication change within 3 months prior to study entry and/or use of more than 2 local (or oral) antihypertensive drugs at baseline - Refractive error: spherical equivalent greater than +/-6dpt, cylinder value greater than 3dpt - Patients with comprehensible visual field impairments caused by ptosis or dermatochalasis. - Women of childbearing age without contraception, pregnancy, breastfeeding mothers - neurological diseases (stroke, seizures, epilepsy, status post brain surgery, pathological nystagmus) - uncontrolled high blood pressure (>160 mmHg) - Claustrophobia - Electronic implants (e.g. pacemakers, brain implants) or metallic artefacts on the head - Mental illnesses (e.g. schizophrenia, addictions, substance dependency) that do not allow the person to assess the nature and scope as well as possible consequences of the clinical study - Inability to understand the nature of the study and provide valid informed consent - Signs that the patient will probably not attend the necessary visits (e.g. lack of willingness to cooperate, lack of compliance) - Participation in other clinical studies within the last 12 weeks before the start of the study - Autoimmune diseases in the acute stage - Acute (intra-)ocular inflammation in the study or companion eye - Therapy with opiates, calcium antagonists or benzodiazepines - Unwillingness for an MRI examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim of this clinical study is to examine the effectiveness of the classic electrical stimulation method by comparing it with sham stimulation. For this purpose, the mean defect (MD) immediately after the treatment (days 9, 16 and 23) is compared with the values ??of the initial examination (days -21, -14 and 0) (analysis of the short-term effect). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Success of individualized electrostimulation: change in MD between initial examination (days -21, -14 and 0) and measurement after treatment (days 9, 16 and 23) compared to sham and classic electrostimulation - Long-term effect: change in MD 24 weeks (day 149 + 3 days) after classic electrostimulation, individualized electrostimulation and sham stimulation in relation to the initial examination - Questionnaire on subjective changes in vision (NEI-VFQ-25): analysis of group differences and changes over time after the last stimulation (day 9) and after 24 weeks compared to the baseline examination (day -14) - Quality of Life Impact Questionnaire (SF-36): Analysis of group differences and changes over time after the last stimulation (Day 9) and after 24 weeks compared to baseline (Day -14) | — |
Countries
Germany
Contacts
Public ContactJohanna Pohlner
Augenklinik der Universitätsklinik Göttingen
Outcome results
None listed