DRKS00029129Recruiting未知
Transorbital electrical stimulation as a vision restoration tool in patients with significant optic atrophy due to primary open-angle glaucoma. Acronym: VIROA (Vision Restoration in Optic Atrophy) - VIRON (Vision Restoration in Optic Neuropathy)
niversitätsmedizin Göttingen0 sites300 target enrollmentStarted: November 10, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 40 Years to 79 Years (—)
- Sex
- All
Inclusion Criteria
- •Patients with diagnosis of primary open-angle 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
- •- any other type of glaucoma except POWG
- •- Age > 80 years
- •- Visual field defect (mean defect) >/= 22dB or <5dB
- •- Visual acuity decimal <0.2
- •- Deviation of the mean defect (MD) of >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
Investigators
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