Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation: a Home Stimulation Study
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Glaucoma
- Sponsor
- University of Magdeburg
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Visual field size
- Last Updated
- 6 years ago
Overview
Brief Summary
The aim of the present study is to investigate the possibilities of visual field enhancement with electrical stimulation (ES) as a home stimulation method, in a total of 50 patients with optical neuropathy, who have already been treated with ES in the past.
Furthermore, factors responsible for response variability and treatment effectiveness are also explored: (i) the role of mental stress (or stress resilience), (ii) the status of biomarkers, such as the systemic stress hormone levels and blood supply to the eye and brain (specifically vascular dysregulation) and (iii) the influence of personality, anxiety, depression and lifestyle. The study serves to further validate this ES procedure for the treatment of visual impairment. Specifically, better efficacy, better compliance, lowest response variability are expected after long-term home use.
Investigators
Bernhard A. Sabel
Head of Institute, Professor
University of Magdeburg
Eligibility Criteria
Inclusion Criteria
- •Patients with glaucoma, disease duration at least 6 months
- •stable visual field defect across baseline measurement (subjects with spontaneous fluctuations and recovery of vision excluded)
- •presence of residual vision and detectable gradual transition between the intact and the absolutely blind part of the visual field according to evaluation of the clinician
- •best corrected visual acuity at least 0.4 (20/50 Snellen) or better
Exclusion Criteria
- •autoimmune diseases in the acute stage
- •neurological and mental diseases
- •diabetic retinopathy
- •addictions
- •hypertension (maximum 160/100 mmHg)
- •retinitis pigmentosa-
- •pathological nystagmus
- •non-distant tumors or recurrent tumors
- •photosensitivity
- •pregnancy
Outcomes
Primary Outcomes
Visual field size
Time Frame: 3 months
Static perimetry and high resolution perimetry will be used to measure the visual field sizes
Secondary Outcomes
- EEG connectivities in the visual system(3 months)
- Level of vascular regulation/dysregulation in the eye(3 months)