Transcorneal Electrical Stimulation Therapy for Retinal Disease

Study Overview
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Brief Summary
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Transcorneal stimulation may enable neurons to survive degeneration processes via enhanced secretion of neurotrophic substances and direct stimulation of neurons.

Official Title
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Transcorneal Electrical Stimulation Therapy for Retinal Disease - A Randomized, Single-blind Pilot Study

Conditions
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Retinitis Pigmentosa, Macula Off, Primary Open Angle Glaucoma, Hereditary Macular Degeneration, Treated Retina Detachment, Retinal Artery Occlusion, Retinal Vein Occlusion, Non-Arthritic-Anterior-Ischemic Optic-Neuropathy, Hereditary Autosomal Dominant Optic Atrophy, Dry Age Related Macular Degeneration, Ischemic Macula Edema

Intervention / Treatment
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* Device: Transcorneal Electrical Stimulation
* Device: DTL-electrode attached without energy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Retinitis pigmentosa, Macula off, Primary open angle Glaucoma, Hereditary Macular Degeneration, Treated Retina detachment, Retinal Artery Occlusion, Retinal Vein Occlusion, Non-Arthritic-Anterior-Ischemic Optic-Neuropathy, Hereditary autosomal dominant Optic atrophy, dry Age-related Macular Degeneration, Ischemic Macula edema Exclusion Criteria: Severe other disease such as non-proliferative diabetic retinopathy, exudative Age-related Macular Degeneration Age above 99 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Retinitis pigmentosa<br> | Device: Transcorneal Electrical Stimulation<br>* Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.<br>|
| Active Comparator: Macula off<br>condition after treatment of retinal detachment | Device: Transcorneal Electrical Stimulation<br>* Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.<br>|
| Active Comparator: Primary open angle Glaucoma<br> | Device: Transcorneal Electrical Stimulation<br>* Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.<br>|
| Active Comparator: Hereditary Macular Degeneration<br> | Device: Transcorneal Electrical Stimulation<br>* Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.<br>|
| Active Comparator: Treated Retina detachment<br> | Device: Transcorneal Electrical Stimulation<br>* Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.<br>|
| Active Comparator: Retinal Artery Occlusion<br> | Device: Transcorneal Electrical Stimulation<br>* Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.<br>|
| Active Comparator: Retinal Vein Occlusion<br> | Device: Transcorneal Electrical Stimulation<br>* Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.<br>|
| Active Comparator: Non-Arteriitic-Anterior-Ischemic Optic-Neuropathy<br> | Device: Transcorneal Electrical Stimulation<br>* Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.<br>|
| Active Comparator: Hereditary autosomal dominant Optic atrophy<br> | Device: Transcorneal Electrical Stimulation<br>* Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.<br>|
| Active Comparator: dry Age-related Macular Degeneration<br> | Device: Transcorneal Electrical Stimulation<br>* Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.<br>|
| Active Comparator: Ischemic Macula edema<br> | Device: Transcorneal Electrical Stimulation<br>* Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.<br>|
| Sham Comparator: Non-stimulated<br> | Device: DTL-electrode attached without energy<br>* DTL-electrode attached to patient eye receives no energy from neurostimulator. Treatment times remain the same as used for each treatment arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| enhanced field of vision, enhanced visual acuity, lower threshold for electrical evoked phosphenes |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retinitis pigmentosa, Macula off, Primary open angle Glaucoma, Hereditary Macular Degeneration, Treated Retina detachment, Retinal Artery Occlusion, Retinal Vein Occlusion,, Non-Arthritic-Anterior-Ischemic Optic-Neuropathy, Hereditary autosomal dominant Optic atrophy, dry Age-related Macular Degeneration, Ischemic Macula edema