Transcorneal Electrical Stimulation Therapy for Retinal Disease

Not Applicable

Completed

• Conditions: 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
• Interventions: Device: Transcorneal Electrical Stimulation; Device: DTL-electrode attached without energy

• Registration Number: NCT00804102
• Lead Sponsor: Okuvision GmbH

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-12-05
• Study First Submitted QC: 2008-12-05
• Study First Posted: 2008-12-08
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-03
• Last Update Posted: 2012-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Retinal Artery Occlusion	Transcorneal Electrical Stimulation	-
Retinal Vein Occlusion	Transcorneal Electrical Stimulation	-
Retinitis pigmentosa	Transcorneal Electrical Stimulation	-
Macula off	Transcorneal Electrical Stimulation	condition after treatment of retinal detachment
Primary open angle Glaucoma	Transcorneal Electrical Stimulation	-
Hereditary Macular Degeneration	Transcorneal Electrical Stimulation	-
Treated Retina detachment	Transcorneal Electrical Stimulation	-
Non-Arteriitic-Anterior-Ischemic Optic-Neuropathy	Transcorneal Electrical Stimulation	-
Hereditary autosomal dominant Optic atrophy	Transcorneal Electrical Stimulation	-
dry Age-related Macular Degeneration	Transcorneal Electrical Stimulation	-
Ischemic Macula edema	Transcorneal Electrical Stimulation	-
Non-stimulated	DTL-electrode attached without energy	-

Primary Outcome Measures

Name	Time	Method
enhanced field of vision, enhanced visual acuity, lower threshold for electrical evoked phosphenes	3 years