Transcorneal Electrical Stimulation Therapy for Retinal Disease - Full Text View

Purpose

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

Condition	Intervention
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	Device: Transcorneal Electrical Stimulation Device: DTL-electrode attached without energy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Transcorneal Electrical Stimulation Therapy for Retinal Disease - A Randomized, Single-blind Pilot Study

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration ataxia neuropathy spectrum childhood myocerebrohepatopathy spectrum deoxyguanosine kinase deficiency early-onset glaucoma Lenz microphthalmia syndrome mitochondrial neurogastrointestinal encephalopathy disease myoclonic epilepsy myopathy sensory ataxia oculofaciocardiodental syndrome optic atrophy type 1 Peters plus syndrome retinitis pigmentosa X-linked juvenile retinoschisis

MedlinePlus related topics: Edema Glaucoma Macular Degeneration Retinal Disorders

U.S. FDA Resources

Further study details as provided by Okuvision GmbH:

Primary Outcome Measures:

enhanced field of vision, enhanced visual acuity, lower threshold for electrical evoked phosphenes [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment:	80
Study Start Date:	January 2008
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804102

Sponsors and Collaborators

Okuvision GmbH

Investigators

Principal Investigator:

Florian Gekeler, MD, Prof

University-Eye-Hospital, Centre for Ophthalmology, D-72076 Tübingen, Germany

More Information

Publications:

Schatz A, Röck T, Naycheva L, Willmann G, Wilhelm B, Peters T, Bartz-Schmidt KU, Zrenner E, Messias A, Gekeler F. Transcorneal Electrical Stimulation for Patients with Retinitis Pigmentosa -- a Prospective, Randomized, Sham-Controlled Exploratory Study. Invest Ophthalmol Vis Sci. 2011 Apr 5; [Epub ahead of print]

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Naycheva L, Schatz A, Röck T, Willmann G, Messias A, Bartz-Schmidt KU, Zrenner E, Gekeler F. Phosphene thresholds elicited by transcorneal electrical stimulation in healthy subjects and patients with retinal diseases. Invest Ophthalmol Vis Sci. 2012 Nov 1;53(12):7440-8. doi: 10.1167/iovs.12-9612.

Responsible Party:	Okuvision GmbH
ClinicalTrials.gov Identifier:	NCT00804102 History of Changes
Other Study ID Numbers:	EST-2008
Study First Received:	December 5, 2008
Last Updated:	May 3, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Okuvision GmbH:

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

Additional relevant MeSH terms:

Edema
Glaucoma
Glaucoma, Open-Angle
Ischemia
Macular Degeneration
Optic Atrophy
Optic Nerve Diseases
Retinal Artery Occlusion
Retinal Detachment
Retinal Diseases
Retinal Vein Occlusion
Retinitis
Retinitis Pigmentosa
Optic Neuropathy, Ischemic
Arterial Occlusive Diseases

Atrophy
Optic Atrophy, Autosomal Dominant
Signs and Symptoms
Ocular Hypertension
Eye Diseases
Pathologic Processes
Retinal Degeneration
Cranial Nerve Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Eye Diseases, Hereditary

ClinicalTrials.gov processed this record on May 22, 2013