Transcorneal Electrical Stimulation Therapy for Retinal Disease - Full Text View

Sponsored by:	Okuvision GmbH
Information provided by:	Okuvision GmbH
ClinicalTrials.gov Identifier:	NCT00804102

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-Arteriitic-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

Genetics Home Reference related topics: early-onset glaucoma Lenz microphthalmia syndrome mitochondrial neurogastrointestinal encephalopathy disease oculofaciocardiodental syndrome Peters plus syndrome X-linked juvenile retinoschisis

MedlinePlus related topics: Edema Glaucoma Macular Degeneration Retinal Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Transcorneal Electrical Stimulation Therapy for Retinal Disease - A Randomized, Single-Blind Pilot Study

Further study details as provided by Okuvision GmbH:

Primary Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	January 2008
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Retinitis pigmentosa: Active Comparator	Device: Transcorneal Electrical Stimulation Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Macula off: Active Comparator 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.
Primary open angle Glaucoma: Active Comparator	Device: Transcorneal Electrical Stimulation Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Hereditary Macular Degeneration: Active Comparator	Device: Transcorneal Electrical Stimulation Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Treated Retina detachment: Active Comparator	Device: Transcorneal Electrical Stimulation Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Retinal Artery Occlusion: Active Comparator	Device: Transcorneal Electrical Stimulation Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Retinal Vein Occlusion: Active Comparator	Device: Transcorneal Electrical Stimulation Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Non-Arteriitic-Anterior-Ischemic Optic-Neuropathy: Active Comparator	Device: Transcorneal Electrical Stimulation Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Hereditary autosomal dominant Optic atrophy: Active Comparator	Device: Transcorneal Electrical Stimulation Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
dry Age-related Macular Degeneration: Active Comparator	Device: Transcorneal Electrical Stimulation Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Ischemic Macula edema: Active Comparator	Device: Transcorneal Electrical Stimulation Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Non-stimulated: Sham Comparator	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-Arteriitic-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, exsudative AMD
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, Assist Prof

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

More Information

No publications provided

Responsible Party:	Okuvision GmbH ( Anuschirawan Hekmat, Ph.D., VP QM & RA, Okuvision GmbH )
Study ID Numbers:	EST-2008
Study First Received:	December 5, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00804102 History of Changes
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-Arteriitic-Anterior-Ischemic Optic-Neuropathy
Hereditary autosomal dominant Optic atrophy
dry Age-related Macular Degeneration
Ischemic Macula edema

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Retinal Artery Occlusion
Retinitis
Optic Atrophy
Edema
Mitochondrial Diseases
Neurodegenerative Diseases
Optic Neuropathy, Ischemic
Pigmentary Retinopathy
Signs and Symptoms
Heredodegenerative Disorders, Nervous System
Optic Nerve Disorder
Glaucoma
Retinal Vein Occlusion
Glaucoma, Open-Angle

Retinitis Pigmentosa
Eye Diseases, Hereditary
Venous Thrombosis
Metabolic Disorder
Retinal Diseases
Arterial Occlusive Diseases
Metabolic Diseases
Eye Diseases
Vascular Diseases
Optic Neuropathy, Anterior Ischemic
Macular Degeneration
Retinal Degeneration
Ischemia
Thrombosis
Cone Rod Dystrophy

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Retinal Artery Occlusion
Retinitis
Optic Atrophy
Edema
Mitochondrial Diseases
Neurodegenerative Diseases
Optic Neuropathy, Ischemic
Signs and Symptoms
Heredodegenerative Disorders, Nervous System
Pathologic Processes
Glaucoma
Retinal Vein Occlusion
Glaucoma, Open-Angle
Retinitis Pigmentosa

Eye Diseases, Hereditary
Venous Thrombosis
Cardiovascular Diseases
Retinal Diseases
Arterial Occlusive Diseases
Metabolic Diseases
Eye Diseases
Nervous System Diseases
Vascular Diseases
Macular Degeneration
Retinal Degeneration
Ischemia
Thrombosis
Embolism and Thrombosis
Retinal Detachment

ClinicalTrials.gov processed this record on May 07, 2009