Transcorneal Electrical Stimulation Therapy for Retinal Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Okuvision GmbH
ClinicalTrials.gov Identifier:
NCT00804102
First received: December 5, 2008
Last updated: May 3, 2012
Last verified: May 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Eye Diseases, Hereditary
Macular Degeneration
Ischemia
Retinal Vein Occlusion
Retinitis
Glaucoma
Glaucoma, Open-Angle
Atrophy
Optic Nerve Diseases
Retinitis Pigmentosa
Retinal Diseases
Optic Neuropathy, Ischemic
Retinal Artery Occlusion
Optic Atrophy
Optic Atrophy, Autosomal Dominant
Retinal Detachment
Retinal Degeneration
Eye Diseases
Pathologic Processes
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Ocular Hypertension
Pathological Conditions, Anatomical
Cranial Nerve Diseases
Nervous System Diseases
Retinal Dystrophies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 16, 2014