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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
December 5, 2008
May 3, 2012
January 2008
April 2011   (Final data collection date for primary outcome measure)
enhanced field of vision, enhanced visual acuity, lower threshold for electrical evoked phosphenes [ Time Frame: 3 years ]
enhanced field of vision, lower threshold for electrical evoked phosphenes [ Time Frame: 3 years ]
Complete list of historical versions of study NCT00804102 on ClinicalTrials.gov Archive Site
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Not Provided
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Transcorneal Electrical Stimulation Therapy for Retinal Disease
Transcorneal Electrical Stimulation Therapy for Retinal Disease - A Randomized, Single-blind Pilot Study
Transcorneal stimulation may enable neurons to survive degeneration processes via enhanced secretion of neurotrophic substances and direct stimulation of neurons.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
  • 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
    Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
  • 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.
  • Active Comparator: Retinitis pigmentosa
    Intervention: Device: Transcorneal Electrical Stimulation
  • Active Comparator: Macula off
    condition after treatment of retinal detachment
    Intervention: Device: Transcorneal Electrical Stimulation
  • Active Comparator: Primary open angle Glaucoma
    Intervention: Device: Transcorneal Electrical Stimulation
  • Active Comparator: Hereditary Macular Degeneration
    Intervention: Device: Transcorneal Electrical Stimulation
  • Active Comparator: Treated Retina detachment
    Intervention: Device: Transcorneal Electrical Stimulation
  • Active Comparator: Retinal Artery Occlusion
    Intervention: Device: Transcorneal Electrical Stimulation
  • Active Comparator: Retinal Vein Occlusion
    Intervention: Device: Transcorneal Electrical Stimulation
  • Active Comparator: Non-Arteriitic-Anterior-Ischemic Optic-Neuropathy
    Intervention: Device: Transcorneal Electrical Stimulation
  • Active Comparator: Hereditary autosomal dominant Optic atrophy
    Intervention: Device: Transcorneal Electrical Stimulation
  • Active Comparator: dry Age-related Macular Degeneration
    Intervention: Device: Transcorneal Electrical Stimulation
  • Active Comparator: Ischemic Macula edema
    Intervention: Device: Transcorneal Electrical Stimulation
  • Sham Comparator: Non-stimulated
    Intervention: Device: DTL-electrode attached without energy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
April 2011
April 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00804102
EST-2008
Yes
Not Provided
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Okuvision GmbH
Okuvision GmbH
Not Provided
Principal Investigator: Florian Gekeler, MD, Prof University-Eye-Hospital, Centre for Ophthalmology, D-72076 Tübingen, Germany
Okuvision GmbH
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP