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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 5, 2008

Last Updated Date

May 3, 2012

Start Date ^ICMJE

January 2008

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00804102 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Transcorneal Electrical Stimulation Therapy for Retinal Disease

Official Title ^ICMJE

Transcorneal Electrical Stimulation Therapy for Retinal Disease - A Randomized, Single-blind Pilot Study

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

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.

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2011

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00804102

Other Study ID Numbers ^ICMJE

EST-2008

Has Data Monitoring Committee

Yes

Responsible Party

Okuvision GmbH

Study Sponsor ^ICMJE

Okuvision GmbH

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Florian Gekeler, MD, Prof

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

Information Provided By

Okuvision GmbH

Verification Date

May 2012

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

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