Transcorneal Electrical Stimulation Therapy for Retinal Disease

Sponsor

Okuvision GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT00804102

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

enhanced field of vision, enhanced visual acuity, lower threshold for electrical evoked phosphenes [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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