Transcorneal Electrical Stimulation Therapy for Retinal Disease

NCT ID: NCT00804102

Last Updated: 2012-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-04-30

Brief Summary

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

Detailed Description

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Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Retinitis pigmentosa

Group Type ACTIVE_COMPARATOR

Transcorneal Electrical Stimulation

Intervention Type DEVICE

Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.

Macula off

condition after treatment of retinal detachment

Group Type ACTIVE_COMPARATOR

Transcorneal Electrical Stimulation

Intervention Type DEVICE

Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.

Primary open angle Glaucoma

Group Type ACTIVE_COMPARATOR

Transcorneal Electrical Stimulation

Intervention Type DEVICE

Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.

Hereditary Macular Degeneration

Group Type ACTIVE_COMPARATOR

Transcorneal Electrical Stimulation

Intervention Type DEVICE

Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.

Treated Retina detachment

Group Type ACTIVE_COMPARATOR

Transcorneal Electrical Stimulation

Intervention Type DEVICE

Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.

Retinal Artery Occlusion

Group Type ACTIVE_COMPARATOR

Transcorneal Electrical Stimulation

Intervention Type DEVICE

Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.

Retinal Vein Occlusion

Group Type ACTIVE_COMPARATOR

Transcorneal Electrical Stimulation

Intervention Type DEVICE

Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.

Non-Arteriitic-Anterior-Ischemic Optic-Neuropathy

Group Type ACTIVE_COMPARATOR

Transcorneal Electrical Stimulation

Intervention Type DEVICE

Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.

Hereditary autosomal dominant Optic atrophy

Group Type ACTIVE_COMPARATOR

Transcorneal Electrical Stimulation

Intervention Type DEVICE

Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.

dry Age-related Macular Degeneration

Group Type ACTIVE_COMPARATOR

Transcorneal Electrical Stimulation

Intervention Type DEVICE

Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.

Ischemic Macula edema

Group Type ACTIVE_COMPARATOR

Transcorneal Electrical Stimulation

Intervention Type DEVICE

Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.

Non-stimulated

Group Type SHAM_COMPARATOR

DTL-electrode attached without energy

Intervention Type DEVICE

DTL-electrode attached to patient eye receives no energy from neurostimulator. Treatment times remain the same as used for each treatment arm.

Interventions

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Transcorneal Electrical Stimulation

Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Okuvision GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florian Gekeler, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

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

References

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Schatz A, Rock T, Naycheva L, Willmann G, Wilhelm B, Peters T, Bartz-Schmidt KU, Zrenner E, Messias A, Gekeler F. Transcorneal electrical stimulation for patients with retinitis pigmentosa: a prospective, randomized, sham-controlled exploratory study. Invest Ophthalmol Vis Sci. 2011 Jun 23;52(7):4485-96. doi: 10.1167/iovs.10-6932.

Reference Type RESULT
PMID: 21467183 (View on PubMed)

Naycheva L, Schatz A, Rock T, Willmann G, Messias A, Bartz-Schmidt KU, Zrenner E, Gekeler F. Phosphene thresholds elicited by transcorneal electrical stimulation in healthy subjects and patients with retinal diseases. Invest Ophthalmol Vis Sci. 2012 Nov 1;53(12):7440-8. doi: 10.1167/iovs.12-9612.

Reference Type DERIVED
PMID: 23049087 (View on PubMed)

Other Identifiers

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EST-2008

Identifier Type: -

Identifier Source: org_study_id

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