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Transcorneal Electrical Stimulation Therapy for Retinal Disease

Primary Purpose

Retinitis Pigmentosa, Macula Off, Primary Open Angle Glaucoma

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Transcorneal Electrical Stimulation

DTL-electrode attached without energy

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Active Comparator

Sham Comparator

Arm Label

Retinitis pigmentosa

Macula off

Primary open angle Glaucoma

Hereditary Macular Degeneration

Treated Retina detachment

Retinal Artery Occlusion

Retinal Vein Occlusion

Non-Arteriitic-Anterior-Ischemic Optic-Neuropathy

Hereditary autosomal dominant Optic atrophy

dry Age-related Macular Degeneration

Ischemic Macula edema

Non-stimulated

Arm Description

condition after treatment of retinal detachment

Outcomes

Primary Outcome Measures

enhanced field of vision, enhanced visual acuity, lower threshold for electrical evoked phosphenes

Secondary Outcome Measures

Full Information

NCT ID

NCT00804102

First Posted

December 5, 2008

Last Updated

May 3, 2012

Sponsor

Okuvision GmbH

1. Study Identification

Unique Protocol Identification Number

NCT00804102

Brief Title

Transcorneal Electrical Stimulation Therapy for Retinal Disease

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Okuvision GmbH

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Retinitis pigmentosa

Arm Type

Active Comparator

Arm Title

Macula off

Arm Type

Active Comparator

Arm Description

condition after treatment of retinal detachment

Arm Title

Primary open angle Glaucoma

Arm Type

Active Comparator

Arm Title

Hereditary Macular Degeneration

Arm Type

Active Comparator

Arm Title

Treated Retina detachment

Arm Type

Active Comparator

Arm Title

Retinal Artery Occlusion

Arm Type

Active Comparator

Arm Title

Retinal Vein Occlusion

Arm Type

Active Comparator

Arm Title

Non-Arteriitic-Anterior-Ischemic Optic-Neuropathy

Arm Type

Active Comparator

Arm Title

Hereditary autosomal dominant Optic atrophy

Arm Type

Active Comparator

Arm Title

dry Age-related Macular Degeneration

Arm Type

Active Comparator

Arm Title

Ischemic Macula edema

Arm Type

Active Comparator

Arm Title

Non-stimulated

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

Transcorneal Electrical Stimulation

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

DTL-electrode attached without energy

Intervention Description

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

Primary Outcome Measure Information:

Title

enhanced field of vision, enhanced visual acuity, lower threshold for electrical evoked phosphenes

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Florian Gekeler, MD, Prof

Organizational Affiliation

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

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

21467183

Citation

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.

Results Reference

result

PubMed Identifier

23049087

Citation

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.

Results Reference

derived

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Transcorneal Electrical Stimulation Therapy for Retinal Disease

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