NCT00804102

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

May 4, 2012

Status Verified

May 1, 2012

Enrollment Period

3.2 years

First QC Date

December 5, 2008

Last Update Submit

May 3, 2012

Conditions

Retinitis PigmentosaMacula OffPrimary Open Angle GlaucomaHereditary Macular DegenerationTreated Retina DetachmentRetinal Artery OcclusionRetinal Vein OcclusionNon-Arthritic-Anterior-Ischemic Optic-NeuropathyHereditary Autosomal Dominant Optic AtrophyDry Age Related Macular DegenerationIschemic Macula Edema

Keywords

Retinitis pigmentosaMacula offPrimary open angle GlaucomaHereditary Macular DegenerationTreated Retina detachmentRetinal Artery OcclusionRetinal Vein Occlusion,Non-Arthritic-Anterior-Ischemic Optic-NeuropathyHereditary autosomal dominant Optic atrophydry Age-related Macular DegenerationIschemic Macula edema

Outcome Measures

Primary Outcomes (1)

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

    3 years

Study Arms (12)

Retinitis pigmentosa

ACTIVE COMPARATOR
Device: Transcorneal Electrical Stimulation

Macula off

ACTIVE COMPARATOR

condition after treatment of retinal detachment

Device: Transcorneal Electrical Stimulation

Primary open angle Glaucoma

ACTIVE COMPARATOR
Device: Transcorneal Electrical Stimulation

Hereditary Macular Degeneration

ACTIVE COMPARATOR
Device: Transcorneal Electrical Stimulation

Treated Retina detachment

ACTIVE COMPARATOR
Device: Transcorneal Electrical Stimulation

Retinal Artery Occlusion

ACTIVE COMPARATOR
Device: Transcorneal Electrical Stimulation

Retinal Vein Occlusion

ACTIVE COMPARATOR
Device: Transcorneal Electrical Stimulation

Non-Arteriitic-Anterior-Ischemic Optic-Neuropathy

ACTIVE COMPARATOR
Device: Transcorneal Electrical Stimulation

Hereditary autosomal dominant Optic atrophy

ACTIVE COMPARATOR
Device: Transcorneal Electrical Stimulation

dry Age-related Macular Degeneration

ACTIVE COMPARATOR
Device: Transcorneal Electrical Stimulation

Ischemic Macula edema

ACTIVE COMPARATOR
Device: Transcorneal Electrical Stimulation

Non-stimulated

SHAM COMPARATOR
Device: DTL-electrode attached without energy

Interventions

Transcorneal Electrical StimulationDEVICE

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

Hereditary Macular DegenerationHereditary autosomal dominant Optic atrophyIschemic Macula edemaMacula offNon-Arteriitic-Anterior-Ischemic Optic-NeuropathyPrimary open angle GlaucomaRetinal Artery OcclusionRetinal Vein OcclusionRetinitis pigmentosaTreated Retina detachmentdry Age-related Macular Degeneration
DTL-electrode attached without energyDEVICE

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

Non-stimulated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe other disease such as non-proliferative diabetic retinopathy, exudative Age-related Macular Degeneration
  • Age above 99 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 21467183RESULT

  • 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.

    PMID: 23049087DERIVED

MeSH Terms

Conditions

Retinitis PigmentosaGlaucoma, Open-AngleRetinal Artery OcclusionRetinal Vein OcclusionOptic Atrophy, Autosomal Dominant

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGlaucomaOcular HypertensionArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisOptic Atrophies, HereditaryOptic AtrophyOptic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesMitochondrial DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Florian Gekeler, MD, Prof

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2008

First Posted

December 8, 2008

Study Start

January 1, 2008

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

May 4, 2012

Record last verified: 2012-05