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CompletedNCT00804102Updated May 4, 2012

Transcorneal Electrical Stimulation Therapy for Retinal Disease

An interventional study of Transcorneal Electrical Stimulation and DTL-electrode attached without energy in Retinitis Pigmentosa, Macula Off and Primary Open Angle Glaucoma, sponsored by Okuvision GmbH. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-04.

Sponsored by Okuvision GmbH · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • 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
03

In context

Retinitis Pigmentosa

278 studies on the registry are indexed under Retinitis Pigmentosa; 72 are open to participants now.

This study's enrollment of 80 is above the median of 27 across 179 interventional studies indexed under Retinitis Pigmentosa.

Browse Retinitis Pigmentosa studies →

Lead sponsor

Okuvision GmbH is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Severe other disease such as non-proliferative diabetic retinopathy, exudative Age-related Macular Degeneration
  • Age above 99 years
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    Retinitis pigmentosa

    Device: Transcorneal Electrical Stimulation

  • Active comparator
    Macula off

    condition after treatment of retinal detachment

    Device: Transcorneal Electrical Stimulation

  • Active comparator
    Primary open angle Glaucoma

    Device: Transcorneal Electrical Stimulation

  • Active comparator
    Hereditary Macular Degeneration

    Device: Transcorneal Electrical Stimulation

  • Active comparator
    Treated Retina detachment

    Device: Transcorneal Electrical Stimulation

  • Active comparator
    Retinal Artery Occlusion

    Device: Transcorneal Electrical Stimulation

  • Active comparator
    Retinal Vein Occlusion

    Device: Transcorneal Electrical Stimulation

  • Active comparator
    Non-Arteriitic-Anterior-Ischemic Optic-Neuropathy

    Device: Transcorneal Electrical Stimulation

  • Active comparator
    Hereditary autosomal dominant Optic atrophy

    Device: Transcorneal Electrical Stimulation

  • Active comparator
    dry Age-related Macular Degeneration

    Device: Transcorneal Electrical Stimulation

  • Active comparator
    Ischemic Macula edema

    Device: Transcorneal Electrical Stimulation

  • Sham comparator
    Non-stimulated

    Device: DTL-electrode attached without energy

Interventions

  • DeviceTranscorneal Electrical Stimulation

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

  • DeviceDTL-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.

06

What researchers measure

Primary outcomes

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

    Time frame: 3 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 21467183 ↗
  • 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. PubMed 23049087 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00804102
Lead sponsor
Okuvision GmbH
Responsible party
Sponsor
First posted
Dec 8, 2008
Start date
Jan 2008
Primary completion
Apr 2011
Completion
Apr 2011
Last update
May 4, 2012

Study contacts

Florian Gekeler, MD, Prof
principal investigator · University-Eye-Hospital, Centre for Ophthalmology, D-72076 Tübingen, Germany

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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