Transcorneal Electrical Stimulation Therapy for Retinal Disease

Retinitis Pigmentosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804102
• Other study ID #: EST-2008
• Status: Completed
• Phase: N/A
• First received: December 5, 2008
• Last updated: May 3, 2012
• Start date: January 2008
• Est. completion date: April 2011

Study information

• Verified date: May 2012
• Source: Okuvision GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Dry Age Related Macular Degeneration
• Glaucoma
• Glaucoma, Open-Angle
• Hereditary Autosomal Dominant Optic Atrophy
• Hereditary Macular Degeneration
• Ischemia
• Ischemic Macula Edema
• Macula Off
• Macular Degeneration
• Non-Arthritic-Anterior-Ischemic Optic-Neuropathy
• Optic Atrophy
• Optic Atrophy, Autosomal Dominant
• Optic Nerve Diseases
• Optic Neuropathy, Ischemic
• Primary Open Angle Glaucoma
• Retinal Artery Occlusion
• Retinal Detachment
• Retinal Diseases
• Retinal Vein Occlusion
• Retinitis
• Retinitis Pigmentosa
• Treated Retina Detachment

Intervention

Device:
• Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Okuvision GmbH

References & Publications (1)

Schatz A, Röck 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. Inv — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	enhanced field of vision, enhanced visual acuity, lower threshold for electrical evoked phosphenes		3 years