Overview

This trial is active, not recruiting.

Conditions non-arteritic anterior ischemic optic neuropathy (naion), trauma, multiple sclerosis (ms)
Treatment transcorneal electrical stimulation
Phase phase 1
Sponsor Wills Eye
Collaborator United States Department of Defense
Start date July 2013
End date December 2016
Trial size 120 participants
Trial identifier NCT02019927, 12-232

Summary

Transcorneal Electrical Stimulation (TES) using the "OkuStim®" device delivers electrical impulses to damaged and/or diseased photoreceptor cells. This electric stimulation of the retina may help to preserve visual acuity and/or the visual field.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).
transcorneal electrical stimulation TES
The clinical trial will investigate whether Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany, is a potentially effective therapy for the restoration and rehabilitation of vision loss as measured by improvements in visual acuity in the following three patient populations: patients with ocular trauma, patients with optic neuritis associated with multiple sclerosis and patients with Non-arteritic Anterior Ischemic Optic Neuropathy.
(Active Comparator)
Treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes).
transcorneal electrical stimulation TES
The clinical trial will investigate whether Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany, is a potentially effective therapy for the restoration and rehabilitation of vision loss as measured by improvements in visual acuity in the following three patient populations: patients with ocular trauma, patients with optic neuritis associated with multiple sclerosis and patients with Non-arteritic Anterior Ischemic Optic Neuropathy.
(Active Comparator)
Treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma).
transcorneal electrical stimulation TES
The clinical trial will investigate whether Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany, is a potentially effective therapy for the restoration and rehabilitation of vision loss as measured by improvements in visual acuity in the following three patient populations: patients with ocular trauma, patients with optic neuritis associated with multiple sclerosis and patients with Non-arteritic Anterior Ischemic Optic Neuropathy.

Primary Outcomes

Measure
Visual acuity
time frame: 9-month period

Secondary Outcomes

Measure
Diagnostic testing
time frame: 9-month period

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - You are 18 years or older. - You have sustained trauma (more than 3 months before this study) OR been diagnosed with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) (more than 6 months before this study) OR been diagnosed with Multiple Sclerosis (MS) and suffered visual loss (more than 3 months before this study). - You are willing and able to give written informed consent. - You are able to commit to enrolling in the study during the full time period of up to 6 months. Exclusion Criteria: - You have any other significant ophthalmologic disease or condition (such as glaucoma, retinal degeneration, proliferative diabetic retinopathy, +/- six diopters of myopia, retinal detachment, exudative age-related macular degeneration). - You have amblyopia (lazy eye) in affected eye, previously diagnosed. - You are participating in any other interventional clinical trial. - If you are pregnant OR a woman with childbearing potential who is unwilling to use medically acceptable means of birth control for study duration OR woman unwilling to perform a pregnancy test at study entry/screening. - You are unable to give signed consent due to memory, medical, communication, language, or mental health problems. - You are less than 18 years old. - You are unable or unwilling to complete the evaluation or questionnaire. - Visual acuity better than 20/40 - Inability to detect phosphenes during threshold detection - You are on seizure medications, or have a history of epilepsy.

Additional Information

Official title Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Function After Ocular Trauma
Principal investigator Julia Haller, MD
Description The finely detailed, precise anatomy of the retina and optic nerve capture light impulses from the environment through a biochemical process and then transmit these images to the brain via electrical impulses conducted from the inner retina to the optic nerve and ultimately to the occipital cortex. In the human eye, three types of specialized ganglion cells transmit electrical impulses to the brain. Among these three cell populations are rod and cone cells, which participate in the photo-transduction step of light perception, along with other light sensitive ganglion cells. It is a system whereby the photosensitive pigment rhodopsin (or one of its analogs) rearranges in response to light, and this change in chemical structure fires electrical impulses to the brain which in turn interprets the incoming impulses as a visual image. Transcorneal Electrical Stimulation (TES) using the "OkuStim®" device delivers electrical impulses to damaged and/or diseased photoreceptor cells. This electric stimulation of the retina may help to preserve VA and/or the visual field.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Wills Eye.