Electric Stimulation of the Eye to Improve Vision After Trauma

NCT ID: NCT02019927

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2017-09-30

Brief 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.

Detailed 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.

Conditions

Non-arteritic Anterior Ischemic Optic Neuropathy (NAION); Trauma; Multiple Sclerosis (MS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Non-arthritic ischemic optic neuropathy

Treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).

Group Type: EXPERIMENTAL

Transcorneal Electrical Stimulation

Intervention Type: DEVICE

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.

Multiple Sclerosis

Treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes).

Group Type: EXPERIMENTAL

Transcorneal Electrical Stimulation

Intervention Type: DEVICE

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.

Ocular Trauma

Treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma).

Group Type: EXPERIMENTAL

Transcorneal Electrical Stimulation

Intervention Type: DEVICE

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.

Sham - Non-arthritic ischemic optic neuropathy

Sham treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

Sham

Sham - Multiple Sclerosis

Sham treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes).

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

Sham

Sham - Ocular Trauma

Sham treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma).

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

Sham

Interventions

Transcorneal Electrical Stimulation

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.

Intervention Type: DEVICE

Sham

Sham

Intervention Type: DEVICE

Other Intervention Names

TES; OkuVision

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Wills Eye

OTHER

Sponsor Role: lead

Responsible Party

Julia Haller

Evaluation of the Effectiveness of Transcorneal Electrical Stimulation to Improve Visual Function Following Ocular Trauma

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julia Haller, MD

Role: PRINCIPAL_INVESTIGATOR

Wills Eye Hospital

Locations

Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

12-232

Identifier Type: -

Identifier Source: org_study_id