Electric Stimulation of the Eye to Improve Vision After Trauma

NCT02019927 | Completed Results DMC

• 1 other identifier: 12-232
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

NAION; Decreased vision; Eye trauma; TES; Electrical stimulation; Multiple Sclerosis; Optic Neuritis

Outcome Measures

Primary Outcomes (1)

• Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Acuity

  The primary outcomes are change in high-contrast LogMar VA from baseline (week 1) to initial post treatment (week 8). Participants read letters from a chart and receive 1 point for each letter correctly identified. Scores are converted to logMAR scale and analyzed for changes in visual acuity. Improvement in visual acuity is defined as a decrease in logMAR of 0.2 or more.

  Change from Baseline (week 1) to 1-week post initial treatment (week 8)

Secondary Outcomes (9)

• Intra-Ocular Pressure (IOP)

  Change from Baseline (week 1) to 1-week post initial treatment (week 8)

• Visual Field Mean Deviation

  Change from Baseline (week 1) to 1 - week post initial treatment (week 8)

• Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Superior Quadrant

  Change from Baseline (week 1) to 1 - week post initial treatment (week 8)

• Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Nasal Quadrant

  Change from Baseline (week 1) to 1 - week post initial treatment (week 8)

• Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Inferior Quadrant

  Change from Baseline (week 1) to 1 - week post initial treatment (week 8)

Study Arms (6)

Non-arthritic ischemic optic neuropathy

EXPERIMENTAL

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

Device: Transcorneal Electrical Stimulation

Multiple Sclerosis

EXPERIMENTAL

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

Device: Transcorneal Electrical Stimulation

Ocular Trauma

EXPERIMENTAL

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

Device: Transcorneal Electrical Stimulation

Sham - Non-arthritic ischemic optic neuropathy

SHAM COMPARATOR

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

Device: Sham

Sham - Multiple Sclerosis

SHAM COMPARATOR

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

Device: Sham

Sham - Ocular Trauma

SHAM COMPARATOR

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

Device: Sham

Interventions

Transcorneal Electrical Stimulation 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.

Also known as: TES, OkuVision

Multiple Sclerosis; Non-arthritic ischemic optic neuropathy; Ocular Trauma

Sham DEVICE

Sham

Sham - Multiple Sclerosis; Sham - Non-arthritic ischemic optic neuropathy; Sham - Ocular Trauma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wills Eye: lead
• United States Department of Defense: collaborator

Study Sites (1)

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Multiple Sclerosis; Optic Neuropathy, Ischemic; Vision Disorders; Eye Injuries; Optic Neuritis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases; Vascular Diseases; Cardiovascular Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System

Results Point of Contact

• Title: Ann Murchison MD
• Organization: Will Eye Hopsital

Visionresearch@willseye.org

267-733-9617

Study Officials

• Julia Haller, MD

  Wills Eye Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Evaluation of the Effectiveness of Transcorneal Electrical Stimulation to Improve Visual Function Following Ocular Trauma

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 24, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: January 18, 2020
• Results First Posted: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)