Electric Stimulation of the Eye to Improve Vision After Trauma (TES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Wills Eye
Sponsor:
Information provided by (Responsible Party):
Brian Burke, MPH, Wills Eye
ClinicalTrials.gov Identifier:
NCT02019927
First received: December 18, 2013
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Non-arteritic Anterior Ischemic Optic Neuropathy
Decreased Vision Due to Ocular Trauma
Device: Transcorneal Electrical Stimulation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Function After Ocular Trauma

Resource links provided by NLM:


Further study details as provided by Wills Eye:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 9-month period ] [ Designated as safety issue: No ]
    The primary outcomes are change in high-contrast LogMar VA and change in low-contrast LogMar VA from baseline (week 1) to initial post treatment (week 8). Each outcome will be modeled separately.


Secondary Outcome Measures:
  • Diagnostic testing [ Time Frame: 9-month period ] [ Designated as safety issue: Yes ]
    Secondary outcomes are change in visual field mean deviation, contrast sensitivity, Visual Evoked Potential results (peak latency, amplitude of the p100 wave), Intraocular Pressure, Ocular Coherent Tomography nerve thickness, National Eye Institute-Visual Functioning Questionnaire-25 total score and subscores, and Symbol Digit Modalities Test total score


Estimated Enrollment: 126
Study Start Date: July 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Non-arteritic ischemic optic neuropathy
Treatment of decreased vision due to NAION with transcorneal electrical stimulation device.
Device: 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 acute ocular trauma, patients with chronic ocular trauma and patients with Non-arteritic Anterior Ischemic Optic Neuropathy.
Other Names:
  • TES
  • OkuVision
Active Comparator: Acute trauma (3-6 motnhs post-trauma)
Treatment of decreased vision due to acute ocular trauma with transcorneal electrical stimulation device.
Device: 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 acute ocular trauma, patients with chronic ocular trauma and patients with Non-arteritic Anterior Ischemic Optic Neuropathy.
Other Names:
  • TES
  • OkuVision
Active Comparator: Chronic trauma (6+ months post-trauma)
Treatment of decreased vision due to chronic ocular trauma with the transcorneal electrical stimulation device.
Device: 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 acute ocular trauma, patients with chronic ocular trauma and patients with Non-arteritic Anterior Ischemic Optic Neuropathy.
Other Names:
  • TES
  • OkuVision

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • You are 18 years or older.
  • You have sustained trauma (either acute ophthalmic trauma (3-6 months before this study) OR chronic ophthalmic trauma (more than 6 months before this study) OR been diagnosed with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) (more than 6 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02019927

Contacts
Contact: Carrie Hanson, MPH 215-928-3937 chanson@willseye.org

Locations
United States, Pennsylvania
Wills Eye Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Carrie Hanson, MPH    215-928-3937    chanson@willseye.org   
Sub-Investigator: Robert Sergott, MD         
Sub-Investigator: Mark Moster, MD         
Sub-Investigator: Juri Bilyk, MD         
Sub-Investigator: Anna Murchison, MD         
Sub-Investigator: Omesh Gupta, MD         
Sub-Investigator: Larry Donoso, MD         
Sub-Investigator: Esther Bisker, MD         
Sub-Investigator: Timothy Kim, MD         
Sub-Investigator: Nicholas Biro, MD         
Principal Investigator: Julia Haller, MD         
Sponsors and Collaborators
Wills Eye
Investigators
Study Director: Brian Burke, MPH Wills Eye Hospital
  More Information

No publications provided

Responsible Party: Brian Burke, MPH, Evaluation of the Effectiveness of Transcorneal Electrical Stimulation to Improve Visual Function Following Ocular Trauma, Wills Eye
ClinicalTrials.gov Identifier: NCT02019927     History of Changes
Other Study ID Numbers: 12-232
Study First Received: December 18, 2013
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Wills Eye:
NAION
Decreased vision
Eye trauma
TES
Electrical stimulation

Additional relevant MeSH terms:
Vision, Low
Optic Nerve Diseases
Wounds and Injuries
Optic Neuropathy, Ischemic
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014