Electric Stimulation of the Eye to Improve Vision After Trauma

Trauma Clinical Trial

— TES  

Official title:

Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Function After Ocular Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02019927
• Other study ID #: 12-232
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: September 2017

Study information

• Verified date: January 2020
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis (MS)
• Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
• Optic Nerve Diseases
• Optic Neuropathy, Ischemic
• Sclerosis
• Trauma
• Wounds and Injuries

Intervention

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 ocular trauma, patients with optic neuritis associated with multiple sclerosis and patients with Non-arteritic Anterior Ischemic Optic Neuropathy.
• Sham
Sham

Locations

Country	Name	City	State
United States	Wills Eye Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Wills Eye	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intra-Ocular Pressure (IOP)	Measured by Applanation (Galdmann) Tonometry method	Change from Baseline (week 1) to 1-week post initial treatment (week 8)
Secondary	Visual Field Mean Deviation	The Humphrey 24-2 Swedish Interactive Threshold Algorithm Standard perimeter was used to test visual field. Reported values are a change from baseline to 1-week post initial treatment.	Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Secondary	Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Superior Quadrant	Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline	Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Secondary	Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Nasal Quadrant	Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline	Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Secondary	Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Inferior Quadrant	Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline	Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Secondary	Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Temporal Quadrant	Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline	Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Secondary	Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Center Quadrant	Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline	Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Secondary	National Eye Institute's Visual Functioning Questionnaire - 25	Test to measure Unweighted of scores within test ranging from 0-100 with higher scores meaning better outcome	Change from Baseline to 1 - week post initial treatment
Secondary	Symbol Digit Modality Testing	Scores range from 0-110 with higher scores meaning better visual information processing speed	Change from Baseline to 1 - week post initial treatment