Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)TESNCT02019927

Electric Stimulation of the Eye to Improve Vision After Trauma

A study testing Transcorneal Electrical Stimulation in people with Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) and Trauma, run by Wills Eye at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-arteritic Anterior Ischemic Optic Neuropathy (NAION), Trauma, Multiple Sclerosis (MS)
What is being tested?: Transcorneal Electrical Stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 97 participants
Where: 1 siteUnited States
Study dates: Jul 2013to Sep 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Wills Eye Hospital
Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

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

Read the 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.

Conditions: Non-arteritic Anterior Ischemic Optic Neuropathy (NAION), Trauma, Multiple Sclerosis (MS)
Being tested: Transcorneal Electrical Stimulation, Sham
Keywords: NAION, Decreased vision, Eye trauma, TES, Electrical stimulation, Multiple Sclerosis, Optic Neuritis
Medical subject headings: Wounds and Injuries, Multiple Sclerosis, Optic Neuropathy, Ischemic, Vision Disorders, Eye Injuries, Optic Neuritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcorneal Electrical StimulationDevice
Also called TES, OkuVision
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.
ShamDevice
Sham

Study groups in NCT02019927
Study group	Role	What they receive
Non-arthritic ischemic optic neuropathy	Experimental	Treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: Device: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (9)

Intra-Ocular Pressure (IOP)
Measured by Applanation (Galdmann) Tonometry method
Measured: Change from Baseline (week 1) to 1-week post initial treatment (week 8)
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.
Measured: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
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
Measured: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
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
Measured: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
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
Measured: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
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
Measured: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
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
Measured: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
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
Measured: Change from Baseline to 1 - week post initial treatment
Symbol Digit Modality Testing
Scores range from 0-110 with higher scores meaning better visual information processing speed
Measured: Change from Baseline to 1 - week post initial treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Sep 2017

First posted24 Dec 2013 (estimated)
Study startJul 2013
Primary completionSep 2017
Study completionSep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 97 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02019927
Sponsor's protocol ID: 12-232
Acronym: TES
Status last verified: Jan 2020
First submitted: 18 Dec 2013
Last updated: 18 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
RecruitingPhase 3
Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Non-Arteritic Anterior Ischemic Optic Neuropathy
RecruitingPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Exosomes for NAION
Eye Diseases, Retinitis Pigmentosa
Not yet recruitingObservational study
NAION in Non-Diabetic Obese Patients Using GLP-1 Receptor Agonists: A Real-World Study
Non-arteritic Anterior Ischemic Optic Neuropathy Obesity, Obesity
RecruitingPhase 1
Evaluating ER-100 for Safety in People With Glaucoma or Non-Arteritic Anterior Ischemic Optic Neuropathy (Optic Nerve Conditions)
Open Angle Glaucoma (OAG), NAION( Non-arteritic Anterior Ischemic Optic Neuropathy)

All Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Function After Ocular Trauma
ClinicalTrials.gov ID: NCT02019927
Acronym / sponsor ID: TES / 12-232
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 97 participants (actual)
Lead sponsor: Wills EyeUniversity, hospital or other
Collaborators: United States Department of Defense
Study start: Jul 2013
Primary completion: Sep 2017 (actual)
Study completion: Sep 2017 (actual)
First posted: 24 Dec 2013 (estimated)
Results: Posted 18 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Non-arthritic ischemic optic neuropathy	Experimental	Device: Transcorneal Electrical StimulationTreatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).
Multiple Sclerosis	Experimental	Device: Transcorneal Electrical StimulationTreatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes).
Ocular Trauma	Experimental	Device: Transcorneal Electrical StimulationTreatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma).
Sham - Non-arthritic ischemic optic neuropathy	Sham comparator	Device: ShamSham treatment of decreased vision due to NAION with the transcorneal electrical stimulation device (6+ months post-event).
Sham - Multiple Sclerosis	Sham comparator	Device: ShamSham treatment of decreased vision due to multiple sclerosis with the transcorneal electrical stimulation device (3+ months post visual changes).
Sham - Ocular Trauma	Sham comparator	Device: ShamSham treatment of decreased vision due to ocular trauma with the transcorneal electrical stimulation device (3+ months post-trauma).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcorneal Electrical StimulationAlso: TES, OkuVisionThe 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.	Device	Multiple Sclerosis, Non-arthritic ischemic optic neuropathy, Ocular Trauma
ShamSham	Device	Sham - Multiple Sclerosis, Sham - Non-arthritic ischemic optic neuropathy, Sham - Ocular Trauma

Primary outcome

Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Acuity
Time frame: Change from Baseline (week 1) to 1-week post initial treatment (week 8)
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.

9 secondary outcomes

Intra-Ocular Pressure (IOP)
Time frame: Change from Baseline (week 1) to 1-week post initial treatment (week 8)
Visual Field Mean Deviation
Time frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Superior Quadrant
Time frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Nasal Quadrant
Time frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Inferior Quadrant
Time frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Temporal Quadrant
Time frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Center Quadrant
Time frame: Change from Baseline (week 1) to 1 - week post initial treatment (week 8)
National Eye Institute's Visual Functioning Questionnaire - 25
Time frame: Change from Baseline to 1 - week post initial treatment
Symbol Digit Modality Testing
Time frame: Change from Baseline to 1 - week post initial treatment

Results and safety

Results posted to the registry on 18 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Non-arteritic Ischemic Optic Neuropathy	46	44
Non-arteritic Ischemic Optic Neuropathy (NAION) Sham	23	19
Multiple Sclerosis	9	8
Multiple Sclerosis Sham	5	3
Ocular Trauma	10	7
Ocular Trauma Sham	4	3

Primary outcome: Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Acuity

Time frame: Change from Baseline (week 1) to 1-week post initial treatment (week 8). Mean (95% Confidence Interval). Unit: logMAR

Measure	Non-arteritic Ischemic Optic Neuropathy n = 46	Sham - Non-arteritic Ischemic Optic Neuropathy n = 23	Multiple Sclerosis n = 9	Sham - Multiple Sclerosis n = 5	Ocular Trauma n = 10	Sham - Ocular Trauma n = 4
Value	-0.23 (-0.30 to -0.17)	-0.14 (-0.23 to -0.05)	-0.08 (-0.22 to 0.06)	-0.06 (-0.25 to 0.13)	-0.29 (-0.45 to -0.12)	-0.05 (-0.3 to 0.2)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non-arteritic Ischemic Optic Neuropathy	0 of 45 (0%)	15 of 45 (33.3%)	0 of 45
Sham - Non-arteritic Ischemic Optic Neuropathy	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Multiple Sclerosis	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9
Sham - Multiple Sclerosis	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Ocular Trauma	0 of 9 (0%)	5 of 9 (55.6%)	0 of 9
Sham - Ocular Trauma	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
RecruitingPhase 3
Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Non-Arteritic Anterior Ischemic Optic Neuropathy
RecruitingPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Exosomes for NAION
Eye Diseases, Retinitis Pigmentosa
Not yet recruitingObservational study
NAION in Non-Diabetic Obese Patients Using GLP-1 Receptor Agonists: A Real-World Study
Non-arteritic Anterior Ischemic Optic Neuropathy Obesity, Obesity
RecruitingPhase 1
Evaluating ER-100 for Safety in People With Glaucoma or Non-Arteritic Anterior Ischemic Optic Neuropathy (Optic Nerve Conditions)
Open Angle Glaucoma (OAG), NAION( Non-arteritic Anterior Ischemic Optic Neuropathy)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Julia Haller, MD principal investigator

Wills Eye Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transcorneal Electrical Stimulation in people with Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) and Trauma, run by Wills Eye at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Acuity (time frame: Change from Baseline (week 1) to 1-week post initial treatment (week 8)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02019927.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.