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Central Retinal Artery OcclusionNCT00802698

The Effect of Transcorneal Stimulation in Cases of Central Retinal Artery Occlusion Using a New Waveform

A study testing Transcorneal electric stimulation and Transcorneal stimulation in people with Central Retinal Artery Occlusion, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to describe the effect of transcorneal electrical stimulation (TES) with a non conventional biphasic bipolar waveform in central retinal artery occlusion Read more about this study

Who is it for?
Ages 50 to 100 years
Conditions the study is for
Central Retinal Artery Occlusion
What is being tested?
Transcorneal electric stimulation and Transcorneal stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteMexico
Study dates
Apr 2008to Apr 2008
Phase
Interventional
Are there results?
None posted in the registry

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 50 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • central retinal Artery occlusion
  • no retinal diseases associated
  • visual acuity in other eye better than 20/200

Who cannot join

  • Branch retinal artery occlusion

Trial locations and contacts

1 site in 1 country.

Mexico1 site
  • APEC

    México, 04030

Other trials in Mexico

About this study

The purpose of this study is to describe the effect of transcorneal electrical stimulation (TES) with a non conventional biphasic bipolar waveform in central retinal artery occlusion

Read the detailed description

Patients with acute central retinal artery occlusion (CRAO) generally present with a history of painless visual loss that occurred over several seconds. In some instances amaurosis fugax is also present. At the time of initial examination, visual acuity in 90% of patients with CRAO can vary from counting fingers to light perception. Acute CRAO is considered an emergency situation, and therapy must be started as soon as possible. There are different reports where different treatments were proved for the acute phase for example: ocular massage, anterior chamber paracentesis, intravenous mannitol, acetazolamide, hyperbaric oxygenation, microcatheter urokinase infusion, and carbogen 1,2,3. Electrophysiological occlusion of the ophthalmic artery, central retinal artery occlusion, or central retinal vein has a profound impact on the ERG. ERG can provide an objective assessment of severity if occlusion occurs, the b wave is eliminated and a reduction in the "a" wave can be observed.

In addition, a traumatic optic neuropathy, together with retinal ganglion cell death, can induce a loss of vision which progresses rapidly within several hours l. It is known that the visual prognosis following treatment of acute central retinal artery occlusion is not as good as we would like 2; the patient must go to any emergency department to be treated immediately3, in order to preserve maximal visual function. It has been prove that the retinal function recovers after an ischemic event lasting up to 97 minutes, 4 and irreparable damage may occur after 105 minutes. This is why this study intervene during the chronic phase between 4 hrs and 14 days; where demonstrable clinical improvements in the magnitude of retinal damage where seen5, 6, 7 However recently research reports have shown that, electrical stimulation can rescue injured retinal ganglion cells from death cells and can preserve visual function after an optic nerve crush. 8 There is no ideal treatment in the chronic phase of the CRAO. That is the reason why most recent papers suggest different treatment approaches in the chronic phase of this pathology. One of these treatments that were described is the application of electrical stimulation on the patient's cornea who present with CRAO. It has been reported in the literature that transcorneal, retinal 9,10 or cerebral visual cortex 11 electrical stimulation (ES) results in evoked visual sensations (phosphenes),6,9,10,12 however, this intervention requires surgical electrode implantation.

Being tested
Transcorneal electric stimulation, Transcorneal stimulation
Keywords
Biphasic waveform, Central retinal artery occlusion, To describe the effect of Transcorneal Electrical Stimulation (TES) with a non conventional biphasic bipolar waveform, in central retinal artery occlusion
Medical subject headings
Retinal Artery Occlusion

What participants receive

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

  • Transcorneal electric stimulationDevice

    Also called TES

    central artery occlusion

  • Transcorneal stimulationDevice

    Also called TES

    new waveform

  • transcorneal electric stimulationDevice

    Also called TES

    Novel waveform central artery occlusion

Study groups in NCT00802698
Study groupRoleWhat they receive
Group 1ExperimentalNot described
Receives: Device: Transcorneal electric stimulation; Device: Transcorneal stimulation

What is being measured

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

  1. Visual acuity

    Measured: Baseline, Final

Timeline

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

  1. First posted5 Dec 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionApr 2008
  4. Study completionApr 2008

Why it stopped: Undefined

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00802698
Sponsor's protocol ID
APEC-039
Status last verified
May 2024
First submitted
3 Dec 2008
Last updated
30 May 2024
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcorneal electric stimulation and Transcorneal stimulation in people with Central Retinal Artery Occlusion, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.

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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 30 May 2024. 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 Mexico. 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. 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?

The study was stopped early (reason given: Undefined). Results are not available in the source record.

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?

Visual acuity (time frame: Baseline, Final). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 30 May 2024.

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