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

December 4, 2008 updated by: Asociación para Evitar la Ceguera en México
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

5

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Miriam Jessica Lopez-Miranda, MD
  • Phone Number: 1171 10841400
  • Email: retinamex@yahoo.com

Study Contact Backup

Study Locations

  • Mexico
      • Mexico, Mexico, 04030
        • Recruiting
        • APEC
        • Contact:
        • Sub-Investigator:
          • Daniel Robles-Camarillo, MSc
        • Sub-Investigator:
          • Hugo Quiroz -Mercado, MD
        • Sub-Investigator:
          • Luis Niño-de-Rivera y Oyarzabal, PhD
        • Sub-Investigator:
          • Virgilio Morales-Cantón, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Branch retinal artery occlusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1
Device: Transcorneal electric stimulation
central artery occlusion
Other Names:
  • TES
Device: Transcorneal stimulation
new waveform
Other Names:
  • TES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual acuity
Time Frame: Baseline, Final
Baseline, Final

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asociación para Evitar la Ceguera en México

Investigators

  • Principal Investigator: Miriam Jessica Lopez-Miranda, MD, Asociación Para Evitar la Ceguera en México

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ANTICIPATED)

April 1, 2008

Study Registration Dates

First Submitted

December 3, 2008

First Submitted That Met QC Criteria

December 4, 2008

First Posted (ESTIMATE)

December 5, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 5, 2008

Last Update Submitted That Met QC Criteria

December 4, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APEC-039

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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